Download Overview of Management and Evaluation of Urinary

SIG Urogynecology –
Overview of Management and Evaluation
of Urinary Incontinence (Didactic)
PROGRAM CHAIR
Neena Agarwala, MD
PROGRAM CO-CHAIR
Vincent R. Lucente, MD
Lawrence L. Lin, MD
Charles R. Rardin, MD
Robert T. O’Shea, MD
Jonathan Y. Song, MD
Sponsored by
AAGL
Advancing Minimally Invasive Gynecology Worldwide
Professional Education Information Target Audience This educational activity is developed to meet the needs of residents, fellows and new minimally invasive specialists in the field of gynecology. Accreditation AAGL is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AAGL designates this live activity for a maximum of 3.75 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. DISCLOSURE OF RELEVANT FINANCIAL RELATIONSHIPS As a provider accredited by the Accreditation Council for Continuing Medical Education, AAGL must ensure balance, independence, and objectivity in all CME activities to promote improvements in health care and not proprietary interests of a commercial interest. The provider controls all decisions related to identification of CME needs, determination of educational objectives, selection and presentation of content, selection of all persons and organizations that will be in a position to control the content, selection of educational methods, and evaluation of the activity. Course chairs, planning committee members, presenters, authors, moderators, panel members, and others in a position to control the content of this activity are required to disclose relevant financial relationships with commercial interests related to the subject matter of this educational activity. Learners are able to assess the potential for commercial bias in information when complete disclosure, resolution of conflicts of interest, and acknowledgment of commercial support are provided prior to the activity. Informed learners are the final safeguards in assuring that a CME activity is independent from commercial support. We believe this mechanism contributes to the transparency and accountability of CME. Table of Contents Course Description ........................................................................................................................................ 1 Disclosure ...................................................................................................................................................... 3 Urinary Incontinence in Women – It Happens to the Best! N. Agarwala ................................................................................................................................................... 4 Evaluation of Urinary Incontinence and Urodynamic Assessment L.L. Lin ......................................................................................................................................................... 13 Non‐Surgical Pharmacologic Treatments of Incontinence – What’s New? J.Y. Song ..................................................................................................................................................... 23 Evolution of Surgical Management of Incontinence R.T. O’Shea .................................................................................................................................................. 29 Does She Have Prolapse? Obliterative or Reconstructive Surgery and Incontinence V.R. Lucente ................................................................................................................................... 36 Occult Stress incontinence – Treat or Not? N. Agarwala ................................................................................................................................................. 51 Fistulae, Diverticulae and Sphincter Urethrae C.R. Rardin ................................................................................................................................................... 55 Refractory OAB – Interstim and Botox Treatment of Urinary Incontinence L.L. Lin ......................................................................................................................................................... 59 Cultural and Linguistics Competency ......................................................................................................... 66 PG 211
SIG Urogynecology – Overview of Management and Evaluation
of Urinary Incontinence (Didactic)
Neena Agarwala, Chair
Vincent R. Lucente, Co-Chair
Faculty: Lawrence L. Lin, Robert T. O’Shea, Charles R. Rardin, Jonathan Y. Song
This course with include an overview of the evaluation of various types of urinary incontinence with
history, exam and office evaluation focus. We shall discuss the diagnostic criteria for stress incontinence,
overactive bladder, urge incontinence, mixed incontinence, overflow incontinence and functional
incontinence. We shall discuss patient symptoms, voiding diary, office exam and evaluation including
simple and complex cystometric evaluation for more complex situations. Management options shall
include medication therapy, behavior modification, office treatments, non-surgical options and surgical
treatment choices. We shall also discuss the sling procedure, its pros, cons and expectations, tips and
tricks and the various modifications, indications and types of slings. Other surgical options will be
discussed, including the Interstim treatment, along with its benefits and risks, and Botox treatment. We
will cover cystoscopy and its indications as well.
Finally, we will discuss a few cases highlighting some uncommon and complex clinical situations like
urethral diverticulae, prolapse masking incontinence and neurogenic bladder conditions.
Learning Objectives: At the conclusion of this activity, the clinician will be able to: 1) Review the
different types of incontinence; 2) discuss the office evaluation along with cystometrics; 3) discuss nonsurgical treatment options with a patient; 4) discuss surgical options, indications and outcomes; 5)
evaluate a patient with complex presentation; and 6) use the learning process to understand the
complex interaction between prolapse and incontinence.
Course Outline
1:30
Welcome, Introductions and Course Overview
N. Agarwala
1:35
Urinary Incontinence in Women – It Happens to the Best!
N. Agarwala
2:00
Evaluation of Urinary Incontinence and Urodynamic Assessment
2:25
Non-Surgical Pharmacologic Treatments of Incontinence – What’s New?
2:50
Evolution of Surgical Management of Incontinence
3:15
Questions & Answers
3:25
Break
3:40
Does She Have Prolapse? Obliterative or Reconstructive Surgery and Incontinence V.R. Lucente
L.L. Lin
J.Y. Song
R.T. O’Shea
All Faculty
1
4:05
Occult Stress Incontinence – Treat or Not?
N. Agarwala
4:30
Fistulae, Diverticulae and Sphincter Urethrae
4:55
Refractory OAB – Interstim and Botox Treatment of Urinary Incontinence
5:20
Questions & Answers
5:30
Course Evaluation/Adjourn
C.R. Rardin
L.L. Lin
All Faculty
2
PLANNER DISCLOSURE
The following members of AAGL have been involved in the educational planning of this workshop and
have no conflict of interest to disclose (in alphabetical order by last name).
Art Arellano, Professional Education Manager, AAGL*
Viviane F. Connor
Consultant: Conceptus Incorporated
Kimberly A. Kho*
Frank D. Loffer, Executive Vice President/Medical Director, AAGL*
Linda Michels, Executive Director, AAGL*
M. Jonathan Solnik*
Johnny Yi*
SCIENTIFIC PROGRAM COMMITTEE
Ceana H. Nezhat
Consultant: Ethicon Endo-Surgery, Lumenis, Karl Storz
Other: Medical Advisor: Plasma Surgical
Other: Scientific Advisory Board: SurgiQuest
Arnold P. Advincula
Consultant: Blue Endo, CooperSurgical, Covidien, Intuitive Surgical, SurgiQuest
Other: Royalties: CooperSurgical
Linda D. Bradley*
Victor Gomel*
Keith B. Isaacson*
Grace M. Janik
Grants/Research Support: Hologic
Consultant: Karl Storz
C.Y. Liu*
Javier F. Magrina*
Andrew I. Sokol*
FACULTY DISCLOSURE
The following have agreed to provide verbal disclosure of their relationships prior to their
presentations. They have also agreed to support their presentations and clinical recommendations
with the “best available evidence” from medical literature (in alphabetical order by last name).
Neena Agarwala*
Lawrence Lin*
Vincent R. Lucente
Grants/Research: American Medical Systems, Bard Medical Division, Kimberly-Clark
Consultant: Allergan, American Medical Systems, Bard Medical Division, Kimberly-Clark
Speakers Bureau: Allergan, American Medical Systems, Bard Medical Division
Robert T. O’Shea*
Charles R. Rardin*
Jonathan Y. Song*
Asterisk (*) denotes no financial relationships to disclose.
Disclosure
I have no financial relationships to disclose.
Incontinence: Can happen to the best!
Neena Agarwala, MD, MSc
Associate Clinical Professor
St. Luke’s Roosevelt Hospital Medical Center
Columbia University Affiliate
New York, NY
Epidemiology
Urogenital Damage/dysfunction:
Neurologic
Trauma
Hormonal changes
Anatomical weakness of the support structures
• Pharmacologic
•
•
•
•




Vaginal delivery ‐Pregnancy and childbirth
Aging Estrogen deficiency‐ Hormone effects
Neurological disease
 Non obstetric pelvic trauma and radical surgery
 Increased intra‐abdominal pressure
 Drug effects
Causes of Incontinence:
Aging:




Inherited or genetic factors
 Race
 Anatomic differences
 Connective tissue
 Neurologic abnormalities
4
Gravity
Neurologic changes with aging
Loss of estrogen
Changes in connective tissue crosslinking and reduced elasticity
Compounding Problems:
Barriers to Treatment




Embarrassment leads to silence
Time constraints lead to inadequate attention
Knowledge limits lead to patient acceptance
Technology limits lead to inadequate investigation
 Resource limits lead to inadequate access
• Patient misconceptions and fears:
“Part of normal aging or everyday life”
“Not severe or frequent enough to treat”
“Too embarrassing to discuss”
“Treatment won't help”
 Nothing can be done about it
 Surgery is the only solution
Symptoms:
Barriers to Treatment









• Healthcare providers
– ONLY 30% of patients who seek treatment receive treatment
Prevalence of Urinary Incontinence
Age (yr.)
Female*
Male*
<30
16 - 52%
6 - 10%
30 - 60
17 - 39%
2 - 12%
>60
4.5 - 44%
4.6 - 24%
22 - 90%
22 - 33%
Prevalence of incontinence
•
•
•
•
•
•
Institutionalized/
Impaired
Frequency
Nocturia
Dysuria
Incomplete emptying
Incontinence
Urgency
Recurrent infections
Dyspareunia
Prolapse
•
•
•
*broad prevalence ranges due to variability of UI definition
 Estimated at 10 - 35% of adults
•
 50% of institutionalized patients
•
•
Fantl et al. Managing Acute and Chronic Urinary Incontinence. Rockville, MD: Agency for Health Care Policy and Research; 1996. AHCPR
Publication No. 96-0686.
National Center for Health Statistics. Vital Health Statistics Series 13 (No. 102), 1989.
5
8‐51% in community
10‐25% of women 15‐64 years old
At least 50% in nursing homes. 25% suffer from severe incontinence
Greatest in older women and increases with age
Incontinence 6‐10x greater in women than in men
By 2040 22% of female population will be>65
As the proportion of PMP women increases over the next 30 years, these conditions will become even more prevalent. A woman's lifetime risk of surgery for prolapse or urinary incontinence is 11.1% by the age of 80.
Affects at least 13 million Americans of all ages
85% are women
Recent Gallup survey indicates that ~70% of these women have symptoms of stress incontinence
Statistics:
Statistics:
 10‐25% of women age 15‐64 report urinary incontinence
 15‐40% of women over age 60 in the community report incontinence
 More than 50% of women in nursing homes are incontinent
 W.H.O. recognizes incontinence as an international health concern
 10‐60% of women report urinary incontinence
 50% of women that have had children develop prolapse
 Only 10‐20% seek medical care
 Billions of dollars spent annually on incontinence products (in North America)
Estimated Economic Costs of Overactive
Bladder in the US in Year 2000
Cost of Urinary Incontinence
1994 - Direct Costs1
Community
Institutional
$13.8 billion
$4.4 billion
- $11.2 billion/year in the community
- $5.2 billion/year in nursing homes
 60% greater than the 1990 estimate2
 Does not count urgency/frequency alone
1995 - Total Societal Costs3
- individuals +65 - $26.3 billion/year
- per person cost - $3,565 /year
( 174% from 1884)
Total economic costs
$18.2 billion
1. Hu. National Multi-Specialty Nursing Conference on Urinary Incontinence, 1994.
2. Hu. J Am Geriatr Soc. 1990;38:292-295.
3. Wagner. Urology. 1998;51(3):355-361
Hu T et al. WHO/ICI 2001. Abstract.
Costs of Urinary Incontinence
Frequency of Selected Chronic
Conditions in the United States
Total Cost in 1995 > $26 Billion U.S.
Overactive Bladder?
$3,600 annually per person aged  65 years
Incontinence
consequence
costs
50%
Routine
costs
43%
Indirect
costs
3%
Diagnostic
costs
1%
Treatment
costs
3%
Millions
†
Source: Wagner TH, Hu TW. Urology. 1998;51:355-361.
6
Stewart, W., et al. World J Urol. In press.
Pleis, JR and R Coles. Summary Health Statistics for U.S. Adults: National Health Interview Survey,
1998. National Center for Health Statistics. Vital Health Stat. 2002:10(209).
Impact of Overactive Bladder on Quality of
Life Compared to Other Conditions
90
Quality of Life Impact:






80
Normal
Impact on lifestyle and avoidance of activities
Fear of losing bladder control
Embarrassment
Impact on relationships
Increased dependence on caregivers
Discomfort and skin irritation
70
Hypertension
Diabetes
60
Overactive bladder
Depression
50
40
0
Emotional
Physical
Vitality
Bodily
Limitations
Pain
Functioning
Physical
Mental
General
Social
Limitations
Health
Health
Function
Kobelt-Nguyen et al. 27th annual meeting of ICS, 1997.
Medical Sequelae of
Incontinence






New and revised terms are relatively vague to allow for patient‐to‐patient variability
Increased risk of slips and falls
Prevalence: 20-40% with 90% causing fx, in
women over 65
• Overactive bladder is a syndrome of symptoms that suggest dysfunction of the lower urinary tract. It is characterized by urgency with or without urge incontinence, usually involving frequency and nocturia. • Urinary incontinence is any involuntary leakage of urine. • Daytime frequency. The patient feels she voids more frequently than she should during the day. • Nocturia. The patient wakes 1 or more times at night to void. • Urgency. The patient feels a sudden, compelling desire to pass urine. Incontinence, significant risk factor for hip
fracture
Infection, local or systemic
Skin irritation or breakdown
Dehydration
Innervation of the LUT
Types of Urinary Incontinence:
Inferior mesenteric ganglion
Sympathetic: relaxes




Trigone
Genuine stress incontinence
Urge incontinence
Mixed
Chronic urinary retention and overflow incontinence
 Functional incontinence
 Miscellaneous (UTI, dementia)
 Total incontinence
Urethra
Parasympathetic: contracts
T10-L2
Somatic
S2-S4
Adapted from Abrams P, Wein AJ. The Overactive Bladder:
A Widespread and Treatable Condition. Erik Sparre Medical AB; 1998.
7
External
urethral
sphincter
Muscles of the
pelvic floor
Neurologic control in voiding
Types of Urinary Incontinence • Normal mechanism is a cortical control of voiding reflexes mediated by pontine micturation center and sacral cord
• It suppresses bladder contractions until conscious desire to void
• Upper motor neuron lesion –
overactivity
• Lower motor neuron lesion –
underactivity
Heart = Tachycardia
Gall Bladder
Stomach = Dyspepsia
Colon = Constipation
Bladder (detrusor muscle)
Adapted from Abrams P, Wein AJ. The Overactive Bladder:
A Widespread and Treatable Condition. Erik Sparre Medical AB; 1998.
Muscarinic Receptors
Brain
Glands
Heart
M2
M3
M4
M5
X
X
X
X
X
X
X
X
GI
Bladder
 Loss of urine with increases in abdominal pressure
 Caused by pelvic floor damage/weakness or weak sphincter(s)
 Symptoms include loss of urine with cough, laugh, sneeze, running, lifting, walking
X
X
X
X
Sudden increase
in intra-abdominal
pressure
Uninhibited
detrusor
contractions
Urethral pressure
Genuine Stress Incontinence:
M1
Eyes
Stress
 urine loss resulting from sudden
increased intra-abdominal
pressure (eg, laugh,
cough,sneeze)
– combination of stress and urge incontinence
• Urge incontinence is caused by overactivity of the bladder muscle.
• This overactivity may be caused by an irritation of the bladder, emotional stress, or medical conditions such as Parkinson's disease or a stroke.
• Micturation reflex ‐>
Salivary Glands = Dry Mouth
Muscarinic receptors are
also located in the CNS.

