Download Ayman Sobhy Elsayed Mustafa_1. AUB

Endometrial ablation: A Comparative Study between
Hysteroscopic Resection and modified Thermal Balloon
using Foley’s Catheter in The Treatment of Dysfunctional
Menorrhagia
Thesis
Submitted for partial fulfillment of MD degree in Obstetrics and Gynecology
BY
Ayman Sobhy El-Gohary
Assistant lecturer of Obstetrics and Gynecology
Faculty of medicine – Benha University
Under supervision of
Prof. AHMED AHMED SALEM
Professor of Obstetrics and Gynecology
Faculty of medicine – Benha University
Dr. MOHAMMED ABDEL-HADY MOHAMMED
Assistant professor of Obstetrics and Gynecology
Faculty of medicine – Benha University
Dr. IBRAHIM IBRAHIM SWEDAN
Lecturer of Obstetrics and Gynecology
Faculty of medicine – Benha University
Faculty of medicine
Benha University
2016
ABSTRACT
Abstract Study design: A randomized clinical prospective comparative study.
Setting: The study was conducted in the Department of Obstetrics and Gynecology
in Benha University between January 2014 and December 2015.
Objective: To compare the efficacy and safety of endometrial ablation using
Foley’s catheter with hysteroscopic endometrial resection in the treatment of
dysfunctional menorrhagia.
Patients and methods: The study comprised 100 premenopausal women with
persistent intractable menorrhagia, selected under strict inclusion criteria. Patients
were randomized into two equal groups of 50 patients each. Patients of the first
group were treated by Foley’s catheter endometrial ablation (30 patients), while
those of the other group were treated by hysteroscopic endometrial resection (50
patients). Pre and post-procedural quantification of menstrual blood was defined by
pad count and self-assessment. Eighteen-month follow-up data were presented on
all women and compared statistically.
Results: Eighteen-month results indicated that both techniques significantly
reduced menstrual blood flow with no clinically significant difference between the
two groups. Success rates, as reflected by percent of patients who returned to
normal bleeding or less, were comparable being 80% for the Foley’s catheter
ablation group and 86.6% for the resection group. Procedural time was reduced
significantly in the Foley’s catheter endometrial ablation group. Intra-operative
complications occurred in three (8.5%) of the hysteroscopic resection patients,
whereas no intra-operative complications occurred in the thermal balloon group.
Postoperative complications were occurred in 3 patients in each group.
Conclusion: Foley’s catheter endometrial ablation is as efficacious as
hysteroscopic resection in the treatment of selected cases of menorrhagia.
Keywords: Menorrhagia; Foley’s catheter; Hysteroscopic ablation; resectscope
-2-
LIST OF TABLES
No.
Page
Description
1
13
Terminology of AUB, according to FIGO (2011)
2
14-15
Description of AUB, according to FIGO (2011)
3
16
PALM-COEIN classification of AUB
4
39
Types of distention media for hysteroscopy
5
75
The demographic and gynecological data in study groups
6
76
The operative time (min.), postoperative Hb drop (%)
and hospital stay (Hrs.) in study groups.
7
79
Menstrual flow before and after treatment in Foley’s
catheter group.
8
79
Menstrual flow before and after treatment in resection
group.
9
80
Post treatment pattern in both groups at last visit (12
months).
-3-
LIST OF FIGURES
No.
Page
Description
1
18
PBAC scoring system
2
19
The menstrual pictogram
3
43
Thermachoice system for endometrial ablation.
4
44
Cavaterm system for endometrial ablation.
5
44
Thermablate system (EAS) for endometrial ablation.
6
45
Novasure system for endometrial ablation.
7
45
Her Option system for endometrial ablation.
8
46
Microsulis system for endometrial ablation.
9
72
Foley’s catheter No. 18 French
10
73
The resectoscope elements.
-4-
LIST OF CHARTS
No.
Page
Description
1
77
Intra and postoperative complications in Foley's catheter group.
2
78
Intra and postoperative complications in hysteroscopic resection
group.
3
78
Intra and postoperative complications in study groups
4
81
Changes in the bleeding pattern, over time, after Foley’s catheter
ablation.
5
82
Changes in the bleeding pattern, over time, after hysteroscopic
resection.
-5-
LIST OF ABBREVIATIONS
AAGL: Advancing Minimally Invasive Gynecology Worldwide.
ACOG: American College of Obstetricians and Gynecologists.
aPTT: activated partial thromboplastin time.
ARDS: Adult respiratory distress syndrome.
ASRM: American Society for Reproductive Medicine.
AUB: Abnormal uterine bleeding.
BMI: Body mass index.
C: Celsius.
CBC: Complete blood count.
CHCs: Combined oral contraceptive.
cm: centimeter.
D&C: Dilatation and curettage.
DMPA: Depomedroxy progesterone acetate.
DUB: Dysfunctional uterine bleeding.
EA: Endometrial ablation.
F: French
FCBEA: Foley’s catheter balloon endometrial ablation
FDA: Food and Drug Administration.
FIGO: International Federation of Gynecology and Obstetrics.
GHz: Gigahertz.
-6-
Gn-RH: Gonadotropin releasing hormone.
Hb: Hemoglobin.
HMB: Heavy menstrual bleeding.
Hrs: hours.
HE: hyponatremic encephalopathy.
IV: Intravenous
LNG-IUS: Levonorgestrel releasing intrauterine system.
MEA: microwave endometrial ablation.
mEq: miliequilibrium.
mg: milligram.
min: minute.
mm: millimeter
MPA: Medroxy progesterone acetate.
MRI: Magnetic Resonance Image.
NaCl: Sodium Chloride
NICE: National Institute for Health and Clinical Excellence.
NS: No significant.
NSAIDs: Nom steroidal anti-inflammatory drugs.
OCP: Oral contraceptive pills.
PBAC: Pictorial blood loss assessment chart.
PCO: Polycystic ovary.
PMS: Premenstural tension syndrome.
-7-
PT: Prothrombin time.
RB: Roll ball
RCTs: Randomized controlled trials.
SIS: Saline infusion sonohysterography.
SOGC: Society of Obstetricians and Gynecologists of Canada.
TBEA: Thermal balloon endometrial ablation.
TCRE: Transcervical endometrial resection.
TVS: Transvaginal sonograpghy.
UAE: Uterine artery embolization.
UK: United Kingdom.
Vs: versus.
VWF: von Willebrand’s factor.
W: Watt.
-8-
INTRODUCTION
Heavy menstrual bleeding (HMB, also known as menorrhagia) is a
significant cause of morbidity in premenopausal women. It is objectively defined
as menstrual blood loss of more than 80 ml/cycle, or menstrual bleeding lasting
longer than 7 days, over several consecutive cycles. However, in practice, the
diagnosis is based on the woman's subjective assessment of blood loss (Munro et
al., 2010).
It is estimated that 1 in 20 women aged 30–49 years consults her general
practitioner each year with HMB. Referrals for menstrual disorders account for
about 20% of all referrals to specialist gynaecology services, placing a significant
burden on secondary healthcare services (National Institute for Health and Care
Excellence “NICE”, 2004).
Heavy menstrual bleeding has adverse implications for quality of life.
Women with HMB may have difficulties with daily activities such as work, social
activities, hobbies and holidays. Many women report anxiety, depression,
embarrassment and problems in their sex lives because of HMB. Anemia is also
common amongst women with HMB, and this may further impair quality of life
(Gokyildiz et al., 2013).
The cause of HMB is not known in the majority of cases, in which no pelvic
or organic pathology is identified. However, HMB may have structural organic
causes such as fibroids, adenomyosis, polyps, infections, pre-cancerous conditions
or hematological disorders (Frick et al., 2009).
Diagnosis of HMB is complex and is usually based on subjective evaluation
of blood loss by the affected individuals. The blood loss can be estimated using
-9-
pictorial blood-loss assessment charts (PBACs); this method takes into account the
number of items of sanitary wear used and the degree of staining of each item. A
PBAC score greater than 100 would normally indicate HMB. Although the 'gold
standard' method of measuring blood loss is the alkaline haematin technique,
which requires women to collect their used sanitary wear, this technique is rarely
used outside research settings (The menorrhagia research group, 2004).
Treatment of HMB aims to reduce menstrual loss and hence to improve the
quality of life of the individuals. First-line treatment is drug therapy. The most
commonly used drugs are tranexamic acid (an antifibrinolytic drug), mefenamic
acid (a non-steroidal anti-inflammatory drug) and combined oral contraceptives.
NICE recommend that drug treatment should be given for at least three cycles
before considering another treatment option. Another alternative sometimes used
before surgical intervention is a levonorgestrel-releasing intrauterine system
(LNG-IUS) (NICE, 2004).
Surgical treatment is usually offered to patients who do not respond to drug
treatment. Hysterectomy is the only treatment for HMB that guarantees
amenorrhoea, but it is associated with peri- and postoperative complications,
including incontinence and other urinary problems, fatigue, infection, pelvic pain
and sexual problems. Overall, 1 in 30 women suffers a major adverse event during
or soon after the operation. Additionally, the procedure has a mortality rate of 0.4–
1.1 per 1000 operations. Hysterectomy is costly and has significant resource
implications because it requires general anesthesia, long operating theatre times
and a hospital stay of up to 7 days after the operation. Full recovery may take 1-3
months (Society of Obstetricians and Gynecologists of Canada “SOGC”, 2013)
-10-
Many women who are referred to secondary care for HMB will eventually
undergo hysterectomy. It is estimated that HMB was the presenting complaint in
about half of these cases. Furthermore, about half of all women who have a
hysterectomy for HMB are believed to have a normal uterus removed (American
College of Obstetricians and Gynecologists “ACOG”, 2013).
First-generation endometrial ablation (EA) techniques were introduced
almost 20 years ago as alternatives to hysterectomy. These techniques aim to
reduce the menstrual bleeding by destroying (ablating) the entire thickness of the
innermost layer of the uterus (the endometrium) and some of the underlying
muscular layer (the myometrium) using electrical, thermal or laser energy. EA
techniques do not guarantee amenorrhoea, but are less invasive and require fewer
resources than hysterectomy. EA techniques are not suitable for women who wish
to maintain fertility (Papadopoulos and Magos, 2007).
The most widely used first-generation EA techniques are transcervical
resection of endometrium (TCRE), using a loop diathermy electrode, and rollerball ablation (RB), using an electrode with a movable ball or cylinder. All firstgeneration EA techniques require direct visualisation of the endometrium using a
hysteroscope. The success rates of these techniques depend heavily on the skills
and experience of the operator (Deb et al., 2008).
Possible perioperative adverse effects with the first generation EA
techniques include electrosurgical burns, uterine perforation, hemorrhage,
infection, and fluid overload (which may cause congestive cardiac failure,
hypertension, hemolysis, coma and death) (Daniel et al., 2012).
Second-generation EA techniques have been introduced with the aim of
providing simpler, quicker and more effective treatment options for HMB
-11-
compared with first-generation EA techniques and hysterectomy. These techniques
are less operator-dependent, but they rely heavily on the devices themselves to
ensure safety and efficacy. Second-generation EA techniques include fluid-filled
thermal balloon EA (TBEA), radiofrequency balloon EA, hydrothermal EA, 3D
bipolar radiofrequency EA, microwave EA (MEA), diode laser hyperthermy,
cryoablation and photodynamic therapy (Owusu-Ansah et al., 2006).
The most frequently used second- generation EA techniques in clinical
practice is fluid filled TBEA which do not require direct visualisation of the uterine
cavity, and can be carried out under either local or general anaesthesia. It destroys
the inner layers of the uterus by transferring heat from heated liquid within a
balloon inserted into the uterine cavity. (Thermachoice, Thermablate EAS, and
Cavaterm) are the 3 devices which have been approved by Food and Drug
Administration (FDA) for TBEA. All involve an electronic controller, a single-use
latex or silicone balloon catheter housing a heating element (Rishma, 2009).
Although TBEA devices are safe, effective and easily used, they have the
disadvantage of being expensive and unavailable in many centers, so the use of
Foley’s catheter balloon in this study can be a cheap and available alternative to
these devices in low resources countries. However, Foley’s catheter balloon has the
disadvantage of absence of the control unit which allows proper setting and
monitoring of temperature and pressure, thus the use of this simple technique will
be assessed in this study (Azza, 2012).
-12-
Chapter (1): ABNORMAL UTERINE BLEEDING (AUB)
Menstrual disorders are a common indication for gynecological visits among
women of reproductive age. Heavy menstrual bleeding (HMB) affects up to 30%
of these disorders (Pallavi et al., 2015). These complaints can affect life quality;
result in time off work which may lead to hysterectomy (Frick et al., 2009).
Abnormal uterine bleeding can be defined as any variation from the normal
menstrual cycle which includes regularity and frequency changes of the menses, in
flow duration, or in blood loss amount. Under the category of AUB, further
definitions may be subdivided based on regularity, frequency, duration, volume,
timing, and chronicity of the menstrual cycle (Munro, 2010).
Standardized universal terminology is essential in the discussion of AUB. In
2011, the International Federation of Gynecology and Obstetrics (FIGO) Menstrual
Disorders Working Group developed a new guideline for the terminology and
descriptions related to this topic; as shown in table (1) and (2). This suggested
nomenclature for AUB aims to simplify descriptions of this clinical presentation
and eliminate terminology such as menorrhagia and metrorrhagia. The term
menorrhagia should be replaced by heavy menstrual bleeding (HMB) and the term
metrorrhagia should be replaced irregular menstrual bleeding (Munro et al., 2011).
Table (1): Terminology of AUB, according to FIGO (2011)
Volume
Heavy
Normal
Light
Regularity
Irregular
Regular
Absent
Frequency
Frequent
Normal
Infrequent
-13-
Duration
Prolonged
Normal
Shortened
Other
Intermenstrual
Premenstrual
Breakthrough
Table (2): Description of AUB, according to FIGO (2011)
Characteristic
Terminology
Description
Volume
Heavy menstrual bleeding
Regularity
Irregular menstrual bleeding
Excessive menstrual blood loss
which interfere with the women`s
physical, emotional, social and
material quality of life,
A range of varying lengths of
bleeding-free intervals >20 days
within one 90-day reference
period.
Frequency
(Normal = every
24-38 days)
Duration
(Normal = 3-8
days)
Absent menstrual bleeding
(amenorrhea)
Infrequent menstrual bleeding
No bleeding in a 90-day period
Frequent menstrual bleeding
Bleeding at intervals < 24 days
(> 4 episodes in a 90-day period)
Menstrual blood loss > 8 days in
duration.
Prolonged menstrual bleeding
Shortened menstrual bleeding
Irregular, Nonmenstrual
Intermenstural
Bleeding at intervals > 38 days
apart (1 or 2 episodes in a 90-day
period).
Menstrual bleeding < 3 days in
duration.
Irregular episodes of bleeding,
often light and short, occurring
between otherwise fairy normal
menstrual periods.
Post-coital
Bleeding post-intercourse.
Pre-menstrual and post
menstrual spotting
Bleeding that may occur on
regular basis > 1 days before or
after the recognized menstrual
period.
-14-
Bleeding outside Post-menopausal bleeding
reproductive age
Precocious menstruation
Acute or chronic Acute AUB
AUB
Bleeding occurring > 1 year after
menopause.
Bleeding occurring before the age
of 9 years.
An episode of bleeding in a
woman of reproductive age, who
is not pregnant, that is of
sufficient quality to require
immediate intervention to prevent
further blood loss.
Bleeding that is abnormal in
duration,
volume,
and/or
frequency and has been present
for most of the last 6 months
Chronic AUB
CAUSES OF AUB:
In 2011, an international expert committee from the FIGO Menstrual
Disorders Working Group has proposed a standardized classification system for
AUB. This classification allows the characterization of more than one etiology in
the same patient. The term “dysfunctional uterine bleeding” should be replaced by
coagulopathy, ovulation disorder, or endometrial disorder.
There are 9 main categories within the classification system which is named
PALM-COEIN; as shown in table (3). The PALM side of the classification refers
to structural causes that could be diagnosed by radiological imaging or biopsy. The
COEIN side refers medical causes that could result in AUB (Munro et al., 2011).
-15-
Table (3): PALM-COEIN classification of AUB
PALM-side (structural causes)
COEIN-side (Non-structural causes)
Polyps
Coagulopathy
Adenomyosis
Leiomyomas
-Submucous
-other
Malignancy & hyperplasia
Ovulatory dysfunction
Endometrial (primary disorder of
mechanisms regulating local endometrial
hemostasis)
Iatrogenic
Not yet specified
DIAGNOSIS OF AUB:
Assessment, history and physical examination will help to establish the
cause of the abnormal bleeding, to direct further investigations, and to guide
options for management.
I. Assessment of heavy menstrual bleeding:
The current ‘gold standard’ method of estimating blood loss is the alkaline
hematin technique (Hallberg and Nilsson, 1964). Gannon et al. (1996) has been
modified this method to simplify and fasten the process but all modifications
require women to collect their used sanitary wear. This is subsequently treated to
extract hemoglobin, which is then measured and related back to actual blood loss.
This method is rarely used outside a research setting (Reid et al., 2000).
Pictorial blood loss assessment chart (PBAC) is another method of
estimating of the menstrual blood loss. This is a simple scoring system which was
first introduced by Higham et al. (1990) as a visual representation of blood loss
from which a numerical score is emerged. The chart composed of varieties of
-16-
diagrams representing lightly, moderately and heavily soiled tampons or towels.
Moreover, passage of blood clots (size equated with that of UK coins) and flooding
episodes were recorded (Fig. 1). A numerical scoring system was developed to
estimate the blood loss amount. The scores assigned were 1 for each lightly stained
tampon, 5 if moderately soiled and 10 if it was completely saturated with blood.
The towels were given scores of 1, 5 and 20, with increased level of soiling. Small
and large clots scored 1 and 5, respectively (The menorrhagia research group,
2004).
Higham et al. (1990) reported that when the PBAC was used as a diagnostic
clinical tool, a score of 100 or more defined menorrhagia with a sensitivity and
specificity of > 80%.
Janssen et al. (1995) assessed the specificity, sensitivity, and negative and
positive predictive values of PBACs at several cut-off points. Using a score of 185
as their cut-off point, the authors reported predictive values of negative and
positive tests of 84.8%, and 85.9% respectively.
The discriminatory power of PBAC as a diagnostic method was a matter of
question. Reid et al. (2000) showed that, in a group of 103 women with
menorrhagia; there was poor correlation between actual measured blood loss and
PBAC score.