• Mixed symptoms
Factors causing incontinence
Iris/Ciliary Body = Blurred Vision
Lacrimal Gland = Dry Eyes
• Dizziness
• Somnolence
• Impaired Memory & Cognition
Urge
 urine loss
accompanied by
urgency resulting
from abnormal
bladder
contractions
Distribution of Muscarinic Receptors Parasympathetic Nervous System
CNS

X
8
Urge Incontinence:
Overactive Bladder
 Loss of urine due to an involuntary bladder spasm (contraction)
 Complaints of urgency, frequency, inability to reach the toilet in time, up a lot at night to use the toilet
 Multiple triggers
• Overall prevalence of OAB is estimated at 16.6%
• Prevalence of OAB is almost equal in women and men (16.9% vs 16.2%, respectively) and increases with age
• OAB affects approximately 33.3 million adults in the US, nearly 24 million of whom are older than 45 years
• OAB significantly impairs HRQoL, even in those without urge incontinence
NOBLE: Prevalence of OAB in the US
Characteristic Symptoms of OAB 16.6% of the adult population
(age 18 years)
OAB
Bladder pressure greater
than urethral pressure
• Can be dry or wet
• Frequency
and
• Urgency
• Urge incontinence
33.3 million adults
US population = 200 million adults*
*Estimate based on 2000 US census
Adapted from Stewart W et al. WHO/ICI 2001. Poster.
OAB Symptoms
Symptoms
Frequency
• Symptoms of urge incontinence include the need to urinate frequently and a sudden, urgent need to urinate.
• 8 or more visits to the toilet per 24 hours
Urination at night
• 2 or more visits to toilet
during sleeping hours
Urgency
Urge Incontinence
• Sudden, strong
desire to urinate
• Sudden & involuntary
loss of urine
OAB
9
Addressing Transient Conditions That Mimic OAB
Economic & Social Costs
• Easily reversible conditions • Number one indication for admission to an assisted or extended care living
• This is an underserved patient population
• Extended care facilities welcome the help
– urinary tract infection
• Associated conditions – urogenital aging
– bladder outlet obstruction
– prolapse
– stress incontinence
– voiding difficulties
Mixed Incontinence:
Chronic Urinary Retention:
 Outlet obstruction or bladder underactivity
 May be related to previous surgery, aging, development of bad bladder habits, or neurologic disorders
 Medication, such as antidepressants
 May present with symptoms of stress or urge incontinence, continuous leakage, or urinary tract infection
 Combination of stress and urge incontinence
 Common presentation of mixed symptoms
 Urodynamics necessary to confirm
Functional and Transient Incontinence:






Unusual Causes of Urinary Incontinence:
Mostly in the elderly
Urinary tract infection
Restricted mobility
Severe constipation
Medication ‐ diuretics, antipsychotics
Psychological/cognitive deficiency
 Urethral diverticulum
 Genitourinary fistula
 Congenital abnormalities (bladder extrophy, ectopic ureter)
 Detrusor hyperreflexia with impaired contractility
10
Potential Etiologic Factors for SUI
Factors causing incontinence
• Stress incontinence is caused by descent of bladder and or urethra
• Anatomic factors following childbirth
• Thinning of the pelvic floor musculature
• Decreased collagen synthesis in urethra
• Previous pelvic surgery
• Smoking, chronic constipation
• Aging, estrogen deficiency
–
–
• Elasticity, vascularity and thickness of urethra depends on estrogen status
– Menopause
• Urethral function needs adequate reflex muscular contractions in stress, but pelvic floor denervation may destroy it
– Age
– Childbirth
Hormone Effects:
Pregnancy and Childbirth:
 Common embryonic origin of bladder urethra and vagina from urogenital sinus
 High concentration of estrogen receptors in tissues of pelvic support
 General collagen deficiency state in postmenopausal women due to the lack of estrogen (Falconer et al., 1994)
 Urethral coaptation affected by loss of estrogen
 Hormonal effects in pregnancy
 Pressure of uterus and contents
 Denervation (stretch or crush injury to pudendal nerve)
 Connective tissue changes or injury (fascia)
 Mechanical disruption of muscles and sphincters
Resources
Resources
• Chapple
• Churchill, Livingston 2000
• Ostergard
• Lippincott 2003
–
–
–
–
–
Age
Childbirth
– “This book aims to dispel the image that urodynamics is a complex subject.”
New
Well written
Comprehensive Terminology changes
Internet section
11
Resources
Resources
Walters, Karram
Mosby, 1998
•
•
•
•
•
Payne CK. Campbell’s Urology Updates. 1999;1:1-20.
Evans DA et al. Milbank Q. 1990;68:267-289.
Bureau of the Census, Population Estimate Data, 1995.
National Institutes of Health. Osteoporosis and Related Bone Diseases
National Resource Center. Osteoporosis Overview.
National Center for Health Statistics. Vital Health Stat. 10(199):1998.
12
www.augs.org
(urogyn society)
www.continet.org (ICS)
www.ichelp.org
(interstitial cystitis)
www.suna.org
(nurses, CNP)
www.reiters.com (Reiter’s Books)
Disclosure
I have no financial relationships to disclose.
Evaluation of Urinary Incontinence and Urodynamic Assessment
Lawrence Lin MD
Thousand Oaks, CA
History and Physical Exam
The main objectives: • Develop a better understanding of multi‐channel urodynamic studies
• Focus on clinical “Case Scenarios” of abnormal urodynamic studies. 3 most common types incontinence & voiding dysfunction.
(1) Stress incontinence
(2) Overactive bladder  Mixed incontinence
(3) Incomplete bladder emptying.
History and Physical Exam
History and Physical Exam
For stress incontinence:
• Leak with cough, laugh, sneeze
• Leak with exercise
• Leak with walking, bending over, lifting things
• How often do you leak? (Severity of leakage)
For overactive bladder
• Worsening urgency
• Worsening frequency
• Nocturia (x > 2 abnormal)
• Urge incontinence. • Leak before you reach the toilet
‐ Once per day ‐ Couple of times per week ‐ Couple of times per month ‐ Once every few month
• Do you wear a pad? Thin or thick pad?
13
History and Physical Exam
History and Physical Exam
Differential Diagnosis:
For incomplete bladder emptying
• How many times ‐void daytime (x > 8 abnl)
• How many times‐ void at night (x > 2 abnl) • Often needs to void for 2nd or 3rd time after initial void
• Hard to begin urinating
• Slow urinary stream
• Strain to void. Needs to lean forward to void. Needs to push on bladder to void.
Need to rule out other medical and neurological conditions such as:
• Diabetes
• Stroke
• Back injury or Lumbar disc disease
• COPD / Chronic cough
• Chronic constipation  voiding dysfunction
• Previous prolapse surgery or vaginal surgery
• Previous incontinence surgery
• Radiation to pelvis
• Medication  voiding dysfunction
History and Physical Exam
History and Physical Exam
Physical Exam:
• Hypermobile urethra with Q‐tip change x > 30 degrees
• R/O vaginal atrophy vs OAB • R/O vaginal discharge
• R/O prolapse ‐‐ > incomplete bladder emptying
Neurologic Exam: • Evaluate mental status dementia etc
• Evaluate sensory function of the lower extremities
• Evaluate motor function of the lower extremities
e.g. Parkinksons, Multiple sclerosis, Cerebrovascular Disease etc.
Work Up
•
•
•
•
Work Up
24 hr bladder diary
R/O UTI. Check UA and culture
R/O emptying: Void and post void residual
Pad tests
Normal Values:
• Normal bladder capacity is 400‐500 cc.
• Normal voiding: a. Should empty 80‐90% of total bladder capacity b. Or PVR x < 100 cc. ‐Simple pad test: Count the number of pads changed per day
‐1 hour pad test: Weigh the pad after 1 hr (after drinking 500 ml)
‐24 hr pad test
14
Office Diagnostic Tests
Office Diagnostic Tests
Two office tests
(1) Simple CMG (Cystometrogram)
(2) Multi‐channel urodynamic testing
Simple CMG (Cystometrogram)
single channel
catheter
From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby.
Office Diagnostic Tests
Multichannel urodynamic studies (UDS)
Simple CMG (Cystometrogram)—single channel
(1) First, check void volume and PVR.
(2) Bladder is filled with sterile water using a 50 cc Toomey syringe
(3) Measure 1st sensation and maximum bladder capacity
(4) (+) DI if there is a change in the water level
(5) Cough test at 200, 300, and 400 cc. 1. Is UDS indicated for straight forward SUI?
Ans: Not indicated by the AUA guidelines.
2. What are the indications for UDS?
Ans: (a) SUI without urethral hypermobility
(b) Mixed incontinence
(c) Failed incontinence surgery
(d) Failed OAB / urge incontinence surgery
Multichannel Urodynamic Studies.
UROFLOW
Office Diagnostic Tests
Uroflow:
amount urine voided over time X‐axis: Time (in seconds)
Y‐axis: Flow rate (ml/sec)
Multichannel Urodynamic Studies—4 main parts
1) Uroflow
2) Complex CMG (Cystometrogram)
3) Urethral Pressure Profile (UPP)
4) Pressure Flow Study (PFS)
Normal Uroflow curve should look like a normal bell shaped curve
Normal values: • NL flow: if pt voids at least 200 ml over 15‐20 sec
• Normal: “Max flow rate:” x > 20 ml/sec. Average Flow rate 10 ml/s
• Abnormal: “Max flow rate:” x < 15 ml/sec
Average Flow rate x < 5 ml/sec
From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby.
15
Multichannel Urodynamic Studies:
UROFLOW
Multichannel Urodynamic Studies:
UROFLOW
What is the role of uroflow?
Maximum Flow Rate
Ans: To evaluate voiding dysfunction or bladder emptying problems. Median flow rate
From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby.
Multichannel Urodynamic Studies:
UROFLOW
Multichannel Urodynamic Studies:
UROFLOW
I. Normal uroflow pattern: Bell shaped curve
Advantage of the uroflow is that it is a noninvasive test to document voiding function and dysfunction. It is considered a good screening test. II. Abnormal uroflow pattern.
a. Superflow pattern—suggestive of ISD
(poor urethral resistance)
b. Obstructive voiding patterns
i. Abnormal detrusor contractility (e.g. Incomplete bladder emptying / Neurogenic bladder)
ii. Urethral obstruction / resistence
iii. Both above (e.g DSD—detrusor sphincter dyssynergia)
Disadvantage: It does not provide direct information about detrusor pressures or outlet resistence. Case scenario # 1
ISD. Intrinsic sphincter deficiency.
Multichannel Urodynamic Studies:
UROFLOW
Case scenario # 1
Intrinsic sphincter deficiency (ISD)
Normal void takes 15‐20 second to void 200 ml. In this case, the patient voids 400 cc in 5‐
10 seconds. Time (seconds)
From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby.
From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery Missouri 1999 Mosby
16
Incomplete bladder emptying:
(1) Voided 150 cc. PVR 900 cc. (2) Maximum flow rate 18 ml/sec. Flow time 16 seconds. (3) Now starting to develop recurrent UTIs. Case scenario # 2
Incomplete bladder emptying
NORMAL VALUES: PVR < 100 cc or Empty 80‐90% of total bladder volume. 53 y/o with a history of incomplete bladder emptying x 10 years that is getting progressively worse. During the daytime, she voids every 1 hr. Nocturia 4‐5 x per night. Normal
Flow Rate Incomplete (ml/s) emptying
Volume (cc)
Normal
Incomplete emptying
Multichannel Urodynamic Studies:
UROFLOW
Incomplete bladder emptying
Another example: Void 450. PVR 200
Case Scenario # 3:
(2) Outlet obstruction. (Ex. TVT sling too tight)
Sinusoidal pattern. Flow rate based on Valsalva alone. The moment you stop Valsalva, you have no flow. The wave like pattern represents contraction of the abdominal muscle or contraction of the external urethral sphincter. Flow rate
(ml/s)
Vol
voided
(ml)
C
Multichannel Urodynamic Studies:
UROFLOW
Case Scenario # 2:
Case Scenario # 3: (2) Outlet obstruction. (Ex. TVT sling too tight)
Outlet Obstruction (ex. Sling too tight)
Case Scenario # 4:
(3) Outlet obstruction. (Ex. Enlarged prostate)
Prolonged bell shaped curve. Prolonged voiding times. Instead of voiding in 15‐20 seconds, pt voids over a time period of 1‐5 minutes. From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby.
17
Multichannel Urodynamic Studies:
UROFLOW
C Case Scenario # 2:
Case Scenario # 4: (2) Outlet obstruction. (Ex. TVT sling too tight)
Outlet Obstruction (Ex. Enlarged prostate)
Abnormal slow flow rate over prolonged time
Case Scenario # 5
(4) MVA. Neurologic lesion, classically high spinal cord trauma. Detrusor sphincter dyssynergia (DSD). This is a condition where there is a lack of coordination between the detrusor muscle and the external striated urethral sphincter muscle.
Flow Rate
(ml/sec)
cology and 1999, Mosby.
Time (sec)
From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby.
Multichannel Urodynamic Studies:
Complex CMG (Cystometrogram)
C Case Scenario # 2:
Case Scenario # 5: (2) Outlet obstruction. (Ex. TVT sling too tight)
Detrusor Sphincter Dyssynergia
(Intermittent multi‐peaked pattern)
Flow Rate
(ml/sec)
Time (sec)
From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby.
From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby.
Complex CMG
P ves: Pressure in bladder
P abd: Pressure in vagina
Pdet: Pves – P abd
4 Case Scenarios
DETRURSOR PRESSURE:
A: Normal bladder pressure. During normal bladder filling, the bladder pressure is low
(P det < 40 cm H20)
P ves
P abd
P det
B. Overactive bladder. Increased detrusor overactivity. Bladder contractions with a return to baseline.
C: Phasic contractions with a gradual rise in true detrusor
pressure
Fill Volume
(ml)
D: Low compliance bladder. Steady rise in detrusor
pressure
From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby.
18
Multichannel Urodynamic Studies:
Complex CMG
Multichannel Urodynamic Studies:
Complex CMG
Results from Complex CMG
1. SUI and the severity of the SUI.
2. Intrinsic Sphincter Deficiency (ISD)
3. Overactive bladder
4. Mixed incontinence
5. Small bladder capacity
6. Detrusor areflexia (aka bladder acontractility)
7. Poor Bladder Compliance. Advantage of the Complex CMG is that it provides information on detrusor pressure and the abdominal pressure. Disadvantage of Complex CMG is that this is an invasive test, and 20‐30% of patients are not able to void around the catheter. Case Scenario # 1: Stress urinary incontinence (SUI)
Multichannel Urodynamic Studies:
Complex CMG
Case Scenario # 1: Stress urinary incontinence (SUI)
Patient leaks with coughing, laughing, sneezing,
and any type of physical activity. Failed Kegel
exercises.
P ves
P abd
P det
Intrinsic Sphincter Deficiency
Clincally, UDS shows that she leaks copious amounts, like a faucet. VLPP = 20 cm H20
Multichannel Urodynamic Studies:
Complex CMG
Case Scenario # 2:
Instrinsic Sphincter Deficiency (ISD)
52 y/o female that complains that she leaks multiple times a day. Wears a heavy duty pad and she changes this pad multiple times per day. Leaks even with walking or bending over. Cough stresstest in the office shows copious amounts. Valsalva leak point pressure (VLPP < 60 cm H20)
P ves
P abd
P det
Fill Vol
(ml)
19
Multichannel Urodynamic Studies:
Complex CMG
(+) Detrusor overactivity:
At 160 cc, she leaks ½ of her total bladder volume
At 320 cc, leaks another ½ of her total bladder volume Case Scenario # 3:
Overactive bladder (aka Detrusor overactivity)
Pt is a 79 y/o female with complete procidentia
and worsening bladder urgency and frequency. complains of bladder urgency, frequency, and nocturia. Also (+) urge incontinence. Leaks when she hears running water and leaks just watching TV.
P ves
P abd
P det
Complex CMG Case Scenario # 4: Mixed incontinence.
Case Scenario # 5: Small bladder capacity (Sensory urgency): Pt voids every 1 hour during the daytime. Nocturia 3‐4 x per night. Never gets a good nights sleep. Uroflow shows a total void volume of 100 cc and she states that was very full. Bladder study shows no DO. From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby.
P abd
P ves
P det
From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby.
Multichannel Urodynamic Studies:
Urethral Pressure Profile (UPP)
Complex CMG Case Scenario # 6. Neurogenic
bladder (Hyposensitive bladder). Pressure‐Flow Studies (Complex CMG)
Case Scenario # 6.: Small bladder capacity (Sensory urgency): Pt voids every 1 hour Pt complains that she has overflow incontinence. She has no during the daytime. Nocturia
3‐4 x per night. Never gets a good nights sleep. Uroflow
sensation that her bladder is full. She has no urge to void. She shows a total void volume of 100 cc and she states that was very full. Bladder study needs to void on a set schedule every 2‐3 hours otherwise she has shows no DO. . • Normal female urethra is approx 4 cm in length
• UPP test—main function is to diagnosis Instrinsic Sphinter Deficiency (ISD)
• Normal urethral closure pressure (Uclo x > 20 cm H20)
• Abnormal urethral closure pressure (Uclo x < 20 cm H20) leakage. History of recurrent UTIs. History of Multiple Sclerosis.
From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby.
20
Multichannel Urodynamic Studies:
Urethral Pressure Profile (UPP)
A: Both transducers start inside the bladder.
B: As the catheter is mechanically withdrawn through the urethra, the urethral and bladder pressures are recorded. From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby.
From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby.
Multichannel Urodynamic Studies:
Urethral Pressure Profile (UPP)
Column A: Continent patient. Urethral pressures >> Bladder pressures. No pt has no leakage.
Intrinsic Sphincter Deficiency (ISD)
a. Uclo pressure < 20 cm H20
b. Valsalva Leak Point Pressure x < 60 cm H20
c. Clinically, she leaks with walking or any type of simple activity.
d. UDS: Leaks copious amounts, like a faucet with cough or Valsalva. Column A
Column B
Column B: Incontinent patient. Uclo < 20 cm H2O. Urethral pressures << Bladder pressure. (+) urinary incontinence
From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby.
Pressure‐Flow Study Pressure‐Flow Study Normal pressure flow study : Pt voids with urethral relaxation and bladder contraction. Two phases:
(1) Filling phase: Phase I: slight rise in bladder pressure. Phase II: Bladder accommodation. Phase III: (2) Voiding phase: At maximum bladder capacity. Phase IV: (+) detrusor contraction and then pt voids. Indications for Pressure Flow Study?
Ans: To distinguish between obstructed flow versus hypocontractile / acontractile flow.
Examples:
• Urinary retention 1 month after bladder botox
• Sling too tight with slow stream
• DSD (Detrusor sphincter dyssynergia)
From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby.
21
Pressure‐Flow Study
Case: Normal filling and voiding. No SUI. No overactive bladder. At max capacity, detrusor contraction leads to drop in urethral closure pressure, and voiding initiated. Pressure Flow Study
Case Scenario :
Post‐op obstruction from recent TVT sling
Pre‐op UDS shows pt voided normally with low post void residual. After her sling procedure, she now complains that she needs to empty for a second or a third time after her initial void. PFS show high detrusor pressure with a low flow rate. P abd
P ves
P det
From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby.
Post‐op obstruction from recent TVT sling
High bladder pressure. High detrusor pressure. Low flow rate. High post void residual. Pressure‐Flow Study Acontractile bladder: Pt voids by Valsalva
maneuver only. Absent bladder contractions. P ves
P abd
Clinically, pt needs to bend over or push suprapubically on her bladder in order to better empty her bladder. P det
Flow rate (ml/s)
Vol voided
(ml)
Normal flow rate
Abnormal flow rate
From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby.
Case scenario
Previous TOT sling 1 week ago with voiding dysfunction and difficulty emptying bladder.
(1) Do you need to repeat another UDS?
(2) How long do you wait before you decide to take the patient back to the OR to loosen the sling?
(3) Do you loosen the sling or do you cut the sling? (4) How do you loose the sling?
Thank you
22
Non-Surgical Pharmacologic
Treatments of Incontinence –
What’s New?
Disclosures
Jonathan Y. Song, MD, FACOG, FACS
TLC Medical Group, S.C.
I have no financial relationships to disclose.
Medical Director
Robotics and Minimally Invasive Surgery
Presence Mercy Medical Center
Medical Director
Robotics and Minimally Invasive Surgery
Cadence Health - Delnor Hospital
Assistant Professor
Department of Obstetrics and Gynecology
Rush University Medical Center
Objectives
Urinary Incontinence
After completing this course the
participant will be able to:





Differentiate the types of pessaries available to treat
incontinence
Distinguish pharmacologic agents used to treat
incontinence by drug class
Choose the appropriate first-line medication to use
for uncomplicated urge incontinence

1. Swift SE. Epidemiology of Pelvic Organ Prolapse and Urinary Incontinence. Ostergard’s Urogynecology; 2008: 27-38
Urinary Incontinence
Stress Incontinence (50%)




Involuntary leakage of urine with
effort or exertion or valsalva
Leakage of urine with abdominal
contraction in absence of detrusor
contraction
Urethral dysfunction;
urethrovesical hypermobility
Can be caused by Intrinsic
Sphincter Deficiency
Estimated between 23% to 35% of adult women
Prevalence increases with age until 50 where it
plateaus
Difficult to obtain specific percentages of different
types of incontinence
Pessaries
Urge Incontinence (25%)



Interchangeably termed with
Overactive Bladder
Sudden compelling desire to
urinate that is difficult to defer
Idiopathic/Myogenic/Neurogenic



Mixed Incontinence (25%)


May manifest as both emptying
and storage abnormalities
Involves neuropathic conditions
due to:
trauma/inflammation/Infection/De
generation
2. Abrams P, Cardozo L, Fall M, et al Urology 2003;61:37-49
3. Cucchi A, Siracusano S, Guarnaschelli C, et al Neurourol Urodyn 2003;22:223-226.
23
Made of medical-grade
silicone
Very durable
Low likelihood of foulsmelling vaginal
discharge
Pessaries for Incontinence
Pessaries for Incontinence
Ring with Support




Gellhorn

Resembles a large
diaphragm
Effective and comfortable
for patients
Works well for almost all
types of defects
Easier for patients to insert
and withdraw




4. Culligan PJ. Nonsurgical management of pelvic organ prolapse. Obstet Gynecol 2012;119:852-860.
6. Schaffer J, Rahn DD, Wieslander CK. Overview of Treatment. Ostergard’s Urogynecology; 2008: 454-462.
4. Culligan PJ. Nonsurgical management of pelvic organ prolapse. Obstet Gynecol 2012;119:852-860.
6. Schaffer J, Rahn DD, Wieslander CK. Overview of Treatment. Ostergard’s Urogynecology; 2008: 454-462.
Pessaries for Incontinence
Pessaries for Incontinence
Doughnut




Resembles a mushroom
Effective and comfortable
Should be used as secondline pessary when initial one
fails
Creates more friction and
suction
May be more difficult for
patients to insert/remove
Gehrung (w/wo Knob)

Space-filling
Can be useful and effective
Difficult to insert and
remove
Produces most amount of
vaginal discharge and odor




4. Culligan PJ. Nonsurgical management of pelvic organ prolapse. Obstet Gynecol 2012;119:852-860.
6. Schaffer J, Rahn DD, Wieslander CK. Overview of Treatment. Ostergard’s Urogynecology; 2008: 454-462.
Manually molded to fit
almost any type and size of
prolapse present
9 different sizes in all
Can correct vaginal vault
prolapse
Can be technically
challenging for some paients
Not commonly used
4. Culligan PJ. Nonsurgical management of pelvic organ prolapse. Obstet Gynecol 2012;119:852-860.
6. Schaffer J, Rahn DD, Wieslander CK. Overview of Treatment. Ostergard’s Urogynecology; 2008: 454-462.
Nervous System
Pessaries for Incontinence
Central Nervous System
(CNS)
Bladder Neck Supporter5
(Introl)




Provides enhanced angle to
the bladder neck
Supports urethrovesical
junction
Difficult to insert and
remove for the patient

Brain
Spinal Cord
Peripheral Nervous System
(PNS)


Afferent Division
Efferent Division


Somatic System (voluntary)
Autonomic System (involuntary)

Sympathetic



Parasympathetic

5. Pott-Grinstein E, Newcomber JR. Gynecologists’ pattern of prescribing pessaries. J Reprod Med 2001;46:205-208.

24
Alpha and Beta Receptors
Epinephrine/Norepinephrine
Muscarinic/Cholinergic
Receptors
Acetylcholine
Pathophysiology of
Urinary Incontinence
Bladder Physiology
Storage and Voiding




Bladder fills when sympathetics
cause Detrusor relaxation with
closed internal sphincter with
inhibition of parasympathetics
Bladder empties when
parasympathetics cause Detrusor
contraction, overides sympathetic
control of internal sphincter,
somatic opens external sphincter
Micturition reflex triggered when
pressure exceeds 20-40 cm H2O



Malfunction at any level - bladder, urethra, sphincter, CNS,
PNS
Disturbances in filling/emptying may lead to urge and stress
incontinence
Interruption with emptying can cause urinary retention and
overflow incontinence
Various CNS abnormalities leading to derangements in
inhibitory pathways can cause detrusor instability
8. Wein A. Neuromuscular dysfunction of the lower urinary tract and its treatment. Campbell’s Urology. 2002
7. DeMaagd G, Geibig J. Pharm Thera 2006:31(8): 462-474.
Nervous System
Categories of Incontinence Medications

Antimuscarinics





Tolterodine
Trospium
Darifenacin
Solifenacin
Central Nervous System
(CNS)
Adrenergic agonists