The main 2 drawbacks for this score were that; the specific sanitary products
that were used for the Higham technique are not now widely available, which may
make it less accurate. Furthermore, methods that rely on directly or indirectly
estimating blood loss from the effect on sanitary wear do not take account of blood
loss during changing sanitary wear (Wyatt et al., 2001).
-17-
Another indirect method for assessing blood loss is the ‘menstrual
pictogram’ (Fig. 2). It is similar to the PBAC but has 2 additional values for the
modified charts, the first is that the score is calculated in milliliters and so, it is
equal to the actual volume of blood lost. The second is the estimation of the blood
loss during changing sanitary wear is considered. For these reasons, the menstrual
pictogram appears to be an accurate and acceptable way of estimating menstrual
blood loss for both research and clinical uses (The menorrhagia research group,
2004).
Figure (1): PBAC scoring system
-18-
Figure (2): The menstrual pictogram
-19-
II. HISTORY:
Assessing the amount, frequency, and regularity of bleeding, the presence of
post-coital or intermenstrual bleeding, and any dysmenorrhea or premenstrual
symptoms can help to differentiate between ovulatory from anovulatory bleeding
or to diagnose anatomic causes such as cervical pathology or endometrial polyps.
Ovulatory AUB is usually regular and is usually associated with dysmenorrhea and
premenstrual symptoms while anovulatory bleeding, which is more common near
menarche and the perimenopause, is usually irregular, heavy, and prolonged. It is
more likely to be associated with endometrial hyperplasia and cancer (ACOG,
2013).
Further history should include the following (SOGC, 2013):
• Symptoms suggestive of anemia (i.e. pallor, headache, shortness of breath with
activity).
• Sexual and reproductive history (i.e. contraception, infertility, sexually
transmitted diseases risk for pregnancy and desire for future pregnancy, cervical
screening).
• Symptoms suggestive of systemic causes of bleeding such as; coagulation
disorders, hyperprolactinemia, and hypothyroidism.
• Associated symptoms such as pelvic pain and vaginal discharge or odor.
• A family history of inherited coagulation disorders, PCOS, or endometrial cancer.
• A Past history of any co-existing conditions includes: cardiovascular problems
thromboembolic disease, hormonally dependent neoplasm, or that; could affect
options of treatment. Finally, a list of drugs that may interfere with ovulation or
-20-
otherwise be associated with bleeding should be obtained (anticoagulant, antidepressant, anti-psychotic, hormonal contraception, tamoxifen, corticosteroids,
and herbs: ginseng)
II. EXAMINATION:
Physical examination should look for evidence of systemic disorders that
can cause abnormal bleeding and should evaluate the abdomen, lower genital tract
and pelvis to confirm the source of bleeding and to search for anatomical causes
such as myomas or cervical polyps.
General examination includes: vital signs (pulse, blood pressure,
temperature, and respiratory rate), weight, thyroid, and skin (pallor, bruising,
striae, hirsutism and petechiae).
Abdominal examination should be done to exclude any mass, ascites, and
hepato-splenomegally.
Gynecological examination includes: inspection (vulva, vagina, cervix, anus
and urethra), bimanual exam (uterus and adnexal mass), rectal exam (if bleeding
from anus is suspected), uretheral exam (if bleeding from urethra is suspected) and
testing (Pap smear and cervical cultures if risk for sexually transmitted infection)
(NICE, 2007).
III. INVESTIGATIONS:
Investigations include the following:
1. Laboratory investigations:
-21-
Many laboratory investigations may be done including (Khrouf and
Khaled, 2014):
 A complete blood count (CBC) is recommended if there is a history of
HMB.
 If there is any possibility of pregnancy, serum beta subunit for human
chorionic gonadotropin (β-HCG) should be carried out.
 Thyrotropin stimulating hormone (TSH) levels should be measured only if
there are other symptoms or findings suggestive of thyroid disease.
 Testing for coagulation disorders should be done in patients who have a
history of heavy bleeding beginning at menarche, a history of postpartum
hemorrhage or hemorrhage with dental extraction, evidence of other
bleeding problems, or a family history suggesting a coagulation disorder.
 There is no evidence that measurement of serum gonadotropins, estradiol,
or progesterone levels is helpful in the management of AUB.
2. Transvaginal sonography (TVS):
Transvaginal sonography (TVS) can diagnose the majority of anatomical
abnormalities of the uterus and endometrium. In addition, pathologies of the
myometrium, cervix, tubes, and ovaries can be assessed. This investigative method
can help in the diagnosis of adenomyosis, leiomyomas, endometrial polyps, uterine
anomalies, and endometrial thickening associated with hyperplasia and cancer. In a
premenopausal woman, the normal endometrium varies in thickness according to
the menstrual cycle from 4 mm in the follicular phase up to 16 mm in the luteal
phase (Veena and Nermala, 2014).
-22-
3. Saline infusion sonohysterography (SIS):
Saline infusion sonohysterography (SIS) is a technique in which 5 to 15 mL
of normal saline is introduced into the uterine cavity during TVS. So, it improves
the diagnosis of intracavitary pathology. Especially in cases of endometrial polyps
and myomas, SIS allows a greater discrimination of site and relationship to the
uterine cavity. Although hysteroscopy is the gold standard, SIS is an easy, simple
and safe technique for diagnosing of intracavitary pathologies. SIS can reduce the
need for hysteroscopy but it is less sensitive (Sharma at al., 2013).
4. Magnetic resonance image (MRI):
In patients with HMB, MRI is rarely used to evaluate the endometrium.
However, it can be helpful in mapping the site of myomas in surgical planning and
prior to uterine artery embolization. It can be used in assessing the endometrial
cavity when TVS or other uterine imaging (i.e. congenital anomalies) is not
conclusive (Kotdawala, 2013).
5. Hysteroscopy:
Hysteroscopic evaluation for abnormal uterine bleeding is an option
providing direct visualization of intra-cavitary pathology and facilitating directed
biopsy (Van Dongen et al., 2007).
6. Endometrial biopsy:
In women at risk of malignancy, endometrial biopsy is a minimally invasive
method for endometrial evaluation. Sensitivity for malignancy is higher in
postmenopausal women than in premenopausal women (Huang et al., 2007).
-23-
This biopsy can detect over 90% of endometrial cancers. However, it is a
blind procedure and therefore it can miss a focal lesion; so, hysteroscopic directed
biopsy is recommended in the cases of a focal lesion when is suspected on
ultrasound (Huang et al., 2007).
Indications for endometrial biopsy in women with AUB include (Lacey et
al., 2010):
 Age > 40.
 Failure of medical treatment.
 Significant intermenstrual bleeding.
 Risk factors for endometrial cancer (BMI > 30 kg/m2, nulliparous, PCOs,
and diabetes).
7. Dilatation and Curettage:
Dilatation and curettage (D&C) is no longer used for the initial evaluation of
the endometrium. The advantage of D&C is to add the endometrial assessment
pathology in the diagnosis. The disadvantages of this procedure include; it is a
blind procedure, with sampling errors and risks of complications similar to
hysteroscopy (La Sala et al., 2011).
TREATMENT OF AUB:
I. MEDICAL TREATMENTS:
In the treatment of women with AUB, once a detailed history, physical
examination, and imaging studies are done and all significant structural causes are
excluded, medical treatment is the first-line approach (Bradley and Gueye, 2016).
-24-
Treatment for any associated medical condition that can cause menstrual
bleeding, such as hypothyroidism, should be started before to the addition of any
medical drugs. Patients whom found to be anemic due to AUB, iron
supplementation should be started immediately (Sweet et al., 2012).
Regular menstrual bleeding can be treated effectively with both hormonal
and non-hormonal options. Non-hormonal treatments such as non-steroidal antiinflammatory drugs and antifibrinolytics are used during menses to reduce the
amount of blood loss (Ray and Ray, 2014).
Irregular bleeding is most successfully treated with hormonal options which
can regulate cycles, decreasing the episodes of heavy bleeding. combined
hormonal contraceptives, Cyclic progestin and LNG-IUS are effective treatment in
this group, allowing more predictable cycles while protecting the endometrium
against unopposed estrogen and the risk of hyperplasia or cancer (Ray and Ray,
2014).
Regard to any type of AUB, a patient- centered approach to the selection of
a specific medical therapy is essential. Satisfaction and continuation of any given
treatment will be affected not only by the efficacy, but also by the individual
patient’s goals and tolerance of side effects. The decision to proceed with a trial of
medical treatment should be based on a patient counseling, desire for future
fertility or contraception, underlying medical disorders or contraindications,
presence of dysmenorrhea, and bleeding severity (SOGC, 2013).
II. SURGICAL TREATMENTS:
Surgical treatment of AUB requires a detailed assessment of the underlying
pathology and patient factors. The medical treatment of HMB is effective for many
-25-
patients, and treatment with the LNG-IUS may be comparable in results to any
surgical options for improving the quality of life which is the ultimate goal of
treatment and may occur through achieving amenorrhea or even eumenorrhea
(NICE, 2007).
The indications for surgery for women with AUB include (SOGC, 2013):
 Unresponsiveness to medical therapy.
 Side effects or contraindications for medical therapy.
 Severe anemia.
 Effect on quality of life.
 Associated uterine pathology (large uterine fibroids, endometrial
hyperplasia).
Surgical options include (ACOG, 2013):
 Dilation and curettage.

Uterine artery embolization.
 Hysteroscopic polypectomy.
 Endometrial ablation.
 Myomectomy.

Hysterectomy.
Dilatation and curettage should be done as a primary diagnostic procedure
when endometrial sampling or hysteroscopic evaluation is not possible in cases of
severe acute bleeding refractory to medical therapy (SOGC, 2013).
Uterine artery embolization (UAE) should only be performed for patient
with symptomatic myomas who advised to have surgical treatment. Although,
UAE early results are encouraging, no long-term data is existing. UAE is
-26-
contraindicated in patients with evidence of current genito-urinary infection and/or
malignancy (Gupta et al., 2014).
Myomectomy can
be performed
by laparotomy, laparoscopy, or
hysteroscopy. The choice of surgery route depends on several factors including:
the number, site and size of myomas, the patient age and desire for future fertility
(Puchar et al., 2015).
Hysterectomy is the definitive treatment for AUB. If hysterectomy is
required, the least invasive route should be offered to patients to minimize
morbidity and recovery time; such as, laparoscopic-assisted hysterectomy or
vaginal hysterectomy (Neiboer, 2009).
SPECIAL CONDITIONS FOR AUB:
1. Inherited bleeding disorders:
Abnormal uterine bleeding is one of the most common manifestations of an
inherited bleeding disorder. Up to 84% of patients with Von Willebrand’s disease
are presented with HMB. These conditions should therefore always be considered
on the differential diagnosis for abnormal bleeding (Committee on Adolescent
Health Care; Committee on Gynecologic Practice, 2013).
Von Willebrand’s disease is the most common inherited bleeding disorder,
representing about 70% of cases. Other less common diagnoses include
deficiencies in factor XI, VII, or XIII, carrier status for hemophilia A or B, and
other inherited platelet function abnormalities (AC0G, 2009).
-27-
Despite all patients with AUB should have a CBC including platelet count,
the need for a further coagulation investigation can be determined by a detailed
history. The most important elements of this history include pattern and severity of
the bleeding, past history and family history of bleeding conditions or HMB.
(Sanders et al., 2012). Patients with bleeding disorders may present with different
patterns of uterine bleeding at any age, but the majority will have heavy, regular,
cyclic menstrual cycle since menarche. Up to 50% of adolescents presenting with
severe bleeding at menarche will have a coagulopathy. Irregular or anovulatory
bleeding is almost never caused by hemostatic abnormalities (Rodeghiero, 2008).
Once structural uterine abnormalities have been excluded, initial
investigations
should
include
prothrombin
time
(PT),
activated
partial
thromboplastin time (aPPT), and ferritin when anemia is suspected. Special
investigations for von Willebrand’s disease (factor VIII level, vWF antigen, and
vWF functional assay) can be requested by a family physician or gynecologist, but
interpretation and final diagnoses often require hematological consultation
(Altshuler and Hillard, 2014).
Many of the treatments for HMB used among patients with normal
coagulation can effectively be used among women with bleeding disorders. Regard
to non-hormonal treatment, the exception is NSAIDS, which change platelet
function, thus are contraindicated. Tranexamic acid can be used alone or with any
hormonal treatment method to control menstrual bleeding among these patients
(Weiss, 2012).
Regarding hormonal treatment, the OCP and the LNG-IUS have both been
recorded to decrease menstrual loss specifically among patients with inherited
bleeding disorders (Silva et al., 2013). Also, Injected hormonal agents such as
-28-
DMPA and GnRH agonists can be used for these patients (Altshuler and Hillard,
2014).
If the classical hormonal and non-hormonal treatments of AUB have failed,
specific treatment including Desmopressin or factor replacement can be used.
These treatments should only be considered by the hematologist. Desmopressin,
which releases vWF from platelets, is used to treat bleeding in mild coagulation
disorders. It can be administrated during menstruation intravenously, intranasally,
or subcutaneously. For refractory cases, conservative surgical treatment, including
different methods of endometrial destruction, can effectively and safely be
performed (Leissinger et al., 2014).
Hysterectomy, if needed, must be planned carefully along with a
hematologist (Demer et al., 2005).
2. Adolescent:
Although, the etiology of AUB in adolescence has a similar differential
diagnosis to that of adult women; the relative proportion of causes differs.
According to the PALM- COEIN Classification of AUB, the structural causes
(adenomyosis, leiomyomas) are rare in adolescents (Benette and Gray, 2014).
Abnormal uterine bleeding in adolescents is usually related to an immature
hypothalamic-pituitary-ovarian axis. Within the first year following menarche, up
to 85% of cycles may be anovulatory. The incidence of ovulatory cycles increases
with time from menarche but by the fourth gynecologic year just over half (56%)
will be ovulatory. So, for an adolescent presenting within the first few years of
menarche, a focused history and investigations about the ovarian dysfunction is
often the cause (Deligeoroglou et al., 2013).
-29-
The age at presentation is important when considering causes beyond an
immature hypothalamic-pituitary- ovarian axis. Oligomenorrhea at the age of 15 is
most suspected of persistent cycle irregularity and needs more assessment
(Wilkinson and Kadir, 2010). Adolescents presenting with HMB at or close to
menarche, particularly those who need admission, or blood transfusion, may have a
bleeding disorder in up to 48% of cases (Mullin et al., 2015).
Choice of treatment is based upon the underlying cause, the severity of the
bleeding, and the side effect profile. All medical modalities, both non-hormonal
and hormonal, can be applied safely to adolescents. A significant consideration is
the need for contraception (Mullin et al., 2015).
Combined hormonal contraception is considered an effective first line option
for adolescent patients (Huguelet et al., 2015). Long-acting contraceptives
(injectable progestin, progestin IUS) may be also may be considered as first line
therapies in sexually active adolescents, as well as in non-sexually active
adolescents with personal counseling (Lara-Torre, 2011).
Danazol and GnRH agonists are not typically recommended for adolescents
due to their side effects (Wilkinson and Kadir, 2010).
Hysteroscopy, endometrial ablation, and hysterectomy have no role in the
treatment of AUB in adolescents. Surgical intervention is limited only to the rare
structural abnormality (e.g. polyp or myoma) that requires directed removal
(Huguelet et al., 2015).
-30-
Chapter (2): Endometrial ablation
Endometrial ablation (EA) is a procedure of removing the endometrium for
cessation or decreasing the menstrual cycle in the treatment of AUB in selected
patients who need future fertility. This procedure was indicated to treat HMB
refractory or resistant to medical therapy provided that; not caused by structural
uterine pathology (Bouzari et al., 2014).
HISTORY:
Endometrial ablation can be considered as one of the great success stories in
gynecology. It has changed the treatment of HMB dramatically (Kumar et al.,
2016).
In (1976), Neuwirth described the first operative hysteroscopy which
involved resection of submucos myoma using a modified urological resectoscope.
However, endometrial destruction through the endocervical canal dates back to
1937. Moreover, in (1981), Goldrath described the Laser ablation, but lost its favor
due to the cost and unreliability of the technique. Also, in (1983), DeCherney and
Polan described endometrial ablation by loop electrode and rollerball (RB) using
the electrosurgery via monopolar or bipolar radiofrequency (Zarek and Sharp,
2008).
Since (1990), non-resectoscopic ablation techniques have been developed
using different sources of energy to perform endometrial destruction, including
heated liquid (either free circulating or within a balloon), tissue freezing, and
radiofrequency electricity (Cooper at al., 2011).
-31-
INDICATIONS:
Endometrial ablation is indicated in premenopausal women with HMB but
in the following conditions (ACOG, 2008):
 Intolerance to or failure of medical therapy for AUB.
 No desire for future fertility is needed.
 Refuse or poor surgical fit for hysterectomy.
CONTRAINDICATIONS:
Absolute contraindications to EA include (SOGC, 2015):
 Pregnancy.
 Desire to preserve fertility.
 Known or suspected endometrial hyperplasia or cancer.
 Cervical cancer.
 Active pelvic infection.
 Specific contraindications related to non-resectoscopic techniques.
CAUSES OF FAILURE:
Causes of failure of EA include (Simon et al., 2015):
 Incomplete ablation, missing the upper uterine segment or sparing the
region of cornue.
 Tubal endometriosis
 Prior tubal ligation (entrapped endometrium in Fallopian tubes during
ligation).
 Preoperative dysmenorrhea.
-32-
In a study conducted by (El-Nashar et al, 2009), EA failure was
defined as; persistent bleeding or pain after ablation that may require
reablation or hysterectomy) and its incidence was from 16-30% at 5 years.
Regardless any technique of EA, success rate varies from 73% to
85%. So, repeated ablation or hysterectomy is raised in cases of ablation
failure. The clinical scenario for repeat ablation versus another approach
should be discussed with the patients depending on the surgeon’s skill and
expert. Patient’s consent must be obtained includes complete information,
about possible complications for each scenario (Wortman et al., 2015).
If repeat EA is indicated, a hysteroscopic approach using the
resectoscope is recommended. However, the HydroThermAblator is an
exception for the non- resectoscopic techniques in this condition (Glasser et
al., 2009). The success rates for reablation have been reported to be about
55% to 60% (Wortman et al., 2015).
Complication rates of repeat EA are significantly higher than primary
ablation. In (2008), The American Society Reproductive Medicine (ASRM)
reported that the risks of perforation, more fluid absorption, and bleeding
have been reported to be in the order of 9.3% to 11% versus 2.05% for
primary ablation.
PREOPERATIVE CARE:
I. Counseling:
Patients must be counseled about the expectations outcomes from EA. There
are two main items for counseling:
-33-
1. EA is not a method of sterilization. Patients should be advised for use a
permanent for contraception as severe maternal-fetal complications have
been reported in pregnancies following EA (rupture uterus, fetal limb
defects, and preterm labor) (Lo and Pickersgill, 2006).
2. EA cannot guarantee amenorrhea. The aim of EA is to reduce the blood loss;
amenorrhea, although possible, but cannot be confirmed (Isaacson, 2009).
II. Endometrial preparation:
Endometrial preparation can be considered preoperatively for 2 items;
thinning of the endometrium and the use of prophylactic antibiotics.
1. Endometrial thinning:
A thin endometrium can be achieved if the ablation is done in the first 2 days
of post-menstrual phase, performing curettage before the procedure or
administering of preoperative hormonal drugs; such as: progestogens, Danazol, and
Goserelin (a gonadotropin-releasing hormone analogue, or GnRHa) (Sowter et al.,
2014).
It is well known that endometrial thinning will decrease operating time and
reduce absorption of fluid used for uterine distension. In addition, it may also
improve
the
long-term
outcomes,
including menstrual
blood loss
and
dysmenorrhea. The drawbacks of endometrial thinning are related to hormonal
therapy including their high cost and many side effects (Tan and Lethaby, 2013).
A systematic review suggested that preoperative endometrial thinning using
Goserelin and Danazol resulted in higher rates of amenorrhea at 12 and 24 months
(Tan and Lethaby, 2013).
-34-
In another study conducted by Shawki et al. (2002) using a resectoscopic
EA, amenorrhea rates at 12-month follow-up were 39% for endometrial
preparation with Gn-RH agonists versus 34% for danazol, 26% for
medroxyprogesterone acetate, and 18% for D&C.
Preoperative endometrial thinning will depend on the product monograph for
each individual device. For non-resectoscopic EA, Meta-analysis of a few
randomized trials on second- generation devices (radiofrequency ablation and
balloon devices), reported that no benefits have been achieved with the
pretreatment endometrial thinning. Moreover, side effects were higher when
hormonal therapies were used. On the controversy, for resectoscopic EA,
preoperative endometrial thinning results in higher rates of amenorrhea, decreased
fluid absorption, and shorter operative time (Sowter et al., 2014).
Therefore, endometrial preparation can be used to ease resectoscopic
endometrial ablation (EA) and can be considered for some non-resectoscopic
techniques (Sowter et al., 2014).
2. The use of prophylactic antibiotics:
No randomized control study recommended the routine use of antibiotic
prophylaxis before EA by any technique (Thinkhamrop et al., 2007). Furthermore,
observational data reveal an extremely low risk of infection (ACOG, 2009)
III. Investigations:
There are required investigations prior to EA include (SOGC, 2015):
 Pregnancy test.
 Papanicolaou test within previous 2 years.
-35-
 Cervical cultures if clinically appropriate.
 Endometrial biopsy to exclude endometrial cancer.
 Assessment of uterine cavity for any anomalies or intracavitary pathology
using TVS, SIS, or diagnostic hysteroscopy.
POSTOPERATIVE CARE:
Depending on the type of anesthesia used, patients are usually discharged
within 1 to 3 hours after EA. They can resume their normal activities gradually, but
are advised for (SOGC, 2015):

No sexual intercourse for one week.

Pain management with NSAIDs or opiates, and will usually resolve within
24 hours.

Minimal pinkish discharge or mild vaginal bleeding is usual and can last up
to several weeks following EA.
Patients are instructed for seeking medical advice if they developed any
fever, severe pain, or profuse vaginal bleeding (ASRM, 2008).
Because it is often difficult to estimate the postoperative residual menstrual
discharge and blood, the efficacy of the EA should be assessed at 6 and 12 weeks
postoperatively (ASRM, 2008).
TECHNIQUES:
Endometrial resection/ablation is a method to destroy the basal endometrial
layer to prevent future endometrial proliferation. Tissue destruction to a depth of 4
to 6 mm is needed to destroy this basal endometrial layer (Deb et al., 2008).
-36-
The first-generation techniques (Resectoscopic endometrial ablation) consist
of targeted endometrial destruction under direct hysteroscopic visualization. These
techniques included: laser ablation, electrosurgical endometrial resection by loop
electrode or endometrial ablation by roll-ball (Deb et al., 2008).
Resectoscopic EA offers many advantages. It permits an accurate
assessment of uterine pathology with directed biopsies, documentation with
photography, and concurrent treatment of associated intracavitary pathology. Also,
it can be used in patients who have had previous EA or transmyometrial surgery
(Hopkin et al., 2007).
Despite their effectiveness, the first-generation methods had many
disadvantages include: a requirement for a skilled and expert hysteroscopist, and a
need for an operative room. Also, there have uncommon but serious complications
including uterine perforation and fluid overload (Daniel et al., 2012). So, simpler
alternatives have been established which nominated by; second-generation
techniques (non- resectoscopic ablation) using a different energy sources to destroy
the endometrial lining (Hopkin et al., 2007).
The advantages of the second-generation techniques include: shorter
operative time, needless for a specific training, and they can be done in the
outpatient clinic (without anesthesia). They also help to avoid complications
associated with the use of fluid distention media unlike first generation techniques
while achieving similar results. For these reasons, non-resectoscopic procedures
have become increasing in their popularity (Daniel et al., 2012).
-37-
I.
Resectoscopic EA:
Patients are placed in lithotomy position and the cervix is dilated to at least
10 mm. Most operative hysteroscopic systems involve a 9 mm (27 French) scope.
Hysteroscopes are usually rigid, with using 12, 15, or 30 degrees of angulation.
After uterine distension, the cavity is assessed for any endometrial lesions or
abnormalities. Intrauterine landmarks (tubal ostia, internal cervical os, and/or the
characteristic appearance of the endometrium) should be identified to confirm the
successful entry of the cavity without created a false passage.
Any focal lesions must be biopsied or resected. Endometrial polyps and
small submucos myomas can be removed using the resectoscope; but larger (> 3
cm) myoma, resection will require a skillful and expert hysteroscopist (PerezMedina and Vallejo, 2011).
The uterine walls can be ablated with the ball electrode or resected using the
loop electrode while the rollerball is used exclusively at the fundus and ostial
regions with a light touch technique applying no pressure to avoid their
perforation. The electrode should always be visible, in contact with tissue, and
moving toward the surgeon when activated. The treatment endpoint is a visual
change in the endometrium to a yellow- brown honeycomb appearance which
indicated that myometrial tissue has been reached.
Prolonged activation of the electrode should not be done to prevent
electrosurgical injuries. Also, the ablation beyond the cervico-uterine junction
should be avoided fearing of cervical stenosis (Bradley, 2008).
In (2013), the Advancing Minimally Invasive Gynecology Worldwide
(AAGL) has stated hysteroscopic distention media as shown in table (4):
-38-
Table (4): Types of distention media for hysteroscopy.
1. Electrolytic solutions (Conductive): They are capable of conducting
electricity, therefore cannot be used in conjunction with monopolar electrosurgical
devices. They are recommended only for use in diagnostic cases and in operative
cases in which mechanical, laser and bipolar energy is used. Per AAGL guidelines;
the maximum fluid deficit for a patient should not exceed 2,500 ml.
Normal Saline
Isotonic
Lactated Ringer’s
Isotonic
Protect against hyponatremia but can cause
fluid overload which results in tachypnea,
cerebral and pulmonary odema.
2. Non-electrolytic solutions (Non-conductive): They eliminate problems with
electrical conductivity, but can increase the patient’s risk for hyponatremia and
other specific complications. Use with monopolar energy. Per AAGL guidelines;
the maximum fluid deficit for a patient should not exceed 1,000 ml.
Glucose 5%
Isotonic
Glycine 1.5%
Hypotonic
Dextran 70
Hypertonic
Mannitol 5%
Isotonic
Sorbitol 2.5%-5%
Hypotonic
Mannitol/Sorbitol
mixture (Purisol)
Hypotonic
Contraindicated for patients with glucose
intolerance.
Metabolizes into ammonia and glycol, which
can cross blood brain barrier causing dizziness,
vomiting and coma. Also, may cause transient
decrease in visual acuity and blindness.
Complications include coagulation disorders,
allergic reactions and adult respiratory distress
syndrome (ARDS). Can crystallize on
instruments, obstructing valves and channels.
Has a diuretic effect; may cause hypotension
and circulatory collapse.
Metabolizes to fructose in the liver.
Contraindicated for patients with fructose
intolerance.
Has the both hazards for Sorbitol and Mannitol.
-39-
II.
Non-resectoscopic EA:
Six devices are approved by FDA, using different energy sources for EA.
They are listed in the following:
 Bipolar radiofrequency ablation (NovaSure).
 Cryotherapy (Her Option).
 Heated fluid freely circulated in the uterine cavity (Hydro ThermAblator).
 Fluid contained in a balloon (Thermachoice, Thermablate EAS, and
Cavaterm).
Future technologies such as the Aurora ablation system (radiofrequency
energy and heated Argon gas forming plasma energy) have promising preliminary
results (Sabbah et al., 2011).
For safety and appropriate placement of intracavitary device, intraprocedural
ultrasound
guidance or pre-
and
post-procedural
diagnostic
hysteroscopy can be used. All the above technologies aim to achievement of
coagulation that subsequently will lead to endometrial fibrosis. To obtain the
maximum effect of this aim, 6 months are needed (Penninx et al., 2010).
The choice from second generation technologies depends on the following
(Kroft and liu, 2013):
•
Availability of scientific evidence.
•
Cost effectiveness.
•
Preference of the surgeon.

Safety
-40-
Specifications of each of FDA devices are will be discussed in the
following:
Thermal balloon ablation (ThermaChoice, Thermablate EAS, and Cavaterm):
For the ThermaChoice system (Fig. 2), a single-use silicon balloon-tipped
catheter with a probe-hand piece measuring 5 mm diameter connected via a cable
to a control unit. Within the balloon, the heating element is located, and a separate
port attached to the hand piece permits the administration of 5% dextrose into the
balloon. For activate the device, a minimum pressure of 150 mm Hg must be
achieved; then, the fluid is heated to 87°C. Treatment time is 8 min. Finally, the
balloon is deflated and removed (Sambrook et al., 2014).
For Cavaterm system (Fig. 3), the catheter probe-hand piece measuring 9mm diameter, the fluid used is glycine 1.5%, the temperature is settled at 75°C,
and the treatment time is 15 min (Alaily et al., 2003).
For Thermablate system (EAS) (Fig. 4), the catheter probe-hand piece
measuring 6 mm diameter, the fluid used is glycine 1.5%, the temperature is settled
at 173°C, and the treatment time is 2 min. and 8 seconds (High temperature and
short time) (Mangeshikar et al., 2003).
All types of TBEA cannot be used on women with large or irregular uterine
cavities because the balloon must be in direct contact with the uterine wall to cause
ablation. Cavaterm is contraindicated for women whose uterine cavity is more than
10 cm long (from the internal os to the fundus), and Thermachoice for women
whose uterine cavity is more than 12 cm long, and for those who have a latex
allergy (NICE, 2004).
-41-
Bipolar energy ablation (NovaSure):
The NovaSure (Fig. 5) includes a single-use 7.2-mm probe-hand piece that
is attached to a based control unit. A bipolar mesh electrode is located at the end of
the probe, covered by 2 extendable curved arms. The probe at 27.12 MHz causes
the temperature of the basal endometrial layer to be raised to 50 -55°C allowing
destroying 4-5 mm of the myometrium (Sabbah and Desaulniers, 2006).
The probe is available in different lengths which allow the operator to set
their manually according to the length of uterine cavity (assessed by uterine
sound). In addition, NovaSure insufflates carbon dioxide; as a test for integrity of
uterine cavity. The probe will not be activated automatically, if the cavity failed to
pass this test. Moreover, NovaSure has a closed circuit for suction of any steam
and blood derived, during the ablation phase (Elmardi et al., 2009).
Cryoablation (Her Option):
Her Option (Fig. 6) is the system for cryoablation of the endometrium. It
includes a single-use 4.5-mm OD probe-hand piece which attached via a cable to a
control unit. The probe is introduced in the uterine cavity, and when it is cooled to
the temperature of less than -90°C, an elliptical ice ball will be formed. 2-4
"freeze" sites are typically needed for an optimal result.
This procedure is done under abdominal ultrasonographic guidance. It
allows a visual feedback for accurate treatment of the cavity but, extra personnel is
always required (Dubak et al., 2000).
-42-
Microwave endometrial ablation (MEA) (Microsulis system):
The microwave endometrial ablation device is called “Microsulis” system
(Fig. 7). It includes an 8-mm probe which attached via a cable to a 9.2-GHz, 30-W
control unit. When the device is introduced into the uterine cavity, a tissue
temperature of 95°C at a depth of 6 mm will be achieved. The surgeon must move
the probe from cornu to cornu all endometrium operated. The total treatment time
is 1-4 minutes.
The advantage of this system is that, a marker is located 4 cm from the probe
tip to identify the cervicouterine junction and so, avoid cervical ablation. But, the
disadvantage of this system that; the probe is too large for office use (Downes et
al., 2007).
Fig. 3: Thermachoice system for endometrial ablation.
-43-
Fig. 4: Cavaterm system for endometrial ablation.
Fig. 5: Thermablate system (EAS) for endometrial ablation.
-44-
Fig. 6: Novasure system for endometrial ablation.
Fig. 7: Her Option system for endometrial ablation.
-45-
Fig. 8: Microsulis system for endometrial ablation.
COMPLICATIONS OF ENDOMETRIAL ABLATION
I. Short term complications:
1. Pain, Nausea and vomiting: These are the most common adverse effects
following EA which will generally resolve within 12 to 24 hours of the
procedure (Lethaby et al., 2009).
2. Uterine perforation: It has been reported in 0.3% of non- resectoscopic
EA and 1.3% of resectoscopic ablations. If uterine perforation is done
during cervical dilatation or with the use of resectoscope (without
electrosurgery), EA must be cancelled and the patient should be closely
monitored for signs of intraperitoneal hemorrhage or visceral injury. If the
-46-
perforation occurs while using electrosurgery, abdominal exploration is
mandatory to achieve hemostasis and exclude visceral injury (Sharp,
2012).
3. Perioperative hemorrhage:
It has been reported in 1.2% of non-
resectoscopic ablation and 3.0% of resectoscopic ablation. Immediate
bleeding is usually due to cervical laceration or uterine perforation, while
delayed bleeding is usually due to endometrial sloughing. In cases of late
postoperative bleeding, coagulation studies should be performed especially
if they were not done preoperatively (Lethaby et al., 2009). For acute
hemorrhage, it may be managed with intrauterine Foley balloon tamponade
or intracervical vasopressors injection (Sharp, 2012).
4. Hematometra: This complication has been reported in 0.9% of patients
undergoing non-resectoscopic ablation and in 2.4 % of those undergoing
resectoscopic ablation. Although intrauterine scarring is an aim of EA,
hematometra will occur when endometrial areas are adherent and there is
endometrial bleeding behind these occlusions. Hematometra should be
suspected in a patient with a history of an EA and presents with cyclic
pelvic pain despite of amenorrhea. It can be diagnosed by TVS and can be
prevented by complete ablation of the uterine fundus, cornua, and tubal
ostia and avoiding ablation of the cervico-uterine junction. Cervical
stenosis or even hematometra are managed by hormonal suppression or
cervical dilation with or without hysteroscopic adhesiolysis (SOGC, 2015).
5. Post-ablation tubal sterilization syndrome: The rate of this complication
is high. It has been reported to occur to about 10% after EA especially, in
patients who have undergone tubal ligation prior to EA. The proposed
cause is that bleeding from active endometrium trapped in the uterine
-47-
cornua which can be managed laparoscopically by excision of this tubal
stumps or even hysterectomy (Mehra et al., 2011).
6. Pelvic infections and fever: It occurs in the immediate postoperative
period in approximately 1% of patients who undergone EA. In a metaanalysis, the incidence of these complications included endometritis (1.4 to
2.0%), myometritis (0 to 0.9%), pelvic inflammatory disease (1.1%), and
pelvic abscess (0 to 1.1%) (Sharp et al., 2012).
7. Burn: It may be occurred due to exposure of the vagina or vulva to hot
fluid in hydrothermal ablation or rupture of any thermal balloon (Birdsell,
2010).
8. Complications related to distention media:
There most common
complications are fluid overload (for electrolytic fluid) and hyponatremia
(for non-electrolytic fluid):
A. Fluid overload: It is the main risk when using isotonic, electrolytic
fluid such as, normal saline or Lactated Ringer’s solution which can
be prevented by the following (Darwish et al., 2010):
 Pre-treatment hormonal suppression of the endometrium.
 Adherence to a strict protocol of fluid monitoring must be
considered. Fluid input, output and deficits values must be
reported to the surgeon and anesthesiologist.
 Intracervical injection of pressor drugs (vasopressin,
epinephrine).
 Using a distension pressure less than that of the patient’s
mean arterial pressure.
-48-
Excessive
fluid
absorption
can
be
treated
…………………according to the followings: (SOGC, 2015):
 Excess fluid deficit of 500 cc: The anesthesiologist and
surgeons should be aware about this loss.
 At a fluid deficit of 1000 cc: The procedure should be
completed rapidly as possible. Urinary Foley’s catheter must
be inserted for accurate measurement of urine output, fluid
restriction is obligatory and IV diuretic (e.g. furosemide)
may be used.
 At a fluid deficit of 1500 cc: The procedure should be
cancelled immediately, serum electrolyte values must be
obtained
and
any
abnormalities
will
be
managed
appropriately. Patient should be observed and managed for
signs of fluid overloads such as; tachypnea, pulmonary
edema, changes in level of consciousness, encephalopathy,
and seizure activity.
B. Hyponatremia: It is most common complication resulting from
intravasation of large amounts of non-electrolytic fluid, which
occurs when the ratio between serum sodium and circulating blood
volume dips below normal levels. When intrauterine pressure
exceeds mean arterial pressure, fluid absorption increases
significantly. For every 100 mL absorption of non-electrolyte
solution, serum sodium falls by 1 mEq (Berg et al., 2009).