Ephedrine
Phenylpropanolamine
Imipramine


Brain
Spinal Cord
Peripheral Nervous System
(PNS)


Afferent Division
Efferent Division



Agents with multiple actions




Oxybutynin
Propiverine
Dicyclomine HCL
Flavoxate HCL

Miscellaneous




Somatic System (voluntary)
Autonomic System (involuntary)

Tricyclic antidepressants
Botulinum Toxin
Capsaicin (not available in the US)
RTX (not available in the US)
Sympathetic



Parasympathetic





Muscarinic/Cholinergic
Receptors
Acetylcholine
Peripheral Nervous System
Blocking Parasympathetic System

Alpha and Beta Receptors
Epinephrine/Norepinephrine
At least 5 muscarinic receptor subtypes exist (M1-5)
M1, M2, M3 identified to be present on bladder
For antimuscarinic meds, tissue selectivity has greater
impact than subtype selectivity in minimizing side
effects
β1, β2 and β3 receptors are found in smooth muscle
of bladder
9. Silva W. Pharmacologic management of incontinence and voiding dysfunction. J Pelvic Med Surg 2005;11:1-37
10. Lippincott’s Pharmacology 5th Ed 2011
25
Receptor Types with Effects of Anticholinergic Blockage
Antimuscarinic Agents
Organ System
Receptors
Salivary Glands
M1, M2, M3
Dry mouth
Cardiac Tissue
M2
Tachycardia, Palpitations
Eye (ciliary muscle, iris)
M3, M5
Dry eyes, Blurred vision
GI Tract
M1, M2, M3
Prolonged transit time
(constipation), Gastric acid
secretion

Effects on memory, Confusion,
Hallucinations, Sleep
disturbance, Retarded
psychomotor speed

CNS (cortex and hippocampus)
Bladder (detrusor muscle)
M1, M2, M3, M4, M5
M1, M2, M3
Effects of Blockage
Current
Historic

Atropine Sulfate
Emepronium Bromide
Scopolamine




Tolterodine
Trospium
Darifenacin
Solifenacin
Decreased contraction, Urinary
retention
7. DeMaagd G, Geibig J. Pharm Thera 2006:31(8): 462-474.
24. Andersson KE. Antimuscarinics for treatment of overactive bladder. Lancet Neurol 2004;3:46–53.
25. Gormley EA, Lightner DJ, Burgio KL, et al. Urol. 2012;188:2455-2463.
Antimuscarinic Agents
Tolterodine






Antimuscarinic Agents
Trospium
Tertiary amine
Non-specific competitive M-receptor blocker
First antimuscarinic agent specifically targeted to combat
bladder overactivity
Multiple randomized clinical trials available
Decreases number of micturition per 24 hrs, incontinence
episodes, frequency and urgency symptoms, increase void
volume
Available as immediate-release (1-2 mg bid) and extended
(2 mg or 4 mg q day)







9. Silva W. Pharmacologic management of incontinence and voiding dysfunction. J Pelvic Med Surg 2005;11:1-37
11. Madersbacher H, Stohrer M, Richter R, et al. Trospium chloride versus oxybutynin: a randomized, double-blind,
multicentre trial in the treatment of detrusor hyper-reflexia. Br J Urol. 1995;75:452-456.
9. Silva W. Pharmacologic management of incontinence and voiding dysfunction. J Pelvic Med Surg 2005;11:1-37
Antimuscarinic Agents
Darifenacin





Quaternary amine
Atropine-like non-selective M-receptor blocker (M1-5)
Over 20 clinical trials documenting improving detrusor
instability and hyperreflexia
Low incidence of side effects
Poor bioavailability (must be taken on empty stomach)
Appears to be tissue specific
Immediare release (20 mg bid) or extended (60 mg q am)
Antimuscarinic Agents
Solifenacin
Highly selective M3 receptor blocker
Selectivity allows for less adverse side effects
Once a day dosing (7.5 mg or 15 mg)
Significant reduction in urinary incontinence, frequency and
urge
Causes less dry-mouth symptoms than Oxybutynin



9. Silva W. Pharmacologic management of incontinence and voiding dysfunction. J Pelvic Med Surg 2005;11:1-37
12. Newgreen DT, Anderson DP, Carter AJ. Neurourol Urodyn 1995;14:95
13. Ebinger U. Poster 4029. Abstract in the 17th World Conference of Family Doctors, 2004
Great tissue selectivity for the bladder
First antimuscarinic statistically significant showing reductions
in urgency episodes per 24 hours in multiple trials
Once a day dosing (5 mg or 10 mg )
9. Silva W. Pharmacologic management of incontinence and voiding dysfunction. J Pelvic Med Surg 2005;11:1-37
14. Hatanaka T, Ukai M, Ohtake A, etal. International Continence Society Meeting, 2003
15. Lucente V, Swift S. AUGS/SGS Joint Scientific Meeting Abstracts, 2004
26
Agents with Multiple Actions
Oxybutynin
Agents with Multiple Actions




Oxybutynin
Propiverine
Dicyclomine
Flavoxate







Tertiary amine with anticholinergic antagonism, myotrophic
relaxation, local anesthesia
Used as the gold standard for overactive bladder for more than
30 years
Possesses some degree of selectivity for M1 and M3 receptors
Immediate release has short half-life (2.5 to 5 mg bid-tid)
Extended release (5, 10, 15 mg once a day)
Transdermal patch (1 patch twice/week) avoids first-pass
Topical ointment and gel
9. Silva W. Pharmacologic management of incontinence and voiding dysfunction. J Pelvic Med Surg 2005;11:1-37
16. Thuroff JW, Chartier-Kastler E, Corcus J, et al. World J Urol 1998;16(suppl 1):s48
Agents with Multiple Actions
Propiverine






Agents with Multiple Actions
Dicyclomine
Tertiary amine
Predominantly with anticholinergic activities
Secondary effects on myotropic relaxation
Nine randomized controlled trials available
Studies included patients with detrusor instability and
hyperreflexive detrusor function
Not currently available in the U.S.
Tertiary amine
Posseses both anticholinergic and relaxant effects on smooth
muscle
Only few randomized trials available
Several studies demonstrated favorable results in detrusor
activity
Used more often to treat Irritable Bowel Syndrome due to
relaxation effects on smooth muscle as anti-spasmotic
20-40 mg po qid






9. Silva W. Pharmacologic management of incontinence and voiding dysfunction. J Pelvic Med Surg 2005;11:1-37
17. Halaska M, Dorschner W, Frank M. Neurourol Urodyn. 1994;13:428-430.
9. Silva W. Pharmacologic management of incontinence and voiding dysfunction. J Pelvic Med Surg 2005;11:1-37
18. Castleden CM, Duffin HM, Millar AW. Clin Exp Gerontol. 1987;9:265-270.
Agents with Multiple Actions
Flavoxate






Adrenergic agonists
Tertiary amine
Myotropic relaxant
Weak anticholinergic effect
Many studies showed limited effect on detrusor activity
International Continence Society does not recommend
common usage due to lack of encouraging data
100-200 mg po Tid-Qid




α/β-adrenergic stimulation keeps the internal sphincter
contracted
Several agonist-based medications showed enhanced bladder
outlet resistance
Numerous side effects (hypertension, anxiety, headache,
insomnia, arrhythmia) has led to limited usage
Ephedrine, Pseudoephedrine, Phenylpropanolamine,
Imipramine
9. Silva W. Pharmacologic management of incontinence and voiding dysfunction. J Pelvic Med Surg 2005;11:1-37
8. Wein AJ. Neuromuscular dysfunction of the lower urinary tract and its treatment. In: Campbell’s Urology. 8th ed.
Philadelphia, PA: WB Saunders; 2002.
9. Silva W. Pharmacologic management of incontinence and voiding dysfunction. J Pelvic Med Surg 2005;11:1-37
19. Andersson KE, Appell R, Cardozo LD, et al. BJU Int. 1999;84:923-947.
27
Miscellaneous
Miscellaneous


Capsaicin and Resiniferatoxin (RTX)
Tricyclic Antidepressants (primarily Imipramine) possess
systemic anticholinergic activity/inhibits
serotonin/noradrenaline reuptake; works well in elderly
patients with doses up to 150 mg/day
Botulinum Toxin (BTX) – 7 different toxins (A-G) causes
temporary paralysis; BTX-A used to treat DSD; effects last 39 months; 200-300 units over 20 points avoiding Trigone;
urinary retention is a risk