-49-
Hyponatremia is especially problematic for premenopausal
women, as they are at 25 time’s greater risk for and permanent
brain damage than postmenopausal women. Estrogen and
progesterone in pre-menopausal women inhibits sodium pump
activity, which protects against cerebral edema. This pump serves
to move osmotically-active sodium cations from the brain cells,
thus reducing swelling (Glasser, 2005).
Normal serum sodium is 135 to 145 mEq/L. Serum sodium
less than 135mEq/L can result in hyponatremia which is
categorized as the following (Paschopoulos et al, 2006):
 Mild (130 to 135mEq/L): Changes in mental status;
disorientation, irritability, twitching, nausea, vomiting,
tachypnea.
 Moderate (125 to 130mEq/L): Signs of impending
pulmonary edema; moist skin and mucous membranes,
pitting edema and polyuria.
 Severe (below to 125mEq/L): Vital sign changes including
hypotension and bradycardia, anemia, jaundice, cyanosis,
further encephalopathy hyponatremic encephalopathy (HE).
When serum sodium falls below 115 mEq/L, brain stem
herniation develops in the swelling brain’s attempt to
equalize interstitial and intravascular osmotic pressures.
Permanent brain damage, coma, or even death.
-50-
A panel of United States experts an issued guideline on the
diagnosis, evaluation, and treatment of hyponatremia and
recommended urgent correction by 4-6 mmol/L to prevent brain
herniation and neurological damage from cerebral ischemia. Then,
the correction of acute hyponatremia varies by symptom severity,
as the following (Verbalis et al., 2013):
 Mild to moderate symptoms: 3% NaCl infused at 0.5–2
mL/kg/h.
 Severe symptoms: 100 mL of 3% NaCl infused
intravenously over 10 min. can be repeated up to 3 times.
II. Long term complications:
Recurrent AUB after EA is one of the most common long term
complications. It may be caused by endometrial regeneration, adenomyosis, or
rarely, pre-malignant or malignant condition of the uterus. An endometrial biopsy
should be carried out if more than 1 year has passed since the procedure but,
because of dense intrauterine synechiae which might be developed following EA,
endometrial biopsy may be not possible. In this situation, TVS can be used to
exclude endometrial abnormality. Hysterectomy is indicated for both diagnostic
and therapeutic purposes, if adequate sampling cannot be obtained while ultrasonic
evidence of a thickened endometrium is revealed (Daub et al., 2015).
Pregnancy after EA has been reported. Possible complications include:
spontaneous abortion, preterm labor, premature rupture of membranes, abnormal
placentation, intrauterine growth restrictions and intrauterine fetal death
(McCausland and McCausland, 2007).
-51-
CLINICAL EFFECTIVNESS:
I. EA versus LNG-IUS:
The LNG-IUS is a simple treatment for patients with AUB. It is more costeffective than any surgical technique, including EA. A Cochrane review concluded
that EA and LNG-IUS had similar patient satisfaction, although EA was associated
with more decreasing in the menstrual blood. Importantly, during the first 6
months of its use, LNG- IUS may be associated with progestogenic side effects
including irregular bleeding, breast tenderness, and headache (Kauntiz et al.,
2009).
II. EA versus Hysterectomy:
In a review consists of 9 prospective randomized clinical trials,
hysterectomy was associated with better results regarding pain control and
bleeding (Matteson et al. 2012). In another study with 4 years’ follow-up;
satisfaction rate was 98% of women in the hysterectomy group versus 85% in the
EA group (Munro et al., 2011).
However, hysterectomy was associated with longer hospital stay and a
higher risk of complications. In a retrospective study with 11 years’ follow-up,
stress urinary incontinence and pelvic floor repair associated with EA was lower
than with hysterectomy (Bhattacharya et al., 2011). Also, the costs of EA may be
about half that of hysterectomy in some countries (Longinotti et al., 2008).
-52-
III. THERMAL BALLON VERSUS HYSTEROSCOPIC RESECTION:
National institute for Health and Care Excellence (NICE) released a
guideline on 2004 by the name of “Fluid-filled thermal balloon and microwave
endometrial ablation techniques for heavy menstrual bleeding”. This guideline
included a systemic review comparing the thermal balloon endometrial ablation
(TBEA) and trans-cervical endometrial resection (TCRE) or hysteroscopic roll-ball
ablation (RB) in the treatment of HMB. Eleven studies were included in this
review.
The 1st study was done by Meyer et al. (1998). This study was a randomized
controlled study to compare the clinical efficacy and safety of a TBEA with RB in
the treatment of dysfunctional uterine bleeding. At the beginning of the study, 255
patients were included; 128 for TBEA and 117 for RB but the results were only for
239 patients; 125 for TBEA and 114 for RB. Outcome measures were menstrual
bleeding, pre-menstrual tension syndrome, ability to work outside the home and
patient satisfaction at 0, 3, 6 and 12 months. The authors concluded that; in the
treatment of dysfunctional uterine bleeding, uterine balloon therapy was as
efficacious as hysteroscopic rollerball ablation and may be safer.
The 2nd study was done by Romer (1998). The study was a prospective
randomized trial to compare between Cavaterm balloon coagulation (TBEA)
versus roller-ball endometrium coagulation (RB) as; a therapy of recurrent
menorrhagia. Total number of patients was 20 (10 for TBEA and 10 for RA).
Outcome measure was satisfaction rate. Follow-up was up to 15 months. The
author concluded that; Cavaterm was in comparison to the operative hysteroscopy
as a simple method for endometrial coagulation, and could also be used by
hysteroscopically inexperienced gynecologists with simple technical equipment.
-53-
The 3rd study was done by Gervaise et al. (1999). This study was a
controlled study comparing the clinical efficacy and safety of a thermal uterine
balloon system with hysteroscopic endometrial resection in the treatment of
dysfunctional uterine bleeding. In all, 147 women were treated by two experienced
gynecological surgeons: one performed 73 thermal balloon ablations and the other
74 endometrial resections. Outcome measures were amenorrhea, hypomenorrhea,
eumenorrhea or elimination of dysmenorrhea. Follow up was done between 3-36
months. The authors concluded that; uterine balloon ablation appeared to be as
efficacious as endometrial resection. The former was much easier to perform
especially, by those with limited expertise in hysteroscopic surgery, and thus more
widely applicable and safer.
The 4th study was done by Bonger et al. (2000). This trial was a prospective
cohort study comparing TCRE and hot-fluid balloon ablation in 152 patients
suffering from menorrhagia and not responding to medical treatment. Between
1992 and 1994, all patients (75) had TCRE, whereas from 1995 onward, all
patients (77) had balloon therapy. Outcome measures were surgical re-intervention,
menstrual pattern, and patient satisfaction at 3,6,12 and 24 months. The authors
concluded that; because endometrial ablation with a hot-fluid balloon seems to be
as effective as endometrial resection, with a lower complication rate, balloon
ablation might become the procedure of choice for endometrial ablation.
The 5th study was done by Grainger et al. (2000). This study was a
randomized controlled study to compare the clinical efficacy and safety of a
thermal uterine balloon system (TBEA) with hysteroscopic rollerball ablation (RB)
in the treatment of dysfunctional uterine bleeding. At the beginning of the study,
255 patients were included; 131 for TBEA and 124 for RB but the results were
only 227 patients; 122 for TBEA and 105 for RB. Outcome measures were amount
-54-
of uterine bleeding, secondary complications, and adverse effects. The follow up
was done at 1 week, 3 and 6 months, 1 and 2 years. The authors concluded that;
endometrial ablation by both procedures was highly successful in avoiding
hysterectomy and relieving symptoms of menorrhagia. Additional benefits were
reduction in dysmenorrhea and premenstrual syndrome.
The 6th study was done by Loffer (2001). The study was a
multicenter, prospective, randomized study aiming to compare uterine balloon
therapy (TBEA)
and
hysteroscopic roller-ball endometrial ablation
(RB) with
respect to efficacy and safety in treatment of menorrhagia. Total number of
patients was 255. 131 patients had TBEA and other 124 had RB but, at 3 years data
was only available for 124 patients (114 for TBEA, 100 for RB). Outcome
measures were menstrual flow, menstrual symptoms and adverse effects. The
Follow up was done at 1 week, 2, 6, 12 months and at 2 and 3 years. The authors
concluded
that;
endometrial ablation with
the
ThermaChoice
uterine balloon or rollerball continues at 3 years to be a successful method for
treating menorrhagia, avoiding hysterectomy, decreasing dysmenorrhea and
premenstrual symptoms, and improving quality of life.
The 7th study was done by Soysal et al. (2001). The study was a prospective
randomized trial to compare between endometrial roller ball ablation (RB) and
thermal balloon ablation (TBEA) after pharmacological endometrial thinning.
Total number of patients was 96 (48 for TBEA and 48 for RA). Outcome measures
were blood loss, hemoglobin levels, operating time, pain post operation, future
hysterectomy, amenorrhea, complications and satisfaction. Follow-up was up to 12
months. The authors concluded that; thermal balloon ablation under local
anesthesia for myoma-induced menorrhagia provided significant similar reductions
-55-
in menstrual blood flow and increases in hemoglobin values with no intraoperative
complication compared to roller ball endometrial ablation.
The 8th study was done by Brun (2002). This study was a randomized
controlled trial (RCT) to compare the efficacy and safety of Cavaterm thermal
balloon endometrial ablation with hysteroscopic endometrial resection on 51
patients with menorrhagia unresponsive to medical treatment. 29 patients had
Cavaterm (TBEA), 21 patients had TCRE and 1 patient was lost to follow-up.
Outcome measures were bleeding status, adverse effects and patient satisfaction
after 3 months only. The authors concluded that; Cavaterm thermal balloon
ablation was as effective as hysteroscopic endometrial resection to treat
menorrhagia, both resulting in a significant reduction in menstrual blood loss and
high patient satisfaction.
The 9th study was done by Loffer and Grainger (2002). The study was a
multicenter, prospective, randomized study to compare uterine balloon therapy
(TBEA) and hysteroscopic rollerball endometrial ablation (RB) in the treatment
of menorrhagia. Total number of patients was 402 (202 for TBEA and 200 for
RB). Outcome measures were menstrual status, dysmenorrhea, pelvic pain,
satisfaction. Follow up was extended to 5 years. The authors concluded that;
uterine balloon therapy was effective as, had less complication and of a shorter
operative time than hysteroscopic rollerball ablation in the treatment of
menorrhagia.
The 10th study was done by Pellicano et al. (2002). The study was a
prospective randomized trial to compare the satisfaction rate and the effectiveness
of transcervical hysteroscopic endometrial resection (TCRE) and thermal
destruction of the endometrium in the treatment of menorrhagia (TBEA). Total
-56-
number of patients was 82 (42 for TCRE and 40 for TBEA). Outcome measures
were satisfaction rate, operative time, discharge time, complication rate, reintervention rate, and resumption of normal activity. Follow up was up to 2 years.
The authors concluded that; thermal destruction of the endometrium for the
treatment of menorrhagia should be considered as an effective therapeutic option
because of its acceptability among patients, shorter operative time, and lower blood
loss.
The 11th study was done by Zon-Rabelink et al. (2003). The study was a
prospective randomized trial to compare between two methods of endometrial
ablation, hysteroscopic rollerball electrocoagulation (RB) and non-hysteroscopic
uterine balloon thermal (TBEA) ablation (Thermachoice), regarding intra- and
post-operative technical complications and safety aspects. Total number of patients
was 139 (77 for TBEA and 62 for RA). Outcome measures were intra- and postoperative technical complications and safety aspects. Follow-up was up to 24
months. The authors concluded that; endometrial ablation by uterine balloon
thermal ablation (Thermachoice) was a safe and simple non-hysteroscopic
procedure
In the analysis of this systemic review, the followings had been reported:
 Three TBEA studies reported changes in PBAC score. A study by Meyer et
al. (1998) which compared TBEA with RB, reported that at 12 months, 73%
of the TBEA and 70% of the RB group had normal bleeding levels, defined
as a PBAC score of less than 100. Soysal et al. (2001) reported that 71% of
the TBEA and 79% of the RB group had normal bleeding levels at 12
months, defined by a more criterion (that is, a PBAC score of less than 76).
They reported mean PBAC scores of 41.1 in the TBEA group and 40.2 in
-57-
the RB group. Zon-Rabelink et al. (2003) did not report actual PBAC
scores, but stated that these were significantly better for the TBEA group
than for the RB group at 24 months (p = 0.01), although not at 6 or 12
months. This trial measured treatment success as a post-operative PBAC
score of less than 185. 78% of women in the TBEA group and 76% of
women in the TCRE group achieved this at 24 months.
 At 24 months, between 5% and 8% of patients who had undergone TBEA,
and between 9% and 15% of those who had undergone TCRE or RB, were
still experiencing HMB. At 60 months, these figures were 2% for the TBEA
group and 1% for the TCRE or RB group. No trial reported statistically
significant differences between the groups for recurrent HMB.
 Five TBEA studies by Romer (1998); Meyer et al. (1998); Gervaise et al.
(1999); Bonger et al. (2000); and Soysal et al. (2001) reported amenorrhea
as a clinical outcome. Amenorrhea at 12 months was reported in between
10% and 40% of women for TBEA and between 17% and 30% for
TCRE/RB. These differences were statistically significant in only one study
which was done by Meyer et al. (1998) (14% for TBEA versus 22% for RB,
p < 0.05). At 36 months, 13% of women undergoing TBEA and 21% of
women undergoing RB had amenorrhea, and at 60 months 10% of women
undergoing TBEA and 14% of those undergoing RB had amenorrhea.
 Six TBEA studies reported patient satisfaction. Romer (1998); Meyer et al.
(1998); Zon-Rabelink et al. (2003); Bonger et al. (2000); and Soysal et al.
(2001) reported non- significant differences in patient satisfaction between
TBEA and TCRE and/or RB groups The proportion of women who were
satisfied or very satisfied with the treatment ranged between 79% and 100%
-58-
in TBEA groups, and between 54% and 100% in TCRE and/or RB groups at
12 months. On the contrary, Pellicano et al. (2002) reported statistically
significant differences between the TBEA and the TCRE and/or RB groups.
In this trial, 43% of women undergoing TBEA evaluated the treatment
outcome as 'excellent' at 12 months compared with 24% of women
undergoing TCRE and RB. These figures were 35% and 4% respectively at
24 months.
 The five studies by Meyer et al. (1998); Gervaise et al. (1999); Soysal et al.
(2001); Pellicano et al. (2002); and Zon-Rabelink et al. (2003) consistently
reported shorter procedure times for TBEA compared with TCRE and/or
RB. Of these, the two studies by Meyer et al. (1998) and Gervaise et al.
(1999) reported the percentages of operations that took less than 30 minutes.
For TBEA these percentages were 65% and 100%, and for TCRE and RB
they were 24% and 53% respectively. These differences were significant in
both studies (p < 0.05). The mean operating times were between 11.5 and 24
minutes in the TBEA groups compared with between 37 and 45 minutes in
the TCRE and/or RB groups. The differences were statistically significant in
all studies.
 Six trials reported the proportion of women who required further
intervention. These studies were performed by Meyer et al. (1998); Gervaise
et al. (1999); Bonger et al. (2000); Soysal et al. (2001); Pellicano et al.
(2002); and Zon-Rabelink et al. (2003). At 12 months, between 1% and
10% of women in the TBEA group required further interventions compared
with between 2% and 16% in the TCRE and/or RB groups. In one study by
Pellicano et al. (2002), 5% of women undergoing TBEA and 10% of
-59-
women undergoing TCRE plus RB had had an additional procedure, and
these percentages rose to 6% and 15% respectively at 24 months. This
difference in the repeat surgery rate was statistically significant (p < 0.01).
Meyer et al. (1998) repeat procedures for 15 of the 76 women (19.7%) in the
TBEA group (13 hysterectomies and two repeat ablations), compared with 9
of 71 women (12.7%) in the RB group (seven hysterectomies, two repeat
ablations, and one dilatation and curettage) at 60 months.
Other studies were conducted by many authors:
Singh et al. (2000) carried out a study to evaluate the effectiveness and
safety of a technique for thermal endometrial ablation. The study was carried out in
three steps; step I on 10 fresh uterine specimens, step II on 14 intact uteri during
hysterectomy and step III in 5 patients, two weeks prior to hysterectomy. For the
technique, a Foley catheter No. 14F, which was inflated by a 30 ml 0.09% NaCl
with a temperature of 100°C (boiling) and the fluid was placed inside the uterus for
9 min. Uterine cavity and serosal temperature was recorded during the procedure.
Thermal injury was assessed by gross and histological examination of the
specimens. The mean maximum endometrial cavity temperature was 91 degrees C
whereas serosal temperatures in steps I and II were 34 degrees C and 35.9 degrees
C respectively. None of the balloons ruptured in any of the steps and there were no
complications. In 13 of 14 specimens in step II, there was a zone of hyperemia
with a depth of 3 to 7 mm. The corresponding histological picture was extensive
hemorrhage and fragmentation of glands throughout the endometrium including
the cornual regions. Consistent findings were noted in step III in which all but one
showed extensive coagulative necrosis of the whole of endometrium with edema of
the underlying myometrium. There was a statistically significant positive
-60-
correlation between the volume of fluid injected and depth of hyperemia. The
authors concluded that; this technique could be a simple, effective, inexpensive and
safe alternative to hysteroscopic endometrial ablation.
Brun et al. (2006) carried out a Multicenter randomized trial to compare the
efficacy and safety of Cavaterm thermal balloon endometrial ablation with
hysteroscopic endometrial resection among 51 women with menorrhagia
unresponsive to medical treatment. Amenorrhea rates were 36% and 29% in the
Cavaterm and the endometrial resection groups at 12 months, respectively (ns).
Both treatments significantly reduced uterine bleeding. A subsequent hysterectomy
for recurrent bleeding was performed in 2 women, both previously treated by
resection. The rate of women reporting good or excellent satisfaction was 89% in
the Cavaterm group and 79% in the resection group at 12 months. Discharge time
was significantly lower in women treated by Cavaterm, although postoperative
pain at 1 hour was higher. There were no major complications in either group. The
conclusion was that; Cavaterm thermal balloon ablation was as effective as
hysteroscopic endometrial resection to treat menorrhagia, both resulting in a
significant reduction in menstrual blood loss and high patient satisfaction.
Rishma (2009) conducted a retrospective analysis of 156 women with
dysfunctional uterine bleeding who had completed childbearing and who
underwent uterine balloon ablation therapy using the Thermachoice device to
assess the safety and effectiveness of this technique; as a permanent treatment of
DUB. Regard to results, 49% women had amenorrhea while 41 % had
oligomenorhoea or eumenorrhoea. 90% were satisfied with the procedure. There
were no major complications during this study. The author concluded that;
Thermal balloon endometrial ablation is a simple, safe and effective technique for
the permanent treatment of DUB in well selected case.
-61-
Regarding endometrial ablation by Foley’s catheter, Helal et al. (2010)
conducted a prospective randomized controlled study to assess the efficacy of a
modified Foley's catheter endometrial ablation in the treatment of abnormal uterine
bleeding in low resource settings among 430 premenopausal women. The primary
outcome measure was patient satisfaction regarding menstrual blood loss.
Secondary measures included improvement in quality of life scores and failure
rates. Only 303 patients were available for evaluation at 3-year follow up. 270/303
(89.1%) reported their satisfaction as indicated by reduction in days of menstrual
flow per cycle (4.2 vs. 8.8 days, p < 0.0001). There was a significant improvement
in quality of life scores (p < 0.0001). The rate of failure varies according to the
interval of follow up from 15.6% at 6 months to 10.9% at 3 years. The authors
concluded that; modified Foley's catheter endometrial ablation is a cost effective
alternative to other thermal endometrial ablation techniques in the treatment of
abnormal uterine bleeding in low resource settings.
Another prospective randomized controlled study was performed by Azza
(2012) to assess the efficacy and safety of endometrial thermal ablation by a
technique using Foley’s catheter to treat cases with intractable menorrhagia and to
compare between results with and without pre procedure curettage. Forty eight
patients aged from 39 to 52 years complaining of menorrhagia not responding to
treatment for at least 6 months were included in the study, pre ablation endometrial
curettage was done for 24 randomly selected cases (group 1) and ablation without
curettage for the other 24 cases (group 2). Outcome measures were patient’s
satisfaction, menstrual outcome and hysteroscopic diagnosed scarred endometrium.
This study showed a satisfaction rate of 83.3%, improvement in menstrual bleeding
(79.2%) and hysteroscopic diagnosed scarring of the endometrium (75%). Cases in
group 1 had a significantly higher satisfaction rate (95.8%) than in group 2 (70.8%)
-62-
and significantly lower incidence of persistent menorrhagia after ablation than
cases in group 2 (4.2% versus 37.5%, respectively). Hysteroscopic diagnosed
endometrial scarring was significantly higher in group 1 (91.7%) versus (53.8%)
for group 2. The authors concluded that; endometrial thermal balloon ablation by a
technique using Foley’s catheter was a safe, simple, cheap and effective procedure
as an alternative to hysterectomy for treatment of menorrhagia in properly selected
cases and pre ablation endometrial curettage increased the satisfaction rate and
improved menstrual outcome.
Another randomized clinical prospective comparative study to compare the
efficacy and safety of a uterine thermal balloon system with hysteroscopic
endometrial resection in the treatment of selected cases of menorrhagia was done
by Ashraf and Gamal (2012). In this study, patients were randomized into two
equal groups of 35 patients each. Patients of the first group were treated by uterine
thermal balloon system (35 patients), while those of the other group were treated
by hysteroscopic endometrial resection (35 patients). Quantification of preprocedural and post-procedural menstrual blood was defined by pad count and selfassessment. Twelve-month follow-up data were presented on all women and
compared statistically. The results indicated that both techniques significantly
reduced menstrual blood flow with no clinically significant difference between the
two groups. Success rates, as reflected by percent of patients who returned to
normal bleeding or less, were comparable being 82.8% for the balloon group and
91.4% for the resection group. Procedural time was reduced significantly in the
uterine balloon therapy group. The authors concluded that; uterine thermal balloon
therapy is as efficacious as hysteroscopic resection in the treatment of selected
cases of menorrhagia.
-63-
Also, Naz et al. (2012) conducted a study to determine the efficacy of
modified thermal balloon ablation using Foley’s catheter in the treatment of heavy
menstrual bleeding. This study included 53 patients with heavy menstrual bleeding
between 35 to 45 years of age. Main outcome measures were reduction in
menstrual flow, amenorrhea, minor short term side effects and need of
hysterectomy after failure of procedure. For results: 69% of patients had a
reasonable reduction in menstrual blood flow, 12% had amenorrhea at the end of 6
months of follow up, 18% observed no change in bleeding pattern and underwent
hysterectomy after failure of procedure and 6% patients complained of minor side
effects like abdominal pain and endometritis. The authors concluded that; modified
thermal balloon ablation with Foley’s catheter can be promising conservative
management of heavy menstrual bleeding in resource poor settings.
A brief report was done by (Api and Api, 2012) about using Foley’s catheter
EA on 3 women with severe meno-metrorrhagia unresponsive to medical therapy.
The aim of this report is to evaluate the effectiveness and safety of a new, simple
and money-saving procedure, namely Foley catheter balloon endometrial ablation
(FCBEA), for the treatment of DUB. For the technique, they used a Foley catheter
of a size 18-F which was inflated by a 30 ml 0.09% NaCl with a temperature of
100°C (boiling) and the fluid was placed inside the uterus for 3 minutes for 3 times
(9 min.). All the 3 women were achieved a complete amenorrhea for a 19 months
follow-up period with no procedure-related complications except, a mild persistent
watery discharge for 14-27 days; postoperatively. The authors concluded that;
Foley catheter balloon ablation is a new method of EA, promising, safe and
effective minimal invasive method for the treatment of abnormal uterine bleeding.
A retrospective study by Bouzari et al. (2014) was conducted on 30 patients
with menorrhagia who were unresponsive to hormone therapy or not candidates for
-64-
hysterectomy underwent endometrial ablation using Cavaterm. The aim of this
study was to the analysis of the patient with menorrhagia subjected to operations of
Cavaterm and explores its effectiveness and acceptability. Preoperative and
postoperative PBAC Scoring System was used to assess menorrhagia. Outcome
measures were amenorrhea rates, reduction of menstrual flow rates, and patients'
satisfaction rates at 3, 6 and 12 months postoperative. After the follow-up, 36.7%,
43.3%, and 36.7% of women had a reduction in vaginal bleeding, respectively
while amenorrhea rates were 56.7%, 50.0%, and 56.7%. The rate of women's
reported good or excellent satisfaction was 93.3% in 12 months. During the
follow-up period, no woman received a subsequent hysterectomy. The conclusion
indicated that outcome with the Cavaterm was good for women with menorrhagia.
The authors stated that, it was necessary to emphasize on lower operative and postoperative procedural risk and a deleterious effect on patients who were
unresponsive to hormone therapy.
COST EFFECTIVNESS:
A meta-analysis was done by Kroft and Liu (2013) to assess the economic
effect of the second-generation EA devices compared to first-generation for
treatment of pre-menopausal menorrhagia. After full-text screening, 3 studies were
included in the final qualitative synthesis after met eligibility criteria and (2 studies
comparing first-generation with second-generation and 1 study comparing secondgeneration with second-generation).
The two studies (Garside et al., 2004; Robert et al., 2011) comparing firstgeneration with second- generation devices were both cost-utility studies from
United Kingdom while the single study (Bonger et al. 2005) comparing the
-65-
second- generation with second-generation itself (Novasure vs. Thermachoice)
which was a cost-effectiveness study from Netherlands.
The
first
cost-utility
study
was
performed
by
Garside
et
al.
(2004) comparing the thermal balloon with TCRE, TCRE+rollerball, and rollerball
ablation using a model for a cohort of 1000 patients over a 10-year. The study
found that; the thermal balloon was more cost effectiveness than all three types of
first-generation ablation.
The other cost-utility study was published by Robert et al., (2011) also, on
1000 women over 10 years to compare first-generation with second-generation
ablation devices. This study concluded that; hysterectomy was more cost-effective
than first-generation while the 2nd generation ablation was less cost than
hysterectomy.
SAFETY:
Amso et al. (1998) assessed the safety aspects of thermal balloon therapy,
and found that that up to 16 minutes of therapy can destroy the endometrium and
the submucosal layers. The myometrium is only coagulated to a depth where full
thickness necrosis or injury is unlikely.
A review by Barrow et al. (1999) concluded that thermal balloon is the
safest of all endometrial ablation methods on an outpatient basis. Also, Alestebi
and Eksaknder (1999) did not encounter any complications when performing
endometrial ablation using the thermal balloon.
A multicenter, prospective, randomized study comparing thermal balloon
ablation with endometrial resection for the treatment of AUB by Gervaise et al.
-66-
(1999), reported that; there were minimal postoperative morbidities with no
intraoperative complications.
Another prospective randomized trial on thermal destruction versus
hysteroscopic transcervical endometrial resection for menorrhagia found less intraoperative blood loss and shorter operating time in the thermal destruction group
(Pellicano et al., 2002).
Lok et al. (2002) performed thermal balloon endometrial ablation on 30
women with menorrhagia in an outpatient setting and did not encounter any intraoperative complication. Mangeshikar et al. (2003), Alaily et al. (2003) confirmed
these results.
Ashraf and Gamal (2012) reported intra-operative complications occurred
in 8.5% of the hysteroscopic resection patients, whereas no intra-operative
complications occurred in the thermal balloon group when they compared the
efficacy and safety of a uterine thermal balloon system with hysteroscopic
endometrial resection in the treatment of selected cases of menorrhagia.
Regard to Foley’s catheter endometrial ablation, Azza (2012) and Naz et al.,
(2012) reported minor side effects like abdominal pain and endometritis..
A meta-analysis published by Kroft and Liu (2013) found a decreasing in
the rate of intraoperative and postoperative complications with second-generation
systems compared to first-generation. Also, there was a decreasing in the operating
time by 16.6 minutes, using the second-generation systems. However, there was no
difference between first- and second- generation systems in the incidence of
patients requiring further surgery during the follow-up period.
-67-
Vitagliano et al. (2014) conducted a longitudinal observational study to
evaluate the postoperative pain after thermal balloon ablation for DUB compared
with transcervical endometrial resection. 47 women were included in the study.
They reported that; Pelvic pain was higher 1 and 4 hours after procedure in
thermal balloon ablation group, and patients in the same group required more
analgesic rescue dose. There were no complications such as uterine perforation,
heavy blood loss or thermal injuries with both the procedures. So, the authors
concluded that; TBEA appeared a more painful procedure than TCRE, both in the
immediate postsurgical time and 30 days after surgery.
TREATMENT FAILURE:
Failure of treatment (EA) is defined by persistent of pain or bleeding after
endometrial ablation that need re-ablation or hysterectomy. This definition was
published by El-Nashar et al. (2009) when they conducted a study on 816 patients
underwent endometrial ablation either by radiofrequency device or thermal balloon
ablation. Also the authors described the factors of treatment failure which
included: age before 45 years; parity equal or more than 5; previous tubal ligation;
and history of dysmenorrhea.
-68-
PATIENTS AND METHODS
TYPE OF THE STUDY: A prospective randomized controlled study.
PLACE OF THE STUDY: Obstetrics and Gynecology Department in Benha
university hospital.
DURATION OF THE STUDY: Between January 2014 and December 2015.
AIM OF THE STUDY: To compare the efficacy and safety of hysteroscopic
endometrial ablation (resectoscopic using loop and roll-ball) with nonhysteroscopic technique (Foley’s catheter balloon) in the treatment of menorrhagia
not responding to medical treatment.
INCLUSION CRITERIA: The study included 100 premenopausal patients
complaining of menorrhagia not responding to medical treatment for at least
6 months.
Patients who met entry criteria were randomized to either the hysteroscopy
or the Foley’s catheter group in a 1:1 allocation ratio (50 patients each) by the
generation of a random numbers table.
For quantification of menstrual blood, there are different methods. In our
study, a prospective documentation of bleeding patterns was done by asking the
patients to record menstrual frequency, number of pads used per day, and number
of days of flow per cycle. These data were written in special sheet given to the
patients. Also, side effects and need for further therapy were recorded.
EXCLUSION CRITERIA: They included the followings:
 Patient needs further pregnancy.
-69-
 Uterine depth > 12 cm.
 The presence of uterine scars (previous CS, myomectomy, etc.).
 Any intracavitary pathology as; submucous myoma, polyps or adhesions.
 Endometrial hyperplasia or malignancy.
 Active pelvic inflammatory disease (PID).
 Finally, patients with postmenopausal bleeding.
METHODS: Informed written consent was obtained from all cases, and the
study was approved by the local ethics committee. It was discussed during the
consent process that EA was designed to reduce menstrual flow, not necessarily to
eliminate it.
Endometrial biopsy within the last 6 months is needed to exclude malignant
or a typical lesion in the endometrium.
All cases were subjected to full history taking of mainly menstrual pattern
and severity of bleeding by recording the number of pads per day, duration of
bleeding, presence of blood clots and manifestation of iron deficiency anemia.
Clinical examination (general, abdominal and gynecological) and laboratory
investigations (CBC, kidney function, liver function tests, and coagulation profile)
were done for all patients.
Transvaginal ultrasound (TVS) was done for all cases to rule out any
pathology in uterus or adnexa and to measure endometrial thickness, if there was
any doubt, SIS or diagnostic hysteroscopy was done to exclude uterine cavity
abnormalities and endometrial lesions.
-70-
No pretreatment endometrial thinning regimens were used; however,
ablation was timed to be performed in early follicular phase of the menstrual cycle
(day 4-6).
For all patients, EA was performed under general anesthesia. Prophylactic
antibiotic was given at the start of the procedure. To reduce postoperative pain, all
patients received indomethacin 100 mg rectal suppository immediately after the
procedure.
Technique of thermal balloon endometrial ablation by Foley’s catheter:
1. The patient was draped in the lithotomy position.
2. Sterilization of vulva, vagina and cervix was carefully done using gauze
soaked with povidone iodine solution.
3. Two Simm’s speculums were introduced in into the vagina. The cervix
was grasped with a multiple toothed vollesullum. Uterine sounding was
done. Then, cervical dilation was performed till number 6 Hegar.
4. Foley’s catheter number 18Fr/CH (latex silicon coated, Ultramed) (Fig.
9), with a capacity of 30–50 ml was tested for possible leak and risk of
rupture by inflation of about 20 ml boiling saline then deflation and the
tip of the catheter was cut just above the balloon to allow the inflated
balloon to fit well close to the uterine fundus.
5. The Foley’s catheter was inserted gently into the uterine cavity and
inflated by a variable volume of boiling saline 0.9% as much as the
uterine cavity capacity permits till resistance to add more fluid is reached
under maintained moderate pressure.
-71-
6. For safety, a vaginal gauze pack was placed around the catheter to protect
against accidental balloon leak or rupture.
7. Maintenance of temperature was done by frequent changing of the boiled
saline every 3 minutes by a new boiling saline and the procedure was
continued for 9 minutes then the balloon was deflated and removed.
Fig. 9: Foley’s catheter No. 18 French
Technique of resectoscopic endometrial ablation:
1. The patient was draped in the lithotomy position.
2. Sterilization of vulva, vagina and cervix was carefully done using gauze
soaked with povidone iodine solution.
3. Two Simm’s speculums were introduced in into the vagina. The cervix
was grasped with a multiple toothed vollesullum. Uterine sounding was
done. Then, cervical dilation was performed till number 9 Hegar dilator.
-72-
4. The resectocope elements (passive handle, 4 mm Hopkins II telescope
with an angle 30°, continuous flow outer sheath, and 26 French in the
whole size) (Karl Storz, Germany) were inserted (Fig. 10).
5. Uterine distention was done by the gravity method using a nonconductive, low viscosity solution (Glycine, 1.5 %). The fluid balance
was recorded and monitored continuously.
6. After exclusion of the uterine cavity for any focal lesion, the uterine
walls were ablated using monopolar diathermy by the loop electrode with
the direction of the ablation towards the surgeon when activated.
7. The uterine walls near tubal ostia were ablated using the roll ball (fearing
of increase risk of perforation due to thin endometrium).
8. The procedure endpoint was a visual change in the endometrium to a
yellow- brown honeycomb appearance which indicated that the
myometrial tissue has been reached. Then, the resectoscopic elements
were removed.
Fig. 10: The resectoscope elements.
-73-
For both groups, the operating time was measured from the initiation of
anesthesia to the end of the procedure. Any intra-or postoperative complications
were recorded. Then, the patient was discharged in the same day.
All patients were assessed postoperatively at 3, 6, and 12 months. Follow up
of all patients in the outpatient clinic with a subjective assessment of clinical
outcomes including patients’ satisfaction, menstrual outcome and occurrence of
amenorrhea, hypomenorrhea,
euomenorrhea and persistent or increasing
menorrhagia.
-74-
RESULTS
No patients were lost to follow-up. The demographic data and gynecological
histories of the 100 patients treated either by the Foley’s catheter technique or
hysteroscopic resection demonstrated no significant differences in age, body mass
index (BMI), duration of menorrhagia, pads/cycle, uterine cavity depth, and
position; as shown in table (5).
Table (5): The demographic and gynecological data in study groups
Foley’s catheter group
Hysteroscopic resection group
P
(n=50)
(n=50)
value
Mean
Range
n (%)
(+SD)
Mean
Range
n (%)
(+SD)
Age (years)
46.4 (4.9)
BMI (kg/m2)
30.7 (6.6) 25.2-40.3
32.1 (7.3) 28.1-49.6
NS
9.4 (7.3)
10.4 (7.9)
NS
Years with
40-52
44.6 (5.2)
2-12.0
40-49
NS
1.4-10.4
menorrhagia
Pads/cycle
86 ± 40.4
Uterine cavity
10.4 (1.0)
81 ± 41.7
4.0-10.5
11.1 (1.2)
NS
6.0-12.0
NS
depth (cm)
Uterine
position
(AVF/RVF)
AVF
= 43
(86%)
AVF
= 41
(82%)
NS
RVF
=7
(14%)
-75-
RVF
=9
(18%)
Procedure time was significantly less for the Foley’s catheter group,
compared with mean operative time of in the hysteroscopic resection group
(p<0.05); as shown in table (6).