DSD – Detrusor Sphincter Dyssynergia

9. Silva W. Pharmacologic management of incontinence and voiding dysfunction. J Pelvic Med Surg 2005;11:1-37
21. Harper M, Fowler CJ, Dasgupta P. Botulinum toxin and its applications in the lower urinary tract. BJU Int. 2004;93:702-706.
22. Schurch B, Hauri D, Rodic B, et al. Botulinum-A toxin as a treatment of detrusor sphincter dyssynergia: a prospective study in 24
spinal cord injury patients. J Urol. 1996;155:1023-1029.
9. Silva W. Pharmacologic management of incontinence and voiding dysfunction. J Pelvic Med Surg 2005;11:1-37
23. Szallasi A, Blumberg PM, Vanilloid (capsaicin) receptors and mechanisms. Pharmacol Rev. 1995;51:159-211.
24. Kim JH, Rivas DA, Shenot PJ, et al. J Spinal Cord Med. 2003;26:358-363.
References
Most Commonly Used Antimuscarinic Agents to Treat Overactive Bladder
Oxybutynin
Tolterodine
Trospium
Ditropan, Ditropan
XL, Oxytrol
Solifenacin
1.
2.
Darifenacin
Detrol, Detrol LA
Sanctura
Sanctura ER
Vesicare
Enablex
Chemical
Structure
Tertiary amine
Tertiary amine
Quaternary
amine
Tertiary amine
Tertiary amine
Receptor
binding
Non-selective
Non-selective
Non-selective
Non-selective
May be more
M3 selective
Oral
bioavailability
Poor (3-15%)
Good (75%)
Poor (5%) Taken
on empty stomach
Good (90%)
Poor (15-20%)
Metabolism
CYP 3A4
CYP 2D6
CYP 450
CYP 3A4
CYP 2D6 and
3A4
Excretion
Less than 5% active
compound in urine
Less than 5%
active compound
in urine
Tubular secretion
80% parent
compound in
urine
Less than 15%
parent compound
in urine
3% active
compound in
urine
Half-life
2 Hrs/13 Hrs
8 Hrs
2 Hrs/9 Hrs
12-20 Hrs
45-65 Hrs
13-19 Hrs
Dosing
5 mg bid-tid
5-30 mg q day
3.9 mg 2x/week
1-2 mg bid
2-4 mg q day
20 mg bid
60 mg q day
20 mg q day
(elderly/renal )
5-10 mg daily
7.5-15 mg daily
Both belong to the Vanilloid family; extracted from chili peppers
and cactus-like plant respectfully which interferes with neuronal
pain fibers
Vanilloids are ligands of vanilloid receptor type 1 (VR1); both
inhibits the release of substance P and cause down-regulation on the
bladder
Intravesical administration causes improvement in neurogenic urge
incontinence and other irritative voiding syndromes
Used as topical pain relievers currently
Not available for incontinence usage in the U.S.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
7. DeMaagd G, Geibig J. Pharm Thera 2006:31(8): 462-474.
24. Andersson KE. Antimuscarinics for treatment of overactive bladder. Lancet Neurol 2004;3:46–53.
25. Gormley EA, Lightner DJ, Burgio KL, et al. Urol. 2012;188:2455-2463.
24.
25.
Thank You
28
Swift SE. Epidemiology of pelvic organ prolapse and urinary incontinence. In: Bent AE, Cundiff GW, Swift SE, eds. Ostergard’s
Urogynecology and Pelvic Floor Dysfunction. 6th ed. Philadelphia: Wolters Kluwer-Lippincott; 2008: 27-38.
Abrams P, Cardozo L, Fall M, et al. The standardization of terminology in lower urinary tract function: report from the Standardization
Subcommittee of the International Continence Sciety. Urology 2003;61:37-49.
Cucchi A, Siracusano S, Guarnaschelli C, et al. Voiding urgency and detrusor contractility in women with overactive bladders. Neurourol
Urodyn 2003;22:223-226.
Culligan PJ. Nonsurgical management of pelvic organ prolapse. Obstet Gynecol 2012; 119 (4):852-860.
Pott-Grinstein E, Newcomber JR. Gynecologists’ pattern of prescribing pessaries. J Reprod Med 2001;46:205-208.
Schaffer J, Rahn DD, Wieslander CK. Overview of Treatment. In: Bent AE, Cundiff GW, Swift SE, eds. Ostergard’s Urogynecology and
Pelvic Floor Dysfunction. 6th ed. Philadelphia: Wolters Kluwer-Lippincott; 2008: 454-462.
DeMaagd G, Geibig J. An overview of overactive Bladder and its pharmacological management with a focus on anticholinergic drugs. Pharm
Thera 2006:31(8): 462-474.
Wein A. Neuromuscular dysfunction of the lower urinary tract and its treatment. In: Campbell’s Urology. 8th ed. Philadelphia: WB Saunders;
2002.
Silva W. Pharmacologic management of incontinence and voiding dysfunction. J Pelvic Med Surg 2005;11:1-37.
Cholinergic antagonists. In: Harvey RA, Clark MA, Finkel R, et al. Pharmacology. 5th ed. Philadelphia: J.B. Lippincott; 2011: 50-61.
Madersbacher H, Stohrer M, Richter R, et al. Trospium chloride versus oxybutynin: a randomized, double-blind, multicentre trial in the treatment
of detrusor hyper-reflexia. Br J Urol. 1995;75:452-456.
Newgreen DT, Anderson DP, Carter AJ. Darifenacin: a novel bladder-selective agent for the treatment of urge incontinence. Neurourol Urodyn
1995;14:95.
Ebinger U. Darifenacin versus oxybutynin for overactive bladder. Poster 4029. Abstract in the 17th World Conference of Family Doctors,
Orlando, 2004.
Hatanaka T, Ukai M, Ohtake A, etal. In vitro tissue selectivity profile of solifenacin succinate (YM905) for urinary bladder over salivary gland in
rats and monkeys International Continence Society Meeting, 2003.
Lucente V, Swift S. AYM-905 Study Group. Urgency episodes were statistically significantly reduced with solifenacin treatment for overactive
bladder. AUGS/SGS Joint Scientific Meeting Abstracts, San Diego, 2004.
Thuroff JW, Chartier-Kastler E, Corcus J, et al. Medical treatment and medical side effects in urinary incontinence in the elderly. World J Urol.
1998;16(suppl 1):s48.
Halaska M, Dorschner W, Frank M. Treatment of urgency and incontinence in elderly patients with propiverine hydrochloride.
Neurourol
Urodyn. 1994;13:428-430.
Castleden CM, Duffin HM, Millar AW. Dicyclomine hydrocholride in detrusor instability: a controlled clinical study. J Clin Exp Gerontol.
1987;9:265-270.
Andersson KE, Appell R, Cardozo LD, et al. The pharmacological treatment of urinary incontinence. BJU Int. 1999;84:923-947.
Harper M, Fowler CJ, Dasgupta P. Botulinum toxin and its applications in the lower urinary tract. BJU Int. 2004;93:702-706.
Schurch B, Hauri D, Rodic B, et al. Botulinum-A toxin as a treatment of detrusor sphincter dyssynergia: a prospective study in 24 spinal cord
injury patients. J Urol. 1996;155:1023-1029.
Szallasi A, Blumberg PM, Vanilloid (capsaicin) receptors and mechanisms. Pharmacol Rev. 1995;51:159-211.
Kim JH, Rivas DA, Shenot PJ, et al. Intravesical resiniferatoxin for refractory detrusor hyperreflexia: a multicenter, blinded, randomized,
placebo-controlled trial. J Spinal Cord Med. 2003;26:358-363.
Andersson KE. Antimuscarinics for treatment of overactive bladder. Lancet Neurol 2004;3:46–53.
Gormley EA, Lightner DJ, Burgio KL, et al. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU Guideline. J
Urol. 2012;188:2455-2463.
Evolution of Surgical
Management of Incontinence:
Disclosure
Robert T O’Shea
I have no financial relationships to
FRANZCOG
disclose.
Flinders Endogynaecology / Urogynaecology
Flinders University & Flinders Medical Centre
Adelaide, Australia
Objectives
Treatment Guidelines
(AUA 2010)
At the conclusion of this activity the participant should be able to:
1. Stress incontinence procedures may be considered in patients with
mixed incontinence and significant stress incontinence
1. List the predominant surgical procedures used in the
2. Patients with urge incontinence without SUI should not be offered a
surgical procedure for SUI
treatment of stress incontinence over the past 30
years.
3. Surgical procedures for SUI and prolapse may be safely performed
together. Tensioning of sling should not be performed until prolapse
surgery completed
2. List and compare the benefits and drawbacks of
various surgical procedures for stress incontinence.
4. Intraoperative cystourethroscopy should be performed in all patients
undergoing sling surgery
3. List and compare RPMUS and TOT in the treatment
Dmochowski et al (2010) [1]
of stress incontinence.
Timeline of significant surgical
procedures for stress incontinence
Timeline Of Significant Surgical
Anterior repair:
Procedures For Stress
• Schultz 1879 – anterior repair
• Kelly plication 1913 – wedge of tissue
Incontinence
to support ureterovesical junction
• Ingelman Sundberg 1951 – 1952 bulbocavernosus
Rock et al (2008) [2]
29
Timeline of significant surgical
procedures for stress incontinence
Timeline of significant surgical
procedures for stress incontinence
Sling:
Sling:
• Von Giordano, 1907 – gracilis muscle
• Goebell 1910 – pyramidalis muscle
• Frangenheim 1914 – abdominal wall
fascia with pyramidalis
• Stoeckel 1917 – same as Frangenheim
• Price 1933 – fascia lata
• Aldridge 1942 –rectus fascia
• Ridley 1974 – description of sling in textbook
• Zoedler 1961 – gauze hammock synthetic sling
Paravaginal repair:
• White 1909 – original description
• Richardson 1981 – renewal of White technique
Timeline of significant surgical
procedures for stress incontinence
Timeline of significant surgical
procedures for stress incontinence
Needle suspension:
• Pereya 1959
• Stamey 1973
• Raz 1981
• Gittes 1987
Retropubic:
• Marshall-Marchetti-Krantz 1949
• Burch 1968
• Tanagho 1976 – Burch modification
Periurethral bulking
• McGuire 1994 – Contigen injection
• Vancaillie 1991 – laparoscopic Burch
Timeline of significant surgical
procedures for stress incontinence
Inpatient Urinary Incontinence Surgery
USA
Tension-free synthetic tape
• Ulmsten and colleagues 1996 – TVT
(tension-free tape)
1998-2007
1998
2007
Retropubic suspensions
52.3%
13.8%
Other repair of SUI
22.4%
75.2%
• DeLorme 2001 –Transobturator tensionfree tape
Wu et al (2011) [3]
30
Stress Urinary Incontinence
SISTEr Trial (Albo et al 2007) [4]
Burch Colposuspension
Longterm Data
Alcalay et al (1995)
[5]
Success – declined for 10-12 years
(n=109)
plateau 69% success
(⅓ repeat cont surgery)
Kjolhede (2005)
[6]
(n=190)
14 year follow up
- signif urinary incontinence – 56%
- no incontinence episodes – 19%
Petros PE, Ulmsten UI (1990)[ 7 ]
Midurethral Tapes vs Burch
Integral Theory of Incontinence
Novara
(2010) [8]
Midurethral Tapes
31
Cure rates (objective)
Increased
Cystotomy
Increased
Burch
Suburethral Sling vs Lap Colposuspension
Cochrane (2010)
(Cochrane 2010)
8 Studies
Midurethral Sling
Efficacy
Pubovaginal Sling
Equivalent
Equivalent
3 Abstracts
(n = 33-133)
Follow up 12 m
(6-24)
Cure / improvement – conflicting evidence
 Operating time
 Voiding dysfunction
 Denovo urgency
Sling
Ogah et al (2010) [9]
 urgency (de novo)
 urgency
 UI
 operating time
 hospital stay
 RTW
QOL – No significant difference
TOMUS (Richter et al 2010) [10]
TOMUS (Richter et al 2010) [10]
n = 597
n = 597
Treatment success 12 months
RPMUS
TOT
81%
78%
• Neg stress test
Success
• Neg pad test
Perforation

Voiding difficulty

• Absence symptoms
• No leakage
Groin pain

Vaginal erosion

• No retreatment
Suburethral Sling
RPMUS vs TOT
(Cochrane 2010)
17 Trials
(n = 2434)
Transobturator
Cure
84%
88%
Subjective cure
83%
83%
Voiding dysfunction
4%
7%
0.3%
5.5%
Cystotomy
ISD
Retropubic
RPMUS
TOT
+
-
Ureteric Hypermobility
Mod ISD
No Detrusor storage abn
Healthy vaginal wall
RPMUS applies more urethral pressure (ISD)
Winters JC et at 2012 [11]
32
RPMUS vs TOT
TVT vs TOT
SUMMARY
RPMUS
TVT
Low UPP
+
ISD
+
Absence urethral
hypermobility
TOT
Less effective
•
TVT Robust data > 16yrs
•
↑ Efficacy for SUI
•
Haematoma (retropubic), cystotomy, voiding dysfunction, OAB.
TOT
 failure
Liopis A, et al (2004) [12]
Lo TS et al (2002) [13]
•
Equivalent SUI
•
Reduced OAB
•
Reduced groin pain
TVT – Longterm data
Nilsson et al 2013 [14]
TVT – Longterm data
n = 90
• Follow up 17 years
Svenningsen et al 2013 [15]
• TVT (1998–2000)
(78% clinic/telephone)
(n = 603)
(f/u 483)
• 3 Nordic centre
• Objective continence
• 4 Norway centres
>90%
• Subjective cure/improve
78%
• Objective cure
89.9%
• Subjective cure
76.1%.
Minislings vs Standard MUS
Monarc vs Miniarc
Meta-analysis
RCT (Monash-12m)
9 RCT’s (n=758)
Follow-up 10m
•
Lower subjective/objective cure rates
•
Decreased operating time
•
Decreased groin pain
•
Increased repeat surgery
Abdel-Fattah et al 2011[16]
33
Monarc
Miniarc
Subjective Cure
94%
92%
Objective Cure
96%
94%
OAB (medication)
15%
5.7%
Groin Pain
7%
0
Intrinsic Sphincter Deficiency
Pelvic Organ Prolapse
RPMUS vs TOT (RCT)
To Sling or not to Sling (RCT)
USI plus ISD
(MUCP < 20)
POP + TVT
n=37
(LPP < 60)
POP w/o TVT
n=43
Required repeat surgery (USI)
RPMUS
TOT
6.1%
19.9%
10 TVT’s to prevent 1 SUI (postop)
Schierlitz et al (2008) [17]
Schierlitz et al (2008) [17]
Stress Incontinence
Stress Incontinence
Urethral bulking agents
Urethral bulking agents
Biological
Synthetic
• Silicone particles (MacroplastiqueTM)
FDA
• Calcium hydroxylapatite (CoaptiteTM)
Mechanism
• Porcine dermis (Permacol )
• Mechanical support to bladder neck
•
FDA
TM
• Glutaraldehyde cross-linked bovine collagen (ContigenTM)
Increased urethral resistance
• Carbon beads (DurasphereTM)
• Polyacrylamide hydrogel (Bulkamid ® )
Stress Incontinence
Conclusion
Urethral bulking agents
Incontinence Surgery Evolution
• SUI – Primary & secondary
• Cure < surgery
1879-2013
Laparotomy – Laparoscopy – RPMUS
Stress Urinary Incontinence (SUI)
»
»
»
»
Contigen – cure 53%
Bulkamid – cure 64% (2m)
Gold Standard = Midurethral Sling
TVT vs TOT
Mini Slings
Urethral bulking agents
Prolapse/SUI
» Adjunctive prolapse procedure
Davis NF, et al (2013) [18]
34
(Vag or laparoscopic)
References
References
1.
Liopis A, Bakas P, Lazaris D et al. Tension-free vaginal tape in the management of recurrent stress
incontinence.Arch Gynecol Obstet (2004); 269 (3): 205-7.
Rock JA, Jones HW, “Te Linde’s Operative Gynecology” Tenth Edition, Wolters Kluwer, Lippincott Williams & Wilkins,
13.
14.
15.
N Engl J Med (2007); 356(21) : 2143-55
Alcalay M, Monga A, Stanton SL. Burch colposuspension: A 10-20 year follow up Br J Obstet Gynaecol 102 (9): 740-745
6.
Kjolhede P. Long-term efficacy of Burch colposuspension: A 14 year follow up study. Acta Obstet Gynecol Scand 84(8):
Schierlitz L, Dwyer P, Rosamilia A. Effectiveness of Tension-Free Vaginal tape compared with
Transobturator Tape in women with Stress Urinary Incontinence and Intrinsic Sphincter Deficiency.
Novara G, Artibani W, Barber MD, et al. Updated systemic review and meta-analysis of the comparative data on
Obstet Gynecol (2008) 112:1253-67.
18.
Urol (2010); 58(2) : 218-38.
10.
meta-analysis of effectiveness and
complications. European Urology (2011) 60;468-480.
17.
colposuspensions, pubovaginal slings, and midurethral tapes in the surgical treatment of female stress incontinence. Eur
9.
Abdel-Fattah M, Ford J, Lim C et al. Single incision mini slings vs standard midurethral slings in
surgical management of female stress urinary incontinence:
Petros PE, Ulmsten UI. An integral theory of femal urinary incontinence; experimental and clinical considerations. Acta
Obstet Gynecol Scand (1990); 69 Suppl 153:7-31.
8.
Svenningsen R, Staff A, Hjalmar A et al. Long-term follow up of the retropubic tension-free vaginal
tape procedure. Int Urogynaecology (2013); 24:1271-1278.
16.
767-772.
7.
Nilsson CG, Palva K, Aarnio R, et al. Seventeen years follow-up of the tension-free vaginal tape
procedure for female stress urinary incontinence. Int Urogynaecology J (2013); 24:1265-1269
Albo ME, Richter HE, Brubaker L, et al Burch colposuspension verses facial sling to reduce urinary stress incontinence.
5.
Lo TS, Horng SG, Chang CL et al. Tension-free vaginal tape procedure after previous failure in
incontinence surgery. Urology 2002; 60: 57-61.
Wu J M, Gandhi M P, Shah A D et al. Trends in inpatient urinary incontinence surgery in the USA, 1998-2007. Int
Urogynaecol J (2011) 22:1437-1443.
4.
12.
selection. Can Urol Assoc J 2012;6(5):S118-9.
2008 p944.
3.
Winters JC. Surgical management of stress urinary incontinence: A rational approach to treatment
Dmochowski RR, Blaivas JM, Gormley EA, et al Update of AUA Guidelines of surgical management of stress
incontinence. J UROL (2010); 183(5) : 1906-14
2.
11.
Davis NF, Kheradmand F, Creagh T. Injectable biomaterials for the treatment of stress urinary
Ogah J, Cody JD, Rogerson L. Minimally invasive synthetic suburethral sling operations for stress urinary incontinence in
incontinence: their potential and pitfalls as urethral bulking agents. Int Urogynaecol J (2013); 24:913-
women (review) The Cochrane Collaboration 2010 Issue 1.
919.
Richter HE, Albo ME, Zyczynski HM, et al. Retopubic verses transobturator midurethral slings for stress incontinence. N
Engl J Med 2010:362(22):2066-76.
35
Disclosures
Does She Have Prolapse?
Obliterative or Reconstructive
Surgery


VincentLucenteMD,MBA

MedicalDirector,TheInstitutefor
FemalePelvicMedicineand
ReconstructiveSurgery
ChiefofGynecology,St.Luke’sHospital
ClinicalProfessorOb/Gyn Temple
Objectives

Grants/Research Support: American Medical Systems,
Bard Medical Division, Kimberly-Clark
Consultant: Allergan, American Medical Systems, Bard
Medical Division, Kimberly-Clark
Speakers Bureau: Allergan, American Medical Systems,
Bard Medical Division
Pelvic Organ Prolapse
By the end of this lecture you:
Should learn the components of pelvic organ prolapse in terms of distension vs. detachment
 Should be able to do POPQ staging
 Should learn the different surgical treatment options available and effectively council patients in order to facilitate shared decision making and selection of the most appropriate surgery for them
 Should learn the risks and benefits of synthetic graft augmented reconstructive pelvic surgery

“The Uterus is Falling”
POP/ Native Tissue
What Causes POP?