Intra-operative bleeding indicated by hemoglobin (HB) drop postoperatively was higher among the hysteroscopy group, but the difference was not
significant statically; as shown in table (6).
Hospital stay after operation was longer in hysteroscopy group and it was
statistically significant (p<0.05); as shown in table (6).
Table (6): The operative time (min.), postoperative Hb drop (%) and
hospital stay (Hrs.) in study groups
Foley’s catheter group
(n=50)
Hysteroscopic resection
group (n=50)
Mean (+SD)
Range
Mean (+SD)
Range
Operative time
(min.)
15.5 + 3.5
15-20
30.5+8.6
24-37
<0.05*
Hb drops (%)
0.8 + 0.3
0.2-0.9
1.2+1
0.5-1.6
NS
Hospital stay
(Hrs.)
8 +2
6-10
14+8
8-20
<0.05*
NS= non-significant.
-76-
P
value
There were no intra-operative complications in the Foley’s catheter group.
However, we had 3 intra-operative complications in the hysteroscopy group (6%),
2 cases (4%) with fluid overload, and 1 (2%) patient with cervical lacerations; as
shown in chart (1) and (2).
Postoperatively, 3 cases of endometritis were attributed to the Foley’s
catheter group (6%) and all cases responded to oral antibiotic therapy. For
hysteroscopy group, there were 2 cases (4%) developed endometritis (also,
resolved with oral antibiotics) and 1 case (2%) had a delayed adverse event with
hematometra (resolved with D&C); as shown in chart (1) and (2).
Regard to intra and postoperative complications, there was no statically
significant difference between Foley’s catheter and hysteroscopic resection groups;
as shown in chart (3).
Chart (1): Intra and postoperative complications in Foley's
catheter group
Endometritis
6%
No complication
94%
-77-
Chart (2): Intra and postoperative complications in
hysteroscopic resection group
Endometritis Fluid overload
4%
4%
Hematometra
2%
Cervical laceration
2%
no complication
88%
Chart (3): Intra and postoperative complications in study groups
12%
10%
8%
6%
Hysteroscopic resection
group
4%
Foley"s catheter group
2%
0%
-78-
There was significant reduction in the menstrual flow after treatment as
evidenced by reduction in number of pads/day, days/cycle, and pads/ cycle in both
groups; as shown in tables (7) and (8).
Table (7): Menstrual flow before and after treatment in Foley’s catheter group
Pre treatment
Post treatment
P
value
Mean (+SD)
Range
Mean (+SD)
Range
Pads/day (n=50)
12 + 2.5
6-15
4.5+2.3
0-10
<0.05*
Days/cycle (n=50)
11.2 + 5.7
10-21
4.3+2.3
0-12
<0.05*
Pads/cycle (n=50)
134.4+48
60-224
26.4+20.8
0-72
<0.05*
Table (8): Menstrual flow before and after treatment in resection group
Pre treatment
Post treatment
P
value
Mean (+SD)
Range
Mean (+SD)
Range
Pads/day (n=50)
11.9 + 2.3
6-19
5+1.5
0-11
<0.05*
Days/cycle (n=50)
12.3 + 4.4
9-26
4+2.9
0-10
<0.05*
Pads/cycle (n=50)
143.7 + 50
54-213
24.2+22.8
0-78
<0.05*
-79-
Regard to post treatment menstrual flow changes, although the difference
between both groups was not statistically significant, there was a significant
greater percentage of patients in the hysteroscopy group (40.0%) compared with
the uterine balloon therapy group (20.0%) were amenorrheic at their 12-month
follow up (p<0.05). Percent of patients with hypomenorrhea, eumenorrhea, and
menorrhagia (failed treatment) in both treatment arms of the study were
comparable; as shown in table (9).
The success rates, defined as percent of patients who had eumenorrhea or
less 12 months after treatment, were 86% for the Foley’s catheter group and 92%
for the hysteroscopy group. Success rates were clinically comparable and not
statistically different among the two groups; as shown in table (8).
Table (9): Post treatment pattern in both groups at last visit (12 months)
Foley’s catheter group
(NO. and %)
Hysteroscopic resection
group
P
value
(NO. and %)
Amenorrhea
7 (14%)
14 (28%)
<0.05*
Hypomenorrhea
10 (20%)
9 (18%)
NS
Eumenorrhea
26 (52%)
23 (46%)
NS
Menorrhagia
7 (14%)
4 (8%)
NS
Success rate
43 (86%)
46 (92%)
NS
-80-
Furthermore, repeated measures analysis of variance demonstrated no
difference between the two treatment arms (Foley’s catheter & hysteroscopic
resection group) in bleeding pattern variability at 3, 6, and 12 months after the
procedure; as shown in chart (4) and (5).
Regard to Foley’s catheter group; at 3,6, and 12 months follow up:
Amenorhea was recorded in 5 (10%), 6 (12%) and 7 (14%) patients, respectivly
while hypomenorhea was recorded in 6 (12%), 9 (18%) and 10 (20%) patients,
respectivly. Eumenorrhea was recorded in 34 (68%), 29 (58%) and 26 (52%)
patients, respectivly. Finally, menorrhagia (failed treatment) was recorded in 5
(10%), 7 (14%) and 7 (14%) patients, respectivly; as shown in chart (4).
Chart (4): Changes in the bleeding pattern, over time, after Foley’s catheter
ablation.
60
50
40
menorrhagia
Eumenorrhea
30
Hypomenorrhea
20
Amenorrhea
10
0
3 month
6 month
12 month
-81-
Regard to hysteroscopic resection group; at 3,6, and 12 months follow up:
Amenorhea was recorded in 11 (12%), 13 (15%) and 14 (16%) patients,
respectivly while hypomenorhea was recorded in 8 (16%), 8 (16%) and 9 (18%)
patients, respectivly. Eumenorrhea was recorded in 27 (54%), 25 (50%) and 23
(46%) patients, respectivly. Finally, menorrhagia (failed treatment) was recorded
in 4 (8%) at the all 3 times; as shown in chart (5).
Chart (5): Changes in the bleeding pattern, over time, after hysteroscopic
resection
60
50
40
menorrhagia
30
Eumenorrhea
Hypomenorrhea
20
Amenorrhea
10
0
3 month
6 month
12 month
Treatment failure was occurred in 11% women who suffered from continued
menorrhagia, remaining dissatisfied with their bleeding pattern. The failure rate
was 8% (n = 4) for endometrial resection and 14% (n = 7) for Foley’s catheter
treatment. All these patients were managed surgically by, abdominal hysterectomy.
-82-
DISCUSSION
If medical therapy is unsuccessful in the treatment of DUB, D&C may be
curative but it is only a temporary solution. Although hysterectomy is curative, it
may be associated with a 40% morbidity rate and 10 per 10,000 mortality rate
(Ashraf and Gamal, 2012)
As a result, other surgical intervention for menorrhagia has been developed.
Endometrial ablation is one of the simplest, safest and most promising alternatives
for treatment of menorrhagia in the era of minimal invasive surgery (Singh et al.
2000).
Uterine thermal balloon therapy (TBEA) was developed to simplify the
procedure of EA with an efficacy that parallels to classical hysteroscopic methods
(Singer, 1994). Thermal balloon ablation devices which used are Thermachoice,
Cavaterm and Thermablate systems. Although they are safe, effective and easily
used, they have the disadvantage of being expensive and unavailable in many
centers, so the use of Foley’s catheter balloon in this study was a cheap and
available alternative to these devices. However, Foley’s catheter balloon has the
disadvantage of absence of the control unit which allows proper setting and
monitoring of temperature and pressure, thus the use of this simple technique
should be only used in low resources countries (Azza, 2012).
Failure or success of TBEA is multi factorial; increased age, shorter of
uterine depth and maintaining adequate pressure inside the balloon can predict a
successful treatment. However, the outcome is not affected by parity, uterine
volume and endometrial thickness (Shamash and Sayed, 2004).
-83-
Neuwirth et al. (1994); reported a success rate of 83% used hot 5% dextrose
in a latex balloon.
First generation techniques reported successful results in 61.5-90% of
patients (O’Connor and Magos, 1996; Overton et al. 1997) while TBEA reported
success rate in 80-97% (Meyer et al., 1998; and Feitoza et al. 2003).
Regarding Foley’s catheter ablation, the data obtained by Singh et al.
(2000) were encouraging about its safety and efficacy although the number of
patients was small in their study. Api and Api (2012) confirmed these results in a
brief report in only 3 cases with intractable menorrhagia.
Helal et al. (2010) reported 89.1% of satisfaction in 303 patients when they
conducted a prospective randomized controlled study to assess the efficacy of a
modified Foley's catheter EA in the treatment of AUB in low resource settings; as
indicated by reduction in menstrual flow days per cycle (4.2 Vs. 8.8 days, p <
0.0001). There was a significant improvement in scores of life quality (p < 0.0001).
Another prospective randomized controlled study conducted by, Azza (2012)
to assess the efficacy and safety of EA by a technique using Foley’s catheter to
treat cases with intractable menorrhagia showed a satisfaction rate (83.3%),
improvement in menstrual bleeding (79.2%) and hysteroscopic diagnosed
endometrial scarring (75%).
Also, Naz et al. (2012) conducted a study included 53 patients to determine
the efficacy of EA by Foley’s catheter in the treatment of HMB. They reported that
69% of patients had a reduction in menstrual blood flow and 12% had amenorrhea
at the end of 6 months of follow up. The authors concluded that; EA by Foley’s
catheter had promising results for the conservative management of HMB in low
resource settings.
-84-
For pre-ablation endometrial thinning, Bongers et al. (2002) advised
hormonal suppression drugs or endometrial curettage before thermal ablation; as
they believed that thick endometrium prevents a deep intramural coagulative
effect, thereby limiting to basal layer damage. Azza (2012) agree with this advice;
when she reported a significantly higher satisfaction rate (95.8 vs. 70.8%), a
significantly lower incidence of persistent menorrhagia (4.2% versus 37.5%) and a
significantly higher hysteroscopic diagnosed endometrial scarring (91.7% vs.
53.8%) in patients who underwent pre ablation endometrial curettage than without,
respectively.
On the contrary, this assumption was not confirmed by many
authors (Lissak et al. 2003; and Garza-Leal et al., 2010); as they reported that
endometrial thinning did not affect the outcome of TBEA. Moreover, in a study
performed by Amso et al. (2002, patients who had D&C experienced statistically
more failures which is difficult to explain, and the performance of this procedure
before TBEA can be used only to exclude occult malignancy.
In our study, success of EA was defined as subjective reduction of menses to
eumenorrhea or less. We achieved success rates of 86% and 92% in Foley’s
catheter ablation and the hysteroscopic resection groups respectively which were
not statically different between the 2 groups. Those rates were consistent across 3
occasions of follow up in the first year. Statistically significant differences were
found only between pre-treatment and post-treatment menstrual flow in both
treatments’ arms (p<0.05).
Although, the following studies used another thermal balloon rather than
Foley’s catheter, our results were comparable to those obtained by Meyer et al.
(1998) whom recorded success rates between 80.2% to 84.3% for TBEA and
-85-
hysteroscopic resection groups respectively with significant reduction in menstrual
flow and duration before and after treatment (p<0.0001). The higher success rates
recorded in other studies, reaching up to 97% and the cause might be due to the
longer periods of follow up (3 years) (Singer et al, 1994; Garry, 1995; and
Overton and Maresh, 1995).
In a study conducted by, Brun et al. (2006) using Cavaterm system;
amenorrhea rates were 29% and 36% in the endometrial resection and thermal
balloon groups at 12 months, respectively. Both treatments significantly reduced
menstrual blood loss. The authors concluded that; TBEA was as effective as
hysteroscopic endometrial resection to treat menorrhagia, both resulting in a
significant reduction in menstrual blood loss and high patient satisfaction.
Regard to post treatment menstrual flow changes, we recorded a significant
greater percentage of patients in the hysteroscopy group (40.0%) compared with
the uterine balloon therapy group (20.0%) that were amenorrheic at their 12-month
follow up (p<0.05). However, Percent of patients with hypomenorrhea,
eumenorrhea, and menorrhagia (failed treatment) in both treatment study groups
were comparable. So, postoperative amenorrhea was not a key endpoint because
patients undergoing any form of EA should not predict this result. The main goal
for most menorrhagic women is to be returned to normal menstrual flow or less. If
any patient expecting amenorrhea, she should choose hysterectomy, as this is the
only procedure that can guarantee such a result. Frankly, although amenorrhea
rates were statistically higher among the hysteroscopic ablation patients, no
statistical difference in the results between the two groups as regards
hypomenorrhea or eumenorrhea.
-86-
Treatment failure is defined; as persistent bleeding after procedures. In our
study, 11% women suffered from continued menorrhagia remaining dissatisfied
with their bleeding pattern. The failure rate was 8% (n = 4) for endometrial
resection and 14% (n = 7) for Foley’s catheter treatment. All these patients were
managed surgically by, abdominal hysterectomy. Helal et al. (2010) reported that;
18% of patients had no change in bleeding pattern and underwent hysterectomy
after EA by Foley’s catheter and the failure rate varies according to the interval of
follow up from 15.6% at 6 months to 10.9% at 3 years.
In a study conducted by EL-Nashar et al. (2009), they described predictors
of treatment failure which included: age younger than 45 years; parity of 5 or
greater; previous tubal ligation; and history of dysmenorrhea.
In our study, although the length of post-ablation follow-up was limited to
12 months, such improvements in menstrual bleeding had been achieved in other
studies with 3 years or longer follow up. Ahonkallio et al. (2008) reported that
with a long term follow up (5 years), 76% of patients were satisfied with TBEA
which can be considered as a good result.
Also, in a long follow up study by, Helal et al. (2010), they reported a
reduction in the number of days per cycle and the long term improvement in
dysmenorrhea at 12, 24 and 36 months. At 6 months following this procedure,
18.4% of patients were amenorrheic, 41.6% were hypomenorrhoeic, 14.4% had
spotting and 15.6% reported no improvement and underwent hysterectomy. At 3year follow up, the rate of amenorrhoea, hypomenorrhoea and spotting were 17.2,
37; 20.1%, respectively.
For all patients, general anesthesia was chosen as the method of anesthesia
in our study. This was done to target the operative techniques results to unify the
-87-
inclusion criteria. However, uterine thermal balloon therapy can be done with
paracervical block which is an advantage that may decrease cost and intraoperative complications (Penninx et al., 2009).
In our study, procedure time and hospital stay were significantly less for the
Foley’s catheter group, compared with hysteroscopic resection group. These results
were also agreed with those by Gervaise et al., (1999) and Ashraf and Gamal
(2012).
We recorded intra- operative complications in 6% of hysteroscopic resection
No intra- operative complications were recorded in the balloon group. Delayed
complications were recorded in 6% of patients in both groups. Those figures are
comparable to those of recorded by Meyer et al. (1998.) The American Association
of Laparoscopists reported a complication rate of 4.4% for operative hysteroscopy
(Hulka et al., 2008). Also, Helal et al. (2010) reported that 6% patients
complained of minor side effects like abdominal pain and endometritis after
Foley’s catheter ablation. However, several complication rates ranging from 5 to
10% have been documented (Arieff and Ayus, 1993; Brook et al., 1993; and
Garry et al., 1995).
The pitfall in our study may be the absence of long term follow up, so
several studies with longer follow up are needed to be performed.
-88-
SUMMARY
TYPE OF THE STUDY: A prospective randomized controlled study.
PLACE OF THE STUDY: Obstetrics and Gynecology Department in Benha
university hospital.
DURATION OF THE STUDY: Between January 2014 and December 2015.
AIM OF THE STUDY: To compare the efficacy and safety of hysteroscopic
endometrial ablation (resectoscopic using loop and roll-ball) with nonhysteroscopic technique (Foley’s catheter) in the treatment of menorrhagia not
responding to medical treatment.
INCLUSION CRITERIA: The study included 100 premenopausal patients
complaining of menorrhagia not responding to medical treatment for at least
6 months.
Patients who met entry criteria were randomized to either the hysteroscopy
or the Foley’s catheter group in a 1:1 allocation ratio (50 patients each) by the
generation of a random numbers table.
For menstrual blood quantification, there are several methods. In our study,
a prospective documentation of bleeding patterns was achieved by asking he
patients to report number of pads used per day and number of days of flow per
cycle. These data were written in special sheet forms given to the patients assigned
for trial entry. They were queried as to menstrual volume and frequency, side
effects, and need for further therapy.
-89-
EXCLUSION CRITERIA: They included the followings:
 Patient needs further pregnancy.
 Uterine depth > 12 cm.
 The presence of uterine scars (previous CS, myomectomy, etc.).
 Any pathology distorting the uterine cavity as; submucous fibroids,
intrauterine polyps or adhesions.
 Endometrial hyperplasia or malignancy.
 Active pelvic inflammatory disease (PID).
 Finally, patients with postmenopausal bleeding.
METHODS: Informed written consent was obtained from all cases, and the
study was approved by the local ethics committee. It was emphasized during the
informed consent process that these modalities of treatment were designed to
reduce menstrual flow, not necessarily to eliminate it.
Endometrial biopsy within the last 6 months is needed to exclude malignant
or a typical lesion in the endometrium.
All cases were subjected to full history taking of mainly menstrual pattern
and severity of bleeding by recording the number of pads per day, duration of
bleeding, presence of blood clots and manifestation of iron deficiency anemia.
Clinical examination (general, abdominal and gynecological) and laboratory
investigations (CBC, kidney function, liver function tests, and coagulation profile)
were done for all patients.
Transvaginal ultrasound (TVS) was done for all cases to rule out any
pathology in uterus or adnexa and to measure endometrial thickness, if there was
-90-
any doubt, SIS or diagnostic hysteroscopy was done to exclude uterine cavity
abnormalities and endometrial lesions.
No pretreatment endometrial thinning regimens were used; however,
ablation was timed to be performed in early follicular phase of the menstrual cycle
(day 4-6).
All patients were operated under general anesthesia. Prophylactic antibiotic
was given at the start of the procedure. To reduce postoperative cramping, all
patients received indomethacin 100 mg rectal suppository immediately after the
procedure.
For both groups, the operating time was measured from the initiation of
anesthesia to the end of the procedure. Any intra-or postoperative complications
were recorded. Then, the patient was discharged in the same day.
All patients were assessed postoperatively at 3, 6, and 12 months. Follow up
of all patients in the outpatient clinic with a subjective assessment of clinical
outcomes including patients’ satisfaction, menstrual outcome and occurrence of
amenorrhea, hypomenorrhea, euomenorrhea and persistent or increasing
menorrhagia.
RESULTS: No patients were lost to follow-up. The demographic data and
gynecological histories of the 100 patients treated either by the Foley’s catheter
technique or by hysteroscopic resection demonstrated no significant differences in
age, body mass index (BMI), duration of menorrhagia, pads/cycle, uterine cavity
depth, and position.
Procedure time (min.) and hospital stay (hrs.) was significantly less for the
Foley’s catheter group, compared with hysteroscopic resection group (p<0.05).
-91-
Intra-operative bleeding indicated by hemoglobin (HB) drop post-operatively was
higher among the hysteroscopy group, but the difference was not significant
statically; as the following
Foley’s catheter group
(n=50)
Hysteroscopic resection
group (n=50)
Mean (+SD)
Range
Mean (+SD)
Range
Operative time
(min.)
15.5 + 3.5
15-20
30.5+8.6
24-37
<0.05*
Hb drops (%)
0.8 + 0.3
0.2-0.9
1.2+1
0.5-1.6
NS
Hospital stay
(Hrs.)
8 +2
6-10
14+8
8-20
<0.05*
P
value
There were no intra-operative complications in the Foley’s catheter group.
However, we had 3 intra-operative complications in the hysteroscopy group (6%),
2 cases (4%) with fluid overload, and 1 (2%) patient with cervical lacerations.
Postoperatively, 3 cases of endometritis were attributed to the Foley’s
catheter group (6%) and all cases responded to oral antibiotic therapy. For
hysteroscopy group, there were 2 cases (4%) developed endometritis (also,
resolved with oral antibiotics) and 1 case (2%) had a delayed adverse event with
hematometra (resolved with D&C).
Regard to the intra and postoperative complications, there was no statically
significant difference on patients who underwent Foley’s catheter ablation or
hysteroscopic resection.
-92-
There was significant reduction in the menstrual flow after treatment as
evidenced by reduction in number of pads/day, days/cycle, and pads/ cycle in
Foley’s catheter group; as the following:
Pre treatment
Post treatment
P
value
Mean (+SD)
Range
Mean (+SD)
Range
Pads/day (n=50)
12 + 2.5
6-15
4.5+2.3
0-10
<0.05*
Days/cycle (n=50)
11.2 + 5.7
10-21
4.3+2.3
0-12
<0.05*
Pads/cycle (n=50)
134.4+48
60-224
26.4+20.8
0-72
<0.05*
Also, there was significant reduction in the menstrual flow after treatment as
evidenced by reduction in number of pads/day, days/cycle, and pads/ cycle in
Foley’s catheter group; as the following:
Pre treatment
Post treatment
P
value
Mean (+SD)
Range
Mean (+SD)
Range
Pads/day (n=50)
11.9 + 2.3
6-19
5+1.5
0-11
<0.05*
Days/cycle (n=50)
12.3 + 4.4
9-26
4+2.9
0-10
<0.05*
Pads/cycle (n=50)
143.7 + 50
54-213
24.2+22.8
0-78
<0.05*
-93-
Regard to post treatment menstrual flow changes, although the difference
between both groups was not statistically significant, there was a significant
greater percentage of patients in the hysteroscopy group (40.0%) compared with
the uterine balloon therapy group (20.0%) were amenorrheic at their 12-month
follow up (p<0.05). Percent of patients with hypomenorrhea, eumenorrhea, and
menorrhagia (failed treatment) in both treatment arms of the study were
comparable.
The success rate was defined as percent of patients who had eumenorrhea or
less 12 months after treatment. This rate was 86% for the Foley’s catheter group
and 92% for the hysteroscopy group. Success rates were clinically comparable and
not statistically different among the two groups; as the following:
Foley’s catheter group
(NO. and %)
Hysteroscopic resection
group
P
value
(NO. and %)
Amenorrhea
7 (14%)
14 (28%)
<0.05*
Hypomenorrhea
10 (20%)
9 (18%)
NS
Eumenorrhea
26 (52%)
23 (46%)
NS
Menorrhagia
7 (14%)
4 (8%)
NS
Success rate
43 (86%)
46 (92%)
NS
Furthermore, repeated measures analysis of variance demonstrated no
difference between the two treatment arms (Foley’s catheter & hysteroscopic
-94-
resection group) in bleeding pattern variability at 3, 6, and 12 months after the
procedure.
Regard to Foley’s catheter group; at 3,6, and 12 months follow up:
Amenorhea was recorded in 5 (10%), 6 (12%) and 7 (14%) patients, respectivly
while hypomenorhea was recorded in 6 (12%), 9 (18%) and 10 (20%) patients,
respectivly. Eumenorrhea was recorded in 34 (68%), 29 (58%) and 26 (52%)
patients, respectivly. Finally, menorrhagia (failed treatment) was recorded in 5
(10%), 7 (14%) and 7 (14%) patients, respectivly. These results were demonstrated
in the following charts:
60
50
40
menorrhagia
Eumenorrhea
30
Hypomenorrhea
20
Amenorrhea
10
0
3 month
6 month
12 month
Regard to hysteroscopic resection group; at 3,6, and 12 months follow up:
Amenorhea was recorded in 11 (12%), 13 (15%) and 14 (16%) patients,
respectivly while hypomenorhea was recorded in 8 (16%), 8 (16%) and 9 (18%)
patients, respectivly. Eumenorrhea was recorded in 27 (54%), 25 (50%) and 23
-95-
(46%) patients, respectivly. Finally, menorrhagia (failed treatment) was recorded
in 4 (8%) at the all 3 times. The results were demonstrated in the following charts:
60
50
40
menorrhagia
30
Eumenorrhea
Hypomenorrhea
20
Amenorrhea
10
0
3 month
6 month
12 month
Treatment failure was occurred in 11% women who suffered from continued
menorrhagia, remaining dissatisfied with their bleeding pattern. The failure rate
was 8% (n = 4) for endometrial resection and 14% (n = 7) for Foley’s catheter
treatment. All these patients were managed surgically by, abdominal hysterectomy.
-96-
COCLUSIONS AND RECOMMENDATIONS
 Foley's catheter endometrial ablation is as efficacious as to hysteroscopic
resection in the treatment of persistent menorrhagia (failed medical
treatment). It has similar results, easy, simple and need no experience.
 Large series studies and evaluation of clinical response for a longer period
are advised to be performed. The pitfall in our study is the small number of
cases (100) and absence of long term follow up (only 12 months).
-97-
REFERENCES
Advancing
Minimally
Invasive
AAGL Practice Report:
Gynecology
Practice
Guidelines
Worldwide
(AAGL).
for the Management of
Hysteroscopic Distention Media: (Replaces Hysteroscopic Fluid Monitoring
Guidelines. J Am Assoc Gynecok Laparosc. 2000; 7:167-168.). J Minim
Invasive Gynecol. 2013; 20:137-48.
Ahonkallio S, Martikainen S and Santala M. Endometrial thermal balloon
ablation has a beneficial long-term effect on menorrhagia. Acta Obstet
Gynecol. 2008; 87:107-10.
Alaily AB Auld BJ and DiabY. Endometrial ablation with the Cavaterm balloon.
J Obstet Gynaecol. 2003; :231:51-54.
Alestebi FA and Ekskander VG. Thermal balloon endometrial ablation to treat
menorrhagia in high risk surgical candidates. J Am Assoc Gynecol
Laparosc. 1999; 6:4:435-9.
Altshuler AL and Hillard PJ. Menstrual suppression for adolescents. Curr Opin
Obstet Gynecol. 2014; 26:323-31.
American College of Obstetricians and Gynecologists (ACOG). ACOG practice
bulletin No. 104: antibiotic prophylaxis for gynecologic procedures. Obstet
Gynecol. 2009 May. 113(5):1180-9.
American College of Obstetricians and Gynecologists (ACOG). ACOG
committee
opinion
no.
557:
Management
-98-
of acute abnormal uterine
bleeding in non-pregnant reproductive-aged women. Obstet Gynecol. 2013;
121:891-6.
American College of Obstetricians and Gynecologists (ACOG). Committee on
Adolescent Health Care; American College of Obstetricians and
Gynecologists Committee Gynecologic Practice. ACOG Committee Opinion
No. 451: Von Willebrand’s disease in women. Obstet Gynecol
2009:114:1439-43.
American Society for Reproductive Medicine (ASRM). Indications and options
for endometrial ablation. Fertil Steril 2008; 90: 237-240.
Amso NN, Stabinsky S and McFaul. J Am Assoc Gynecol Laparosc. 2002,
9:429-35.
Api M and Api O. Foley catheter balloon endometrial ablation: successful
treatment of three cases. J Pak Med Assoc. 2012; 62;3:284-6.
Arieff AL and Ayus JC. Endometrial ablation complicated by fatal hyponatremic
encephalopathy. JAMA. 1993; 270:1230-32.
Ashraf TA and Gamal M. Uterine thermal balloon ablation versus hysteroscopic
endometrial resection in treatment of menorrhagia. Gynecol Obstet. 2012;
2:136.
Azza
A. Endometrial thermal balloon ablation by a simple technique using
Foley’s catheter with or without pre ablation endometrial curettage to treat
cases with intractable menorrhagia. MEFS. 2012; 17:116-21.
Barrow C. Ballon ‘Endometrial ablation as a safe alternative to hysterectomy’.
AORN J. 1999; 80:83-6.
-99-
Bennett AR
and Gray SH. What to do when she's bleeding through: the
recognition, evaluation, and management of abnormal uterine bleeding in
adolescents. Curr Opin Pediatr. 2014; 26:413-9.
Berg A, Sandvik L, Langebrekke A and Istre O. A randomized trial comparing
monopolar electrodes using glycine 1.5% with two different types of bipolar
electrodes (TCRis, Versapoint) using saline, in hysteroscopic surgery. Fertil
Steril. 2009; 91:1273-8.
Bhattacharya S, Middleton LJ, Tsourapas A, Lee AJ, Champaneria R,
Daniels JP and et al. Hysterectomy, endometrial ablation and Mirena® for
heavy menstrual bleeding: a systematic review of clinical effectiveness and
cost- effectiveness analysis. Health Technol Assess. 2011; 15:iii–xvi–1-252.
Birdsell DC, Mattatall F, Rosengarten AM and Watson SD. Vulvar burn: a
complication of hysteroscopic endometrial ablation. J Obstet Gynaecol Can.
2010; 32:1021-2.
Bongers MY, Mol BW and Brolmann HA. Prognostic factors for the success of
thermal balloon ablation in the treatment of menorrhagia. Obstet
Gynecol. 2002; 99:6:1060-66.
Bongers MY, Mol BW, Dijkhuizen FP and Brolmann HA. Is balloon ablation
as effective as endometrial electroresection in the treatment of menorrhagia?
J Laparoendosc Adv Surg Tech A. 2000; 10:85–92.
Bongers MY, Van Der Bourdrez P, Steeg JW, Heintz A, Brolmann H, and
Mol BJ. Thermal endometrial ablation in dysfunctional uterine bleeding: an
economic comparison of bipolar ablation and balloon ablation. Gynecol
Surg. 2005; 2:271-77.
-100-
Bouzari Z, Yazdani S, Azimi S and Delavar M. Thermal Balloon Endometrial
Ablation in the Treatment of Heavy Menstrual Bleeding. Med Arch 2014;
68: 411-13.
Bouzari Z, Yazdani S, Azimi S and Delavar M. Thermal Balloon Endometrial
Ablation in the Treatment of Heavy Menstrual Bleeding. Med Arch. 2014;
68:6:411-13.
Bradley LD and Gueye NA. The medical management of abnormal uterine
bleeding in reproductive-aged women. Am J Obstet Gynecol. 2016; 214:3144.
Bradley LD. Hysteroscopy: Office Evaluation and Management of The Uterine
Cavity. Linda D. Bradley and Tommaso Falconi (editors). MOSBY
ELSEVIER (Publisher). 1st edition. 2008; 18:201-22.
Brooks PG, Clouse J and Morris LS. Hysterectomy vs. resectoscopic
endometrial ablation for the control of abnormal uterine bleeding. A costcomparative study. J Reprod Med. 1994; 39:55-60.
Brun JL. French randomised comparative multicentre study of Cavaterm™ versus
resection in patients with meorrhagia: interim results. Morges, Switzerland:
Wallsten Medical SA; 2002.
Cirilli AR and Cipot SJ. Emergency evaluation and management of
vaginal bleeding in the nonpregnant patient. Emerg Med Clin North
Am. 2012; 30:991-1006.
Committee on Adolescent Health Care and Committee on Gynecologic
Practice. Committee Opinion No.580: von Willebrand’s disease in women.
Obstet Gynecol. 2013; 122:1368-73.
-101-
Cooper K, Lee A, Chien P, Raja E, Timmaraju V and Bhattacharya S.
Outcomes following hysterectomy or endometrial ablation for heavy
menstrual bleeding: retrospective analysis of hospital episode statistics in
Scotland. BJOG. 2011; 118(10):1171–9.
Darwish AM, Hassan ZZ, Attia AM, Abdelraheem SS and Ahmed YM.
Biological effects of distension media in bipolar versus monopolar
resectoscopic myomectomy: a randomized trial. J Obstet Gynaecol Res.
2010; 36:810-17.
Daub CA, Sepmeyer JA, Hathuc V, Sakala MD, Caserta MP, Clingan MJ and
et al. Endometrial Ablation: Normal Imaging Appearance and Delayed
Complications. AJR Am J Roentgenol. 2015; 205:451-60.
Deb S, Flora K AND Atiomo W. A survey of preferences and practices of
endometrial ablation/resection for menorrhagia in the United Kingdom.
Fertil Steril 2008; 90:1812-7.
DeCherney A, Polan ML. Hysteroscopic management of intrauterine lesions and
intractable uterine bleeding. Obstet Gynecol. 1983; 61:392-97.
Deligeoroglou E, Karountzos V and Creatsas G. Abnormal uterine bleeding and
dysfunctional uterine bleeding in pediatric and adolescent gynecology.
Gynecol Endocrinol. 2013; 29:74-8.
Demers C, Derzko C, David M, Douglas J; Society of Obstetricians and
Gynecologists of Canada. Gynaecological and obstetric management of
women with inherited bleeding disorders. SOGC Clinical Practice
Guidelines, No 163, July 2005. J Obstet Gynaecol Can 2005; 27:707-32.
-102-
Dobak
JD, Willems
J, Howard
Endometrial cryoablation with
R, Shea
C
ultrasound
and
Townsend
visualization
in
DE.
women
undergoing hysterectomy. J Am Assoc Gynecol Laparosc. 2000; 7:1:89-93.
Downes E, Yasmin R and Flemming R. Microwave endometrial ablation:
development and clinical application. Surg Technol Int. 2007; 16:142-6.
Dutton C, Ackerson L and Phelps-Sandall B. Outcomes after rollerball
endometrial ablation for menorrhagia.Obstet Gynecol. 2001; 98;1:35-39.
Elmardi
A, Furara
S, Khan
F
and
Hamza
M.
NovaSure impedance
controlled system for endometrial ablation: the experience of the first UK
reference centre. J Obstet Gynaecol. 2009; 29:5:419-22.
El-Nashar SA, Hopkins MR and Creedon DJ. Prediction of treatment outcomes
after global endometrial ablation. Obstet Gynecol. 2009; 113:97-106.
Farquhar C and Brown J. Oral contraceptive pill for heavy menstrual bleeding.
Cochrane Database Syst Rev. 2009; 4:2.
Feitoza S, Gebhart J, Gostout B, Wilson B and Cliby W. Efficacy of thermal
balloon ablation in patients with abnormal uterine bleeding. Am J Obstet
Gynaecol. 2003; 189:453-57.
Frick KD, Clark MA, Steinwachs DM, Langenberg P, Stovall D, Munro MG
and et al. Financial and quality-of-life burden of dysfunctional uterine
bleeding among women agreeing to obtain surgical treatment. Women’s
Health Issues 2009; 19:70-78.
-103-
Gannon MJ, Day P, Hammadieh N and Johnson N. A new method for
measuring menstrual blood loss and its use in screening women before
endometrial ablation. Br J Obstet Gynaecol. 1996; 103:1029-33.
Garry R, Shelley-Jones D, Mooney P and Phillips G. Six hundred endometrial
laser ablations. Obstet Gynecol. 1995; 85:24-9.
Garside R, Stein K, Wyatt K, Round A and Pitt MA. Cost-utility analysis of
microwave and thermal balloon endometrial ablation techniques for the
treatment of heavy menstrual bleeding. BJOG. 2004; 111:1103-14.
Garza-leal G, Pena A, Donovan A, Cash C, Romanowski C, Ilie B and et al.
Clinical evaluation of a third generation thermal uterine balloon therapy
system for menorrhagia coupled with curettage. J Minimally Invasive
Gynecol. 2010; 1:82-90.
Gervaise A, Fernandez H, Capella-Allouc S, Taylor S, La Vieille S, Hamou J
and et al. Thermal balloon ablation versus endometrial resection for the
treatment of abnormal uterine bleeding. Hum Reprod.1999; 14:2743-7.
Glasser M. Hysteroscopy: Managing and minimizing operative complications.
OBG Management. 2005; 17:42-57.
Glasser MH, Heinlein PK and Hung Y-Y. Office endometrial ablation with local
anaesthesia using the HydroThermAblator system: comparison of outcomes
in patients with submucous myomas with those with normal cavities. J
Minim Invasive Gynecol 2009; 16:700-7.
Gokyildiz S, Aslan E, Beji K, and Mecdi M. The Effects of Menorrhagia on
Women’s Quality of Life: A Case-Control Study. ISRN Obstetrics and
Gynecology.2013; 2013:7.
-104-
Grainger DA, Tjaden BL, Rowland C and Meyer WR. Thermal balloon and
rollerball ablation to treat menorrhagia: two-year results of a multicenter,
prospective, randomized, clinical trial. J Am Assoc Gynecol Laparosc. 2000;
7:175-9.
Gupta JK, Sinha A, Lumsden MA and Hickey M. Uterine artery embolization
for symptomatic uterine fibroids. Cochrane Database Syst Rev. 2014; 12:5073.
Hallberg L and Nilsson L. Determination of menstrual blood loss. Scand J Clin
Lab Invest. 1964; 16:244-8.