Multiple studies confirm that women with POP
have a Genetic predisposition
Exact causes unknown, but likely multifactorial
Defective genital support response to ‘normal’
intra-abdominal forces or ‘normal’ supports
chronically subjected to high intra-abdominal
forces
Risk factors can be classified as: predisposing,
inciting, promoting, or decompensating events
Established vs. Potential Risk Factors
Uterosacral ligament biopsies
with prolapse
Chen BH et. al. Int Urogyn J 2006;17(Suppl 3):S409
Weislander CK et.al. Int Urogyn J 2006;17(Suppl 3): S406-7
Gabiel B et.al. Int Urogyn J 2006;17(5):478-82
Jack GS et.al. Int Urogyn J 2006;17(5):498-501
Phillips CH et.al. BJOG 2006;113(1):39-46
Ozdegirmenci Oet.al. Int Urogyn J 2005;16(1):39-43
Poncet S et.al. Am J Obstet Gynecol 2005;192(2):426-32
Soderberg MW et.al. Acta Obstet Gynecol 2004;83(12)1193-8
Wong MY et.al. Am J Obstet Gynecol 2003;189(6):1597-9
Boreham MK et.al. Am J Obstet Gynecol 2002;187(1):56-63
Goepel C et.al. Acta Obstet Gynecol Scan 2003;82(7):659-64
36
without prolapse
Visco AG et.al. Am J Ostet Gynecol 2003;189(1):102-12
Chen B et.al.Neurourol Urodyn 2004;23(2):119-26
Goh JT Cur Op Obstet Gynecol 2003;15(5):391-4
Ewies AA et.al. H Repro 2003;18(10):2189-95
Takano CC et.al. Int Urogyn J 2002;13(6):342-5
Kokcu A et.al. Arch Gynecol Obestet 2002;266(2):75-8
Liapis A et.al. Eur J Obstet Gynecol 2001;97(1):76-9
Yamamoto M et.al. Cell Biol Int 1998;22(1):31-40
Jackson SR et.al. Lancet 1998;347(9016):1658-61
Jackson SR et.al. Lancet 1998;347(9016):1658-61
Stanosz S et.al. Ginekol Pol 1995;66(9):518-22
Established and Potential Risk
Factors for Pelvic Organ Prolapse


Established risk factors
3.
Vaginal delivery
Advancing age
Obesity

Potential risk factors
1.
Obstetric factors
Family history POP
Race
Connective‐tissue disorders/ genetic factors
Constipation, chronic straining or heavy lifting
Previous Hyst, (especially w/o concurrent culdoplasty)
1.
2.
2.
3.
4.
5.
6.
Background



Pelvic Organ Prolapse Prevalence




Demographic factors and changing patient
expectations …‘50 is the new 40’
Next 30 yrs the rate of women who will seek
treatment for POP will double
POP is the ‘indication’ for approx 7-14% of all
hysterectomies for benign disease
Annual number of corrective surgeries and
related health care costs will no doubt rise
POP Procedural Demand
POP in > 50% of women over 501
Lifetime prevalence of 30-50%1
Women > 65 is the fastest growing segment
of the US population2
Demand for services expected to double in
the next 30 years3





11% risk of surgical intervention by age 801
226,000 procedures performed in 19972
Cost > 1 billion3
Estimated number in 2030 is 7 million4
Represents a small subset of symptomatic
patients
1Olsen
2 Brown
2US
3Subak
LL et.al. Obstet Gynecol 2001;98:646-51
Census Bureau 2000 Int data base
3Luber KM et.al. Am J Obstet Gynecol 2001;184:14961501
51
4Shull B Am J Ob Gyn 1999;181:6-11
POP Location1







et.al. Obstet Gynecol 1997;89:501
JS et.al. Am J Ob Gyn 2002;186:712
LL et.al. Obstet Gynecol 2001;98:646-
1Subak
DeLancey Levels of Support
Anterior only40%
Anterior and apex20%
Posterior only7%
Posterior and apex10%
All three compartments18%
Anterior compartment involved78%
Highest failure in Ant. Compartment
Olsen A et.al. Obstet Gynecol
reported from 30-70% 2,3,4,5,6 1997;89:501




’92
’95
4Samuelsson
5Shull
Paravaginal attachments‐
paracolpium
Distal Fusion (DeLancey level III)

3Holley
Cardinal/U.S. “ligament” complex
Lateral Attachment
(DeLancey level II)

1
2Shull
Apical Suspension
(DeLancey level I)
Perineal membrane/body
’99
’00
‘01
DeLancey, JO Am J Ob Gyn 1992;
166:1717
6Weber
37
Detachment vs. Distention
Support Structures
Detachment-
Intact vaginal fibromuscular envelope
Separated from supporting structures
 Allows descent (prolapse) of the intact envelope with over
or underlying organs into the vaginal cavity
Distention Defect within the vaginal fibromuscular envelope itself
 Remains attached to supporting structures
 Allows herniation of the over/underlying organs in direct
contact with vaginal epithelium into the vaginal cavity

Cardinal/Uterosacral Complex

Paracervical Ring
Arcus Tendineus Fascia Pelvis
ATFP
Fascia Endopelvina (paracolpos)
Pubocervical “fascia”
Rectovaginal “fascia”
Detachment
Pubourethral “ligaments”
Distention
Distension
Loss of Apical support
Detachment vs. Distention
Vaginal Vault Detachment
Vaginal Vault Detachment
and Distention
Complete U‐V Prolapse

Uterosacral ligament detached from pericervical ring at level of ischial spines

Upon valsalva, lateral fornices bulge due to detachment from cardinal ligament

With progression antero‐lateral sulci collapse as lateral detachment from the ATFP ensues

Cervical elongation has been observed with uterine prolapse, may need to consider when performing uterine preservation RPS

In post‐hyst vault prolapse, enterocele formation is more common
Cystocele
38
Anatomic Considerations
Anterior Compartment
Lateral Detachment Defect ?
Detachment Cystoceles
Distention Cystoceles
A Cullen Richardson
Rectocele
Pelvic Organ Prolapse
Do you “POP-Q”?
ICS Pelvic Organ Prolapse Ordinal Grading/Staging System (POP‐Q)
Halfway system for Grading

Urethrocele, cystocele, uterine prolapse,
rectocele: (while straining)
Grade 0:
Grade 1:
Grade 2:
Grade 3:
Grade 4:



normal position
descent halfway to the hymen
descent to hymen
descent halfway past the hymen
maximum possible descent


Stage 0
Points Aa, Ap, Ba, and Bp are all at -3 cm
and either point C or D is at no more than -(X-2) cm
Stage I
The criteria for stage 0 are not met and the
leading edge of prolapse is less than -1 cm
Stage II
Leading edge of prolapse is at least -1 cm but
no more than +1 cm
Stage III
Leading edge of prolapse is greater than +1
but less than +(X-2) cm
Stage IV
Leading edge of prolapse is at least +(X-2)
cm
X= total vaginal length in cms
39
40
Treatment Options
Simplified POP‐Q

Stage 1 – Prolapse at least 1 cm above hymenal ring
Stage 2 – Prolapse 1cm above to 1 cm below hymenal
ring
Stage 3 – Prolapse past introitus but not complete
eversion or procedentia
Stage 4 – Complete eversion or procedentia

Non-surgical options
- do ‘nothing’…serial observation
- pessary placement…sucessful long term
management can be challenging
- PME/kegels…may only slow progression
Surgical options: Obliterative vs Reconstructive
-Various ‘approaches’ (open, endoscopic, vaginal)
- Suture based native tissue repair vs graft placement
*If one segment is stage 4 then all are stage 4
Obliterative Procedures





Obliterative Procedures
“Colpocleisis” from the Greek kolpos = folds or hollow,
and cleisis = closure.
First reported in 1823 by Gerardin. Current technique is a
modification of that first described in 1877 by Leon
Lefort
High success rates >90%
Several retrospective cohort studies reported comparable
satisfaction after obliterative versus reconstructive surgery
Regret over the loss of the ability to have vaginal
intercourse has been reported in up to 13% of women
who had an obliterative procedure
Patient selection is crucial:






LeFort Colpocleisis
Age
No longer sexually active
Significant comorbidities
Advanced stage III – IV prolapse
Cervical and/or uterine pathology has been
excluded
Symmetry of the defect
Colpectomy
41
Quality of life and surgical satisfaction after
vaginal reconstructive vs obliterative surgery for
the treatment of advanced pelvic organ prolapse
Murphy et al. Am J Obstet Gynecol. 2008 May;198(5):573.
 Retrospective cohort study 90 pts following
reconstructive vs obliterative surgery
 Pre and Post operative responses to the UDI-6 and
IIQ-7 plus the Surgical Satisfaction Questionnaire
(SSQ-8) were analyzed.
 Improvements in condition-specific quality of life
and postoperative patient satisfaction measures are
comparable in women with prolapse who undergo
either reconstructive or obliterative surgery
Obliterative procedure
Prolapse
Obliterative procedure
Sequential closure
Separate into quadrants
Obliterative procedure
Final layer of sutures
Surgical Management Obliterative
Surgical Management - Obliterative
Colpectomy and Closure of the Genital Hiatus
Colpectomy and Closure of the Genital Hiatus
42
How have we done with ‘traditional’
Surgical Reconstruction for POP?





Possible Causes of Failure
11.2% lifetime risk of surgical intervention1
29-40% of reconstructive procedures require
surgical reintervention for failure within 3 years1,2
60% of recurrences are at the same site3
32.5% occur at a different site due to unmasking
of an occult support defect3
Reoperation is the “tip of the iceberg”
1Olson
Anatomic
Neurogenic/Myopathic
Tissue Factors (collagen content and structure)
Environmental Factors
Surgical Factors





Healing and “scarring” does not replace or
add tensile strength, thus failing to restore
or maintain normal anatomic position and
function over time

AL, et.al. Obstetrics and Gynecology 1997; 89:501-6
2
Marchionni M, et al. Journal of Reproductive Medicine 1999;44;679-84
3
Clark AL, et.al. American Journal of Obstetrics and Gynecology 2003;189:1261-67
CARE: Complications
ASC: the “Gold Standard”
STRENGTHS
Group
WEAKNESSES
Burch (n=153)
All SAE
56(42 pts) 36.6%
Longitudinal
Surgical SAE
Known
Ileus
outcome data
General Anesthesia
risks
Length of hospital stay
Low graft complication rates
Laparotomy morbidity
Pain
Concomitant hysterectomy access
Respiratory compromise
Satisfactory sexual outcome data
function
Small bowel obstruction
Ileus
Thrombosis
Incisional hernia
15 (9.8%)
22 (13.9%)
11.9%
11 (7.2%)
10 (6.3%)
6.8%
Inc. Hernia
3 (2%)
4 (2.5%)
2.3%
Wound Complications
5 (3.3%)
6 (3.5%)
3.5%
1.3%
8 (5.2%)
12 (7.6%)
6.4%
Recovery
Repeat surg. prolapse
2 (1.3%)
6 (3.8%)
2.3%
Cosmesis
Surg tx SUI
7 (4.6%)
15 (9.5%)
7.1%
Burch (n=117)
No Burch (n=133)
p value
- 8.0 + 1.5
- 8.2 + 1.3
.46
Ba
- 2.2 + 0.9
- 1.8 + 1.1
< .001
Bp
- 2 + 1.3
- 2.3 + 0.8
.006
*mean
Burch (n=117)
24 (20.5%)
1.3%
Other
Mesh/suture Erosion
C
Stage
0
2.6%
Ileus
CARE: Anatomic Outcomes
POP-q
Total
38.6%
Total Reop Rate
Bowel
Point*
No Burch (n=158)
64(49 pts) 40.5%
Minimally Invasive Revolution
Goals:
-Emulate the outcomes attained with ASC
-Lower the morbidity
-Improve the patient experience
+ SD
No Burch (n=133)
23 (17.4%)
Total
18.8%


I
43 (36.8%)
51 (38.6%)
37.6%
II
46 (39.3%)
57 (43.2%)
41.2%
III
4 (3.4%)
1 (0.8%)
2%
> II
50 (42.7%)
58 (44%)
43.2%

Laparoscopy-GA, learning curve, OR time, conversion
Robotic- enormous expense, ease of use, “cool factor” ?
Vaginal implantation




Mean POSQ-12 = 37.3/48
43
“Overlay” of standard repairs- failure & exposure
Unsecured- High rates of failure in high degree prolapse
Sutured- high complication rates
Tension-free securement- most promising
Who thinks anatomic cure is better
with TVM compared to NT?
My “Evolution”
In the Approach
to Pelvic Reconstruction
“Nonabsorbable synthetic graft use may improve anatomic outcomes of
anterior vaginal wall repair, but there are trade-offs” As early as 1996 (T. J.)