Hansen BB, Dreisler E and Stampe Sørensen S. Outcome of repeated
hysteroscopic resection of the endometrium. J Minim Invasive Gynecol
2008; 15:704–6.
Hawe J, Abbot J and Hunter D.
A randomized controlled comparing the
Cavaterm endometrial ablation system with the ND:YAG laser for the
treatment of dysfunctional uterine bleeding. BJOG. 2003;110:4:350-57.
Higham JM, O’Brien PMS and Shaw RW. Assessment of menstrual blood loss
using a pictorial chart. Br J Obstet Gynaecol. 1990; 97:734-9.
Hopkins MR, Creedon DJ, El-Nashar SA, Brown DL, Good AE and
Famuyide AO. Radiofrequency global endometrial ablation followed by
hysteroscopic sterilization. J Minim Invasive Gynecol. 2007; 14:494-501.
Huang GS, Gebb JS, Einstein MH, Shahabi S, Novetsky AP and Goldberg
GL. Accuracy of preoperative endometrial sampling for the detection of
high-grade endometrial tumors. Am J Obstet Gynecol 2007; 196:243.
-105-
Huguelet PS, Buyers EM, Lange-Liss JH and Scott SM. Treatment of
acute abnormal uterine bleeding in adolescents: what are providers doing in
various specialties?. J Pediatr Adolesc Gynecol. 2015; 15:1083-88.
Hulka JF, Peterson HA, Phillips JM and Surrey MW. Operative hysteroscopy:
American Association of Gynecologic Laparoscopists’ 1993 Membership
Survey. J Am Assoc Gynecol Laparosc. 2008; 2:131-32.
Janssen CA, Scholten PC and Heintz AP. A simple visual assessment technique
to discriminate between menorrhagia and normal menstrual blood loss.
Obstet Gynecol. 1995; 85:977-82.
Kaunitz AM, Meredith S, Inki P, Kubba A, Sanchez-Ramos L. Levonorgestrelreleasing intrauterine system and endometrial ablation in heavy menstrual
bleeding: a systematic review and meta-analysis. Obstet Gynecol 2009;
113:1104–16.
Khrouf M and Khaled T. Diagnosis and Management of Formerly Called
“Dysfunctional Uterine Bleeding” According to PALM-COEIN FIGO
Classification and the New Guidelines. J Obstet Gynaecol India. 2014; 64:
388-93.
Kotdawala P, Kotdawala S, and Nagar N. Evaluation of endometrium in perimenopausal abnormal uterine bleeding J Midlife Health. 2013; 4:16-21.
Kroft J and Liu G. First- versus second-generation endometrial ablation devices
for treatment of menorrhagia: a systematic review, meta-analysis and
appraisal of economic evaluations. J Obstet Gynaecol Can. 2013; 35:1010-9.
Kumar V, Chodankar R, Gupta JK. Endometrial ablation for heavy menstrual
bleeding. Womens Health (Lond Engl) 2016; 12:45-52.
-106-
La Sala GB, Blasi I and Gallinelli A. Diagnostic accuracy of sonohysterography
and transvaginal sonography as compared with hysteroscopy and
endometrial biopsy: a prospective study. Minerva Ginecol 2011; 63:421.
Lacey JV, Sherman ME, Rush BB, Ronnett BM, Ioffe OB, Duggan MA and et
al. Absolute risk of endometrial carcinoma during 20-year follow-up among
women with endometrial hyperplasia. J Clin Oncol 2010; 28:788-9.
Lara-Torre E, Spotswood L, Correia N and Weiss PM. Intrauterine
contraception in adolescents and young women: a descriptive study of use,
side effects, and compliance. J Pediatr Adolesc Gynecol 2011; 24:39-41.
Leissinger C, Carcao M, Gill JC, Journeycake J, Singleton T and Valentino L.
Desmopressin
(DDAVP)
in
the
management
of
patients
with
congenital bleeding disorders. Haemophilia. 2014; 20:158-67.
Lethaby A, Augwood C, Duckitt K and Farquhar C. Nonsteroidal antiinflammatory drugs for heavy menstrual bleeding. Cochrane Database Syst
Rev 2007; 4:4.
Lissak A, Fruchter O and Mashiach S. Immediate versus delayed treatment of
perimenopausal bleeding due to benign causes by thermal balloon ablation. J
Am Assoc Gynecol Laparosc. 1999; 2:145-50.
Loffer FD and Grainger D. Five-year follow-up of patients participating in a
randomized trial of uterine balloon therapy versus rollerball ablation for
treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 2002; 9:429-35.
Loffer FD. Three-year comparison of thermal balloon and rollerball ablation in
treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 2001; 8:48-54.
-107-
Lok IH, Chan M and Tam WH. Patient-controlled sedation for outpatient
thermal balloon endometrial ablation. J Am Assoc Gynecol Lapparosc.
2002; 9:4:436-41.
Longinotti MK, Jacobson GF, Hung Y-Y and Learman LA. Probability of
hysterectomy after endometrial ablation. Obstet Gynecol 2008; 112:1214-20.
Magos AL, Baumann R, Turnbull AC. Transcervical resection of endometrium
in women with menorrhagia. BMJ 1989; 298:1209-12.
Mangeshikar PS, Kapur A and Yackel DB. Endometrial ablation with a new
thermal balloon system. J Am Assoc Gynecol Lapparosc. 2003; 10:1:27-32.
Matteson KA, Abed H, Wheeler TL, Sung VW, Rahn DD, Schaffer JI and et
al. A systematic review comparing hysterectomy with less-invasive
treatments for abnormal uterine bleeding. J Minim Invasive Gynecol 2012;
19:13-28.
McCausland AM and McCausland VM. Long-term complications of
endometrial ablation: cause, diagnosis, treatment, and prevention. J Minim
Invasive Gynecol. 2007; 14:399-406.
Mehra
N, Farshid
S, Lamba
M
and
Singh
SS.
Post-ablation tubal
sterilization syndrome. J Obstet Gynaecol Can. 2011; 33:1085.
Meyer WR, Walsh BW, Grainger DA, Peacock LM, Loffer FD and Steege JF.
Thermal balloon and rollerball ablation to treat menorrhagia: a multicenter
comparison. Obstet Gynecol. 1998; 92:98-103.
Middleton LJ, Champaneria R, Daniels JP, Bhattacharya S, Cooper KG,
Hilken NH and et al. Hysterectomy, endometrial destruction, and
-108-
levonorgestrel releasing intrauterine system (Mirena) for heavy menstrual
bleeding: systematic review and meta-analysis of data from individual
patients. BMJ 2010; 341:c3929.
Mullins TL, Miller RJ and Mullins ES. Evaluation and Management of
Adolescents with Abnormal Uterine Bleeding. Pediatr Ann. 2015; 44:21822.
Munro MG, Dickersin K, Clark MA, Langenberg P, Scherer RW, Frick KD
and et al. The Surgical Treatments Outcomes Project for Dysfunctional
Uterine Bleeding: summary of an Agency for Health Research and Qualitysponsored randomized trial of endometrial ablation versus hysterectomy for
women with heavy menstrual bleeding. Menopause 2011; 18:445-52.
Munro MG, Critchley HO, Broder MS, Fraser IS; FIGO Working Group on
Menstrual Disorders. FIGO classification system (PALM-COEIN) for
causes of abnormal uterine bleeding in nongravid women of reproductive
age. Int J Gynaecol Obstet. 2011; 113:3-13.
Munro MG.
Abnormal uterine bleeding. Cambridge: Cambridge University
Press; 2010.
National Institute for Health and Clinical Excellence (NICE). Clinical
guideline CG78: Fluid-filled thermal balloon and microwave endometrial
ablation techniques for heavy menstrual bleeding.. 2004; 78:1-31.
National Institute for Health and Clinical Excellence (NICE). Clinical
guideline CG44: heavy menstrual bleeding. London: Royal College of
Obstetricians and Gynecologists. 2007; 15:7.
-109-
Naz M, Irshad F, Zafar H, Fatima U. Efficacy of modified thermal balloon
ablation in heavy menstrual bleeding. JUMDC. 2012; 3:2:1-5.
Neuwirth R, Duran M, Singer A, MacDonald R and Bolduc L. The endometrial
ablator: A new instrument. Obstet Gynecol. 1994; 3:792-96.
Nieboer TE, Johnson N, Lethaby A, Tavender E, Curr E, Garry R and et al.
Surgical approach to hysterectomy for benign gynaecological disease.
Cochrane Database Syst Rev 2009; 3:36-72.
O’Connor H and Magos A. Endometrial resection for the treatment of
menorrhagia. N Engl J Med. 1996; 335:151-56.
Overton C, Hargreaves J and Maresh M. A national survey of the complications
of endometrial destruction for menstrual disorders: the MISTLETOE study
Minimally Invasive Surgical Techniques – Laser, EndoThermal or
Endoresection. Br J Obstet Gynaecol. 1997; 104:1351-39.
Owusu-Ansah R, Gatongi D and Chien PF. Health technology assessment of
surgical therapies for benign gynaecological disease. Best Pract Res Clin
Obstet Gynaecol. 2006; 20:841-79.
Pallavi
C,
Dhamangaonkar K,
Anuradha
A
and
Archana
Saxena.
Levonorgestrel intrauterine system (Mirena): An emerging tool for
conservative treatment of abnormal uterine bleeding. J Midlife Health. 2015;
6:26-30.
Papadopoulos NP and Magos A. First-generation endometrial ablation: roller-ball
vs loop vs laser. Best Pract Res Clin Obstet Gynaecol. 2007; 21:915-29.
-110-
Paschopoulos M, Polyzos NP, Lavasidis LG, Vrekoussis T, Dalkalitsis N and
Paraskevaidis E. Safety issues of hysteroscopic surgery. Ann N Y Acad
Sci. 2006; 1092:229-34.
Pellicano M, Guida M, Acunzo G, Cirillo D, Bifulco G and Nappi C.
Hysteroscopic transcervical endometrial resection versus thermal destruction
for menorrhagia: a prospective randomized trial on satisfaction rate. Am J
Obstet Gynecol. 2002; 187:545-50.
Penninx JP, Mol BWJ, Engels R, van Rumste MM, Kleijn C, Coks CA and et
al.
Bipolar
radiofrequency
endometrial
ablation
compared
with
hydrothermablation for dysfunctional uterine bleeding: a randomized
controlled trial. Obstet Gynecol. 2010; 116:819-26.
Penninx JP, Mol BY and Bongers MY. Endometrial ablation with paracervical
block. J Reprod Med; 2009; 54:617-20.
Perez-Medina T and Vallejo MR. Diagnostic and Operative Hysteroscopy. Tirso
Perez-Medina and Enrique Cayuela Font (editors). JAYPEE (Publisher). 2nd
edition. 2011; 13:138-45.
Puchar A, Feyeux C, Luton D and Koskas M. Therapeutic management
of uterine fibroid tumors. Minerva Ginecol. 2015; [Epub ahead of print].
Ray
S
and
Ray
A.
Non-surgical
interventions
for
treating
heavy
menstrual bleeding (menorrhagia) in women with bleeding disorders.
Cochrane Database Syst Rev. 2014; 11:338.
Reid PC, Coker A and Coltart R. Assessment of menstrual blood loss using a
pictorial chart: a validation study. Br J Obstet Gynaecol. 2000; 107:320-2.
-111-
Rishma DP. Thermal Balloon Endometrial Ablation in Dysfunctional Uterine
Bleeding J Gynecol Endosc Surg. 2009; 1:1:31–33.
Roberts T, Tsourapas A, Middleton LJ, Champaneria R, Daniels JP, Cooper
KG and et al. Hysterectomy, endometrial ablation, and levonorgestrel
releasing intrauterine system (Mirena) for treatment of heavy menstrual
bleeding: cost effectiveness analysis. BMJ. 2011; 342.
Rodeghiero F. Management of menorrhagia in women with inherited bleeding
disorders: general principles and use of desmopressin. Haemophilia. 2008;
14:1:21-30.
Romer T. Therapy of recurrent menorrhagia - Cavaterm balloon coagulation
versus roller-ball endometrium coagulation- a prospective randomized
comparative study. Zentralbl Gynakol. 1998; 120:511–14.
Sabbah R and Desaulniers G. Use of the NovaSure Impedance Controlled
Endometrial Ablation System in patients with intracavitary disease: 12month follow-up results of a prospective, single-arm clinical study. J Minim
Invasive Gynecol. 2006; 13:5:467-71.
Sabbah R, Laberge P, Fortin C, Thiel J, Garza-Leal J and Fullop T, et al. A
multi-center, single-arm, international clinical study of the safety and
efficacy of the AURORA endometrial ablation system. Preliminary clinical
results. J Minim Invasive Gynecol 2011; 18:82.
Sambrook AM1, Elders A and Cooper KG. Microwave endometrial ablation
versus thermal balloon endometrial ablation (MEATBall): 5-year follow up
of a randomised controlled trial. BJOG. 2014; 121:6:747-53.
-112-
Sanders S, Purcell S, Silva M, Palerme S and James P. Relationship between
diagnosis
and
intervention
in
women
with inherited bleeding
disorders and menorrhagia. Haemophilia. 2012; 18:273-6.
Shaamash HA and Sayed EA. Prediction of successful menorrhagia treatment
after thermal balloon endometrial ablation. J Obstet Gynaecol Res. 2004;
30:3: 210–16.
Sharma M, Shubham J, Akash S, Oby N, Rakesh K and Meenu B. Role of
saline infusion sonography in abnormal uterine bleeding. Int J Reprod
Contracept Obstet Gynecol. 2013; 2:533-38.
Sharp HT. Endometrial ablation: postoperative complications. AJOG 2012;
207:242-47.
Shawki O, Peters A and Abraham-Hebert S. Hysteroscopic endometrial
destruction, optimum method for preoperative endometrial preparation: a
prospective, randomized, multicenter evaluation. JSLS 2002; 6:23-7.
Silva CD, Geraldes F and Silva IS. Levonorgestrel intrauterine system as a
treatment option for severe menorrhagia in adolescent with type III von
Willebrand disease. BMJ Case Rep. 2013; 1:33-88.
Simon RA, Quddus MR, Lawrence WD and Sung CJ. Pathology of endometrial
ablation failures: a clinicopathologic study of 164 cases. Int J Gynecol
Pathol. 2015; 34:245-52.
Singer A, Almanza R, Gutierrez A, Haber G and Bolduc LR. Preliminary
clinical experience with a thermal balloon endometrial ablation method to
treat menorrhagia. Obstet Gynecol. 2000; 83: 732-34.
-113-
Singh KC, Sengupta R, Agarwal N and Misra K. Thermal endometrial ablation:
a simple technique. Acta Obstet Gynecol Scand. 2000; 79:1:54-9.
Society Of Obstetricians and Gynecologists of Canada (SOGC). Clinical
practice guideline. Abnormal Uterine Bleeding in Pre-Menopausal Women.
JOGC 2013; 35:1-28.
Society Of Obstetricians and Gynecologists of Canada (SOGC). Clinical
practice guideline. Endometrial ablation in the management of abnormal
Uterine Bleeding. JOGC 2015; 37(4):362-376.
Sowter
MC,
Lethaby
A
and
Singla
AA.
WITHDRAWN:
Pre-
operative endometrial thinning agents before endometrial destruction for heavy menstrual bleeding. Cochrane Database Syst Rev. 2014; 7: 11-24.
Soysal ME, Soysal SK and Vicdan K. Thermal balloon ablation in myomainduced menorrhagia under local anesthesia. Gynecol Obstet Invest. 2001;
51:128-33.
Sweet MG, Schmidt-Dalton TA, Weiss PM and Madsen KP. Evaluation and
management of abnormal uterine bleeding in premenopausal women. Am
Fam Physician. 2012; 85:35-43.
Tan YH and Lethaby A. Pre-operative endometrial thinning agents before
endometrial destruction for heavy menstrual bleeding. Cochrane Database
Syst Rev 2013; 11:10-41.
The Menorrhagia Research Group. Quantification of menstrual blood loss.
REVIEW The Obstetrician & Gynaecologist. 2004; 6:88-92.
-114-
Thinkhamrop J, Laopaiboon M and Lumbiganon P. Prophylactic antibiotics for
transcervical intrauterine procedures. Cochrane Database Syst Rev 2007;
3:37-56.
Ulmsten U, Cartensen H and Falconer C. The safety and efficacy of MenoTreat,
a new balloon device for thermal endometrial ablation. Acta Obstet Gynecol
Scand. 2001; 80:1:52-57.
Van Dongen H, de Kroon CD, Jacobi CE, Trimbos JB and Jansen FW.
Diagnostic hysteroscopy in abnormal uterine bleeding: a systematic review
and meta-analysis. BJOG 2007; 114:664-75.
Veena BTand Nirmala SH. Role of Transvaginal Sonography and Diagnostic
Hysteroscopy in Abnormal Uterine Bleeding J Clin Diagn Res. 2014; 8:0608.
Verbalis JG, Goldsmith SR, Greenberg A, Korzelius C, Schrier RW, Sterns
RH and et al. Diagnosis, evaluation, and treatment of hyponatremia: expert
panel recommendations. Am J Med. 2013; 126:1:1-42.
Vitagliano A, Bertin M, Conte L, Borgato S, Leggieri C and Fagherazzi S.
Thermal balloon ablation versus transcervical endometrial resection:
evaluation of postoperative pelvic pain in women treated for dysfunctional
uterine bleeding. Clin Exp Obstet Gynecol. 2014; 41:4:405-8.
Weiss JA. Just heavy menses or something more? Raising awareness of von
Willebrand disease. Am J Nurs. 2012; 112:38-44.
Wilkinson JP and Kadir RA. Management of abnormal uterine bleeding in
adolescents. J Pediatr Adolesc Gynecol 2010; 23(6):22–30.
-115-
Wortman M, Cholkeri A, McCausland AM and McCausland VM. Lateonset endometrial ablation failure--etiology, treatment, and prevention. J
Minim Invasive Gynecol. 2015; 22:323-31.
Wyatt KM, Dimmock PW, Walker TJ and O’Brien PMS. Determination of
total menstrual blood loss. Fertil Steril. 2001; 76:125-31.
Zarek S and Sharp HT. Global endometrial ablation devices. Clin Obstet
Gynecol. 2008; 51:167-75.
Zon-Rabelink I. Rollerball versus Thermachoice. 10th Congress of the European
Society for Gynaecological Endoscopy. Proceedings 2001; 11-14.
-116-