2005- Present
Increasing EvidenceBased Validation of
The Transvaginal Mesh
Approach
2005:
Transvaginal Mesh Techniques
continued to be developed and
refined
We do… SGS SRG CPG – November 2008

1990’s
Laparoscopic Approach:
Native and Augmented
*1996 Mesh vs Approach
1990:
Native Tissue… Vaginal vs.
Abdominal?

The FDA - July 2011: TVM…

The Cochrane Review - November 2011
“may provide an anatomic benefit compared to traditional POP repair”

“Native tissue anterior was associated with more anterior compartment
failures than polypropylene mesh” repairs.

The “Beginning” of Transvaginal Synthetic Mesh
Placement: TVT 1998
ACOG Committee Opinion 513 – December 2011

2003:
Trans-vaginal Approach to
mesh Augmentation in PRS
“Based on available data, transvaginally placed mesh may improve the
anatomic support of the anterior compartment compared with native tissue
repair”

Benefit Beyond Short-Term
Anterior Anatomy
Anatomic Outcomes - Anterior
Study
Hiltunen/Nieminen
2007, 2008, 2010
Sivaslioglu
2008
Nguyen
2008
Carey 2009
Withagen
2011
Altman 2011 Menefee+
2011
Sokol /Iglesia
2012 Halaska
2012 Number of
Patients
202
Compartment
Studied
Anterior
90
Length
(months)
12
24
36
12
Native Cure
Anatomic
62%
59%
59%
72%
P value
Anterior
Mesh Cure
Anatomic
93%
89%
87%
91%
76
12
Anterior
87%
55%
.005
139
12
194
Anterior & Posterior
All
81%
65.6%
0.07*
12
92.2%
44.9%
<.001
389
12
Anterior
82%
48%
<.001
99
24
Anterior
82%
42%
.002

65
12
All
53%
39%
0.30¥

168
12
All
83%
61%
.003*
+
<.001
<.001
<.001
<0.05

Recurrent Posterior Compartment Prolapse 20111
Multicenter (13 sites) RCT in Netherlands: 12 mo’s
F/up 186 of 194: Tx’d Ant=100, Post=106, Apic=88
 ≥ Stage 2 or repeat sx: 14/57 (25%) vs 2/49 (4%),
P=.003 in favor of synthetic mesh over NT



Correction of Apical Compartment Prolapse 20122
Multicenter (5 sites) RCT in Czech Republic: 12 mo’s
Overall success: 61% SSLS vs 83% TVM, P=.003
 Point C: -5 vs -6 cm proximal to hymen, P=.016
1Withagen
2Halaska
Benefit Beyond Short-Term
Anterior Anatomy


Trade-offs
Most RCT’s powered for objective cure at 1yr
Only 1 powered for 10 composite outcome

One unique risk: graft erosion
Average rate: 10.3% synthetic & 10.1% biologic1
 Site variation (0-100%)2 & experience (25%  2%)3

Multicenter (53) RCT of 389 Nordic women1
 Objective and Subjective success in 61% vs 35%
 No symptom of bulge at 1yr: 62% vs 75%, P<.001


MI et al. Trocar-guided mesh compared with conventional… recurrent prolapse. Obstet Gynecol 2011;117:24250.
M et al. A multicenter RCT comparing.. in..posthysterectomy vaginal vault prolapse. AJOG 2012;301.e1-e7.

Contraction?: TVL, chronic pain, dyspareunia
The 2010/11 Cochrane update + new literature reveals
10* RCT’s comparing TVM to NT:
 All but two measured change in TVL
 Four measured pelvic pain
 All but one measured dyspareunia

RCT of 202 women, 180 with 3yr f/up2
One yr: Symptom of vaginal bulge TVM < NT, P=.02
 Three yr: Anatomic recurrence: 41% vs 13%, P<.001
 Three yr: Symptom of bulge: 19% vs 10%, P=.07

1Abed
1Altman
D et al. Anterior colporrhaphy vs TVM for POP. NEJM 2011;364:1826-36.
K et al. Outcomes after anterior vaginal wall repair with mesh: RCT 3year f/up. AJOG 2010;235.e1-8.
H, et al. Incidence and management of graft erosion… a systematic review. IUJ 2011;22:789-98.
GR, et al. Use of Gynecare Prolift… 1-year outcome. IUJ 2011;22:869-77.
is an RCT of NT, synthetic, and biologic graft in anterior compartment.
2Vaiyapuri
2Nieminem
*One
44
Vaginal Length
Study
Hiltunen/Niemine
n
2007, 2008, 2010
Sivaslioglu
2008
Nguyen
2008
Carey 2009
Lopes
2010
Withagen
2011
Altman 2011 Menefee*
2011
Sokol /Iglesia
2012 Halaska
2012 Number of
Patients
202
Length
(months)
12,24,36
Compartment
Native TVL
Change
‐0.5
P value
Anterior
Mesh TVL
Change
‐0.4
90
12
Anterior
0
0
0.92
76
12
Anterior
‐1
‐1
NS
139
12
NR
NA
12
Anterior & Posterior
Posterior/Apical
NR
32
‐2.2
‐2.9
NS
194
12
All
0
0
0.21
Pelvic Pain
0.80
Study
389
12
Anterior
0
‐0.5
0.13
99
24
Anterior
NR
NR
NA
65
12
All
‐1
‐1
0.35
168
12
All
‐0.4
‐0.8
0.30
Sexual Health
Study
Hiltunen/Niemine
n
2007, 2008, 2010
Sivaslioglu
2008
Nguyen
2008
Carey 2009
Lopes
2010
Withagen 2011
Altman 2011 Menefee*
2011
Sokol /Iglesia 2012 Halaska 2012 Number of
Patients
202
Length
(months)
12, 24+, 36
Compartment
Anterior
Mesh
Sexual Health
Adverse Effect
18%
Compartment
Mesh
Pain
Native Tissue
Pain
P value
Sivaslioglu
2008
90
12
Anterior
2.2%
8.9%
NS
Withagen
2011
194
12
All
De Novo
7.5%
De Novo
4.0%
0.44
Altman
2011
389
12
Anterior
0.5%
0%
1.00
Halaska
2012
168
12
All
8.1%
5.5%
0.73
P value
• Mesh is clearly “needed” for long term success for
repair of apical/anterior defects
• New lighter, more elastic “hybrid” monofilament
meshes may offer even better post operative function
• Transvaginal delivery is minimally invasive, technically
easier than laparoscopic, and much more cost effective
than robotic
• Data although not robust, is rapidly growing with
several level I studies completed that when properly
performed, transvaginal delivery of the mesh is safe
and effective
NS
90
12
Anterior
De Novo Dyspn
4.6%
De Novo Dyspn
0%
ND
12
Anterior
De Novo Dyspn
9%
De Novo Dyspn
16%
0.67
139
12
Anterior & Posterior
Apical
De Novo Dyspn
16.7%
De Novo Dyspn
15.2%
0.46
ND
ND
NA
De Novo Dyspn
8%
De Novo Dyspn
10%
0.75
0.99
12
Length
(months)
Why is transvaginal mesh beneficial?
Native Tissue
Sexual Health
Adverse Effect
20%
76
32
Number of
Patients
194
12
All
389
12
Anterior
PISQ Improved
2.8 points
PISQ Improved
2.0 points
99
24
Anterior
De Novo Dyspn
7.1%
De Novo Dyspn
12.5%
NS
65
12
All
De Novo Dyspn
9.1%
De Novo Dyspn
21.4%
0.60
168
12
All
PISQ Improved
2.5 points
PISQ Improved
6.7 points
NS
FDA Public Health Notification
When is TVM not Beneficial?



The mesh (post inplant) has undesired
biomechanical properties
Patients are not properly and fully informed of
the risk and benefits of the TVM procedure
There is suboptimal execution of the surgery
* dissection
* delivery/placement
* setting/adjustment






Obtain specialized training specific to each tech.
Be vigilant for adverse events, especially erosion
Watch for complications assoc. with placement
Inform patients implantation is permanent, some
complications may require addn. surgery
Educate pts. Re: serious complications effect on QOL,
including possibly dysparunia
Provide pts. with copy of patient labeling from
manufacturer (if available)
www.fda.gov
45
Dedicated Office Consent
When Informed Consent Is Not Enough

With a lack of clear
guidelines for mesh use
and avoidance, emphasis
must be placed on
individual patient risk
assessment and open
counseling between the
patient and physician.
“The patient was advised regarding various surgical options
including abdominal, laparoscopic and vaginal approaches.
The risks and benefits of surgery using endogenous tissue only
versus the use of graft insertion (mesh) were fully reviewed.
The patient was informed of the potential for improved
durability (as long-term studies are still not available) and the
inherent risks of graft use including, but not limited to,
infection, erosion, and chronic inflammation, acute and
chronic pain, pain with intercourse, (both of which can be
refractory to treatment) fistula, disturbance in bowel or
bladder function, any of
Dedicated Office Consent (con’t)

DISSECTION
which may require additional surgery for the mesh revision.
The patient is aware of the relatively limited medical data
comparing native tissue repairs to transvaginal synthetic graft
repairs to date, and that some physicians consider their use to
be lacking in sufficient “scientific” medical evidence even
though FDA approved. The patient was advised regarding the
July 13, 2011 FDA notification regarding these issues and
provided the website address for further reference
www.fda.gov. The patient was provided a written copy of the
patient labeling from the surgical mesh manufacturer”.



The most “difficult” step in transvaginal mesh
delivery procedures
The make or break point for achieving a low
exposure rate
Can be extremely challenging in patients with
prior retro-pubic or para-vaginal dissection
Histology of Vaginal “Fascia”
The Importance of Depth
Mesh Exposure
}
Non-Keratinized Stratified
Squamous Epithelium
Directly fused on:
With ASC – 0.5% using polypropylene
 Vaginal Implantation – 3-19%

WHY???
Source: Bailey’s Textbook of Histology
Williams & Wilkins 1971
46
Thin Lamina Propria
Concentric Layers of
Smooth Muscle
Fibrous “Coat”
derived from
Dense Irregular
connective tissue
Endopelvic “Fascia”
Anterior
Vaginal Wall Anatomy
Surgical placement of Mesh
Iatrogenically bisected
vaginal wall
Compartment1
Literature
review 80 articles anterior repair
vagina has three layers-mucosa, muscularis, and
adventitia; there is no vaginal "fascia."
“Dissection during anterior colporrhaphy splits vaginal
muscularis, and repair involves plication of the muscularis
and adventitia (not vaginal "fascia")”
Vaginal Fibromuscular wall
“The
Posterior
•non-keratinized stratified
squamous epithelium
Bladder
Wall
fused with
•concentrically arranged
smooth muscle
▓
compartment2
Cadaveric
dissection of the RV “septum”
is no evidence of a distinct fascial layer between
the posterior vaginal wall and the anterior wall of the
rectum”
“It is the splitting of the adventitial layer from the
overlying vaginal wall that accounts for the “fascial layer”
seen surgically”
Fascial “capsule”
“There
•formed from condensation
of irregular loose areolar
endopelvic connective tissue
1Weber A, Walters M. Obstet Gynecol 1997;89(2):311-8
2Kleeman et.al. Paper #10 SGS 2005
True
vesicovaginal
space
▓
Potential graft
placement sites
Reiffenstuhl, et al, Vaginal Operations, 1994
Improper Mesh Placement
Cundiff: Obstet Gynecol, Volume 104(6).December 2004.1403-1421
Dissection Technique
Hydrodissection





Access to the correct anatomic spaces
 minimizes bleeding
 mobilizes/avoids hazards (ureters, bladder, blood vessels)
 allows anatomically correct graft placement
Potentially minimizes exposure risk



Literature review 80 articles anterior repair
“Dissection during anterior colporrhaphy splits vaginal muscularis, and repair
involves plication of the muscularis and adventitia (not vaginal "fascia")”
Posterior compartment1


Tuohey needle

Anterior Compartment1


Hydro-dissection
Arguably the most important aspect of transvaginal mesh
augmentation
Cadaveric dissection of the RV “septum”
“It is the splitting of the adventitial layer from the overlying vaginal wall that
accounts for the “fascial layer” seen surgically”
47
18g Epidural needle
5mm gradations for depth
Rounded (non-cutting) tip
Hydrodissection*
Hydrodissection Guidance





Set yourself up for success with manipulation of the vaginal wall
Place 2 allis clamps on the vaginal wall
Pinch back against the bladder to potentiate space
Use a 22 bevel or Touhey needle
Use at least > 60cc per dissected compartment





60cc marcaine w/ epi diluted with 60cc injectable saline
Hold sagitally and displace bladder
Little resistance should be encountered
No “wheal” in epithelium (too superficial)
Extend laterally using standard needle



Hydrodissection is critical (20-80cc)
Getting to the true Vesicovaginal/Rectovaginal
space is critical.
Tips exist for identifying this space


avoid blanching and wheal
space is path of least resistance
*Prolift consensus forums 2005
Anterior Hydrodissection
Full thickness
vaginal wall
True vesicovaginal
space
Fluid bubble
Pubocervical
fascia
Primary Responder: Dr.
Heather van Raalte
True vesico-vaginal
space
Paravesical fat
48
Do Synthetic Grafts Increase the
Success of Transvaginal Repair of
Pop?
+ Benefit
Do Synthetic Grafts Increase the
Success of Transvaginal Repair of
Pop?
+ Benefit
No Benefit
Safety of Transvaginal Mesh




No Benefit
So…Where are we now?
Serious adverse event rate is low
Serious mesh-specific adverse event rate is very
low
Adverse event rate is comparable to traditional
surgery
Mesh-specific adverse events are manageable


Study design for 522 trials near completion
Several companies will be participating

AUGS “registry” will allow for tracking options creating
opportunities for various sub populations and analysis

MSIG – has been formalized allowing high volume TVM experts to

Current marketplace
be part of process



June 4, 2012 J & J announces that the Gynecare division will
be no longer be selling Prolift, Prolift+M, Prosima and TVT
Secure in the US
Legal ramifications
Multi district suit
Recent AUGS Position Statement on Restriction of
Surgical Options for Pelvic Floor Disorders


“In some circumstances transvaginal mesh for
POP may be the most appropriate surgical
option”
A review of more current studies from 2011 and
2012 suggest that transvaginal mesh placed by
experienced mesh surgeons may have mesh
erosion rates comparable to abdominally placed
mesh
Pro: the contemporary use of transvaginal mesh in surgery for pelvic organ prolapse. Krlin RM et al. Curr
Opin Urol, 2012 22(4): p282-6
http://www.augs.org
49
Encourage Patients to Write to the FDA about
their Positive Experiences
Path forward




Develop effective robust communication tools for
patients to better understand how/why the benefits
outweigh the risks of TVM for their individual situation
(including brief hx of what has transpired)
Be balanced when discussing surgical options for mesh
delivery to pelvis i.e. endoscopic vs. vaginal approach
In your documentation, utilize recommended guidelines
on risk factors for recurrence that establish whether TVM
is appropriate
Recommit to enhancing your knowledge in material
science of synthetic construct and your surgical skill set in
performing TVM procedures
Summary




Summary
With changing demographics as well as the
higher expectations on the demand for effective
treatment for POP, Gyn surgeons will be facing
the challenge to meet patient expectations
Proper diagnosis of the nature of the support
defects comprising the pts POP is critical to
planning appropriate surgical options
Careful quantitative staging of POP is also key
to accurate pre- and post-operative assessment
Both obliterative and RPS can be appropriate
in properly selected and counseled patients




Conclusion
For many patients the era of reconstructive
pelvic surgery limited to the use of native
tissues is ending. We are facing a new era in
which material science and surgical
techniques will continue to bring
advancements in surgical treatments that will
potentially improve our patients experience
and long term functional outcomes. The
biggest challenge will be the decisions
that we face in when and how to
incorporate their use.
50
Native tissue repairs for POP leave room for
outcome improvement, especially durability
Material science innovation can offer
advances in long term successful outcomes
Traditional abdominal techniques using
mesh are morbid and difficult for patients
Minimally invasive vaginal or endoscopic
mesh implantation lowers morbidity which
can lead to an improved patient experience
Occult Incontinence: To treat or not?
Disclosure
I have no financial relationships to disclose.
Neena Agarwala, MD, MSc
Associate Clinical Professor
St. Luke’s Roosevelt Hospital Medical Center
Columbia University Affiliate
New York, NY
Objective
Occult Incontinence
Review the basic concept of occult incontinence
Definition: SUI that is not symptomatic but becomes apparent only during clinical or urodynamic testing (i.e. cough stress test after prolapse reduced)
Denovo SUI : SUI that is newly symptomatic, as when SUI develops after prolapse repair in a woman who was continent before surgery
Occult SUI
Patient perspective
• Diagnosed using pre‐operative prolapse
reduction testing in 31‐80% of continent women with symptomatic and/or advanced prolapse who are planning to have surgery
• When these women undergo prolapse repair without a concomitant continence procedure, the rate of post‐operative denovo SUI is 13‐
65%
• Prolapse is bothersome
• Incontinence is debilitating
51
Clues to detecting occult SUI
Diagnosis of Occult SUI
• Incontinence that improves or resolves as prolapse worsens
• The need to manually replace the prolapse
structures in the vagina to void
• Worsening or development of SUI with use of pessary
• Medical history
• Clinical or urodynamic testing with and without reduction of prolapsed organs
• Prolapse reduction can be done by fingers, cotton swab, speculum blade, ring forceps, or pessary. One is probably not superior to another, except that the pessary is the least diagnostic.
POP with no symptoms of SUI
Elevation of bladder neck relieves the kink
• Most experts consider women with positive testing for occult SUI to be similar to women who have SUI symptoms, and advise combined surgery for prolapse and SUI
• However, it is controversial what to do to the bladder neck in women with symptomatic prolapse but no SUI on pre‐operative testing with reduction, especially for POP surgery by the vaginal route
Risk of developing postoperative SUI in women undergoing surgery for POP (UpToDate 2011)
Risk of developing SUI in women undergoing surgery for POP +clinical sxs of SUI
Women undergoing surgery for POP
No incontinence surgery Incontinence Surgery
Borstad 2006 65/90 (72%) Colombo 1997 SUP 6/15 (40%)
Colombo 2000 19/33 (58%)* Colombo 1997 NS 6/21 (29%)
De Tayrac 2004 5/14 (36%) Colombo 2000 RPU 5/35 (14%)*
De Tayrac 2004 TVT 1/15 (6.7%)
Partoll 2006 TVT 2/37 (5%)*
Wille 2006 RPU 0/14 (0%)*
Total : 89/137 (65%)
Total : 20/137 (15%) * Denotes abdominal procedures No clinical sxs of SUI Clinical sxs of SUI
52
Risk of developing postoperative SUI in women undergoing surgery for POP
Risk of developing postoperative SUI in women undergoing surgery for POP
No clinical symptoms of SUI
‐ occult testing No Clinical sxs of SUI
+occult stress testing
No incontinence surgery Incontinence surgery
No incontinence Surgery Incontinence Surgery
Bergman 1998 0/43 (0%)
Chalkin 2000 0/10 (0%) Colombo 1990 4/62 (8%)
Kutke 2000 0/20 (0%) Liang 2004 0/30 (0%)
Reena 2007 0/25 (0%)
Visco 2008 41/109 (38%)*
Total : 45/289 ( mean 16%) Bump 1996 SUP 0/5 (0%)
Bump 1996 NS 0/4 (0%)
Colombo 1996 SUP 4/50 (8%)
Visco 2006 RPU 22/106 (22%)*
Wille 2006 RPU 0/14 (0%)*
Total : 26/179 ( 15%)
In the 2006 CARE trial, sacrocolpopexies
were done with and without Burch
De Tayrac 2004 1/6 (13%) Liang 2004 11/17 (65%)
Reener 2006 34/53 (80%)
Visco 2008 23/40 (50%)*
17 studies 1996‐2000
Total : 69/118 (59%)
Total: 76/502 (15%)
Burch sutures
• In women with POP having ASC who were continent before surgery, Burch decreased the rate of post‐operative SUI ( 32% for Burch vs 45% for no Burch)
• For women with occult SUI on pre‐testing, 37% had SUI after Burch and 60% had SUI after no Burch
• For women with no occult SUI on pre‐testing, 20% had SUI after Burch and 39% after no Burch
OPUS Trial
Controversy
• In this multicenter RCT, 337 women without SUI but having vaginal surgery for POP were randomized to TVT or sham surgery
• The rate of UI at 12 months was 27.6% in the TVT group and 43% in the sham group (P=0.002)
• 6.3 slings were placed to prevent 1 case of UI at 12 months • UTIs, bleeding complications (3.1%), and voiding disorders (3.7%) were all higher in the TVT group
• However, it is still controversial what to do to the bladder neck in women with symptomatic prolapse having vaginal surgery who have no SUI on pre‐operative testing with reduction
• Wei JT, et al. N Engl J Med 2012; 366:2358‐2367
53
Occult SUI ‐ Summary
Prolapse and no SUI: Using reduction stress test (RST) to decide whether a sling should be done • For a patient with occult SUI having abdominal sacral colpopexy, one may choose Burch if the case is open, and TVT or TOT if it is L/S or Robotic
• For prolapse cases with occult SUI done vaginally, best to choose a sling with the highest benefit and lowest risk. Patients are especially intolerant of urinary retention in this setting.
• Choose a TOT over a RP TVT in women with occult SUI because there are comparable cure rates for SUI, but less risk of urge and retention. ISD is rare in this poplulation.
• Cohort Study: 152 women had laparoscopic sacral colpopexy
and followed 4‐21 months
• Women with a (‐) RST had sacral colpopexy only; women with a (+) RST had sacral colpopexy + sling
• At follow up 18.6% of women in the (‐) RST group had a later sling for de novo SUI
• In the (+) RST group 7.3% had voiding difficulties requiring sling revisions
• Overall, 88% of patients did not need a second surgery
•
Park J, et al. Int Urogynecol J 2012; 23:857‐864
Our data
May be • For prolapse cases with no occult SUI on pre‐
op testing, one might do a small suburethral
plication to try to prevent early denovo SUI (unsupported by evidence) • Consider Mini‐slings
•
•
•
•
•
References
• Brubaker L, Cundiff GW, Fine P, et al. Abdominal sacrocolpopexy with Burch colposuspension to reduce urinary stress incontinence. N Engl J Med 2006; 354:1557‐66
• Wei JT, Nygaard I, Richter HE, et al. A midurethral sling to reduce incontinence after vaginal prolapse repair. N Engl J Med 2012, 366:2358‐
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• UpToDate
• Laparoscopic or Robotic Sacrocolpopexy with Tension‐Free Sling to Prevent and Treat Symptomatic or Occult Stress Urinary Incontinence L B Westermann, J Kissling, N Agarwala www.urotodayinternationaljournal.com Volume 5 ‐ April 2012
54
Use of mini‐sling for occult SUI patients No adverse events
Less than 5% denovo SUI
High patient satisfaction
Less OR time, less blood loss and less voiding dysfunction
Disclosure
Fistulae and Diverticulae

I have no financial relationships to
disclose.
Charles R. Rardin, MD
Associate Professor of OB/Gyn
Director, Fellowship in Female Pelvic Medicine and
Reconstructive Surgery
Alpert Medical School of Brown University
Director, Minimally Invasive and Robotic Surgical Services
Women &Infants Hospital
Providence, RI
[email protected]
Rectovaginal Fistula: Causes

Obstetric trauma produces 88% of RVF







50% of women with Crohn’s Disease will develop perianal
fistulas; 5-10% will develop RVFs
Much lower incidence with Ulcerative Colitis


cryptoglandular abscess, Bartholin’s, rectovaginal hematoma,
LGV, tuberculosis, Diverticulitis
Prior surgery
Cancer

Radiation – up to 6%








48% preoperative anal incontinence
This will be important in selecting treatment options
Patients with postoperative AI are unsatisfied despite
“success” in RVF repair
Tsang CBS, Surg Clinics N Am, 1997
Champagne BJ, Surg Clin N Am 90 (2010)
Venkatesh KS, Dis Colon Rectum 1989
Diagnostic Evaluation

Vaginal passage of stool, gas, mucopurulent
drainage
Dyspareunia, pelvic pain or vaginal infections
Evaluation of continence status

Infection



0.1% of vaginal deliveries in the western world
Sub-saharan Africa and Asia: 100,000 new cases annually
Inflammatory Bowel Disease


Presenting Symptoms
Fistulography
Examination of vagina, rectum and perineum
Vagina instilled with water (+/- soap) to evaluate
for air bubbles upon rectal instillation
Vaginal tampon with rectal instillation of dye
Vaginography (79-100% sensitive)
Fistulogram
Ultrasound
CT with oral contrast
MRI
Proctoscopy


55
water-soluble dye infused rectally (foley
catheter). Fill balloon with air to minimize
obscuring distal fistulae
alternative: Defecogram with barium/water
and thickener, and valsalva
Imaging Modalities
Modality
Predictive Value
Contrast Vaginography
79%
Contrast Proctography
35%
Endoanal Ultrasound
7-73%
Imaging – one rationale
Comments
Endoanal ultrasound with 48-73%
H2O2 tract instillation
MRI
Approaches
100%
CT
>60% (not
evaluated
recently)
Simple RVF, especially those with anal
incontinence – consider transanal
ultrasound
Complex RVF – consider MRI

Commonly part of OB trauma
evaluation; evaluates
concomitant sphincter injury

More accurate than digital,
ultrasound or surgical (?)
Some instances of mistaking
vascular structures as fistula
Champagne BJ, Surg Clin N Am 90 (2010
Tsang Classification


Treatment options

Daniels anatomic descriptions
Also considers etiologies



Classification of Rectovaginal Fistula
Simple
•Low or Mid-vaginal Location
•Size < 2.5 cm
•Trauma or Infection
Observation
Medical – Crohn’s only

Complex


•High Vaginal Location
•Size ≥ 2.5 cm
•IBD, radiation or cancer
•Previous failed repairs
Obstetric or trauma – some possibility (≤25%) of resolution
Cancer, IBD, radiation – little chance
cyclosporine, 6-MP, inflimixab
Disappointing results in RVF
Fibrin Sealant




Reported success of up to 74%*
Multiple applications may be required
Others’ experiences much less optimistic
Risk is minimal
Tsang CBS, Surg Clinics N Am, 1997
*Hjortrup A, Dis Colon Rectum 1991
Timing of Surgical Repair

Principles of Surgery
Surgical intervention – allow for tissue
healing


Historical recommendations of 2-6 months
after injury
 Most level III evidence now allows for earlier
repair if no evidence of active inflammation
 Medical control of proctitis or other
inflammatory concerns





optimize granulation, infection and edema
repair must interrupt continuity of the tract
interpose a layer of fresh, vascularized tissue
excise the tract, evert the ostial edges
2nd layer closure will reduce the tension on
the first layer
vaginal side (low pressure side) may be left
open to drain
DL Nichols, 2000
56
Surgical Treatment:
High fistula repair


Local Repairs: Layered Closure
Usually related to IBD or diverticulitis
potential clues
passage of liquid stool per vagina with solid
stool per rectum
 excoriation of vagina and vulva due to
digestive enzymes



Abdominal approach
Resection of bowel segment with diseased
tissue, primary anastomosis is most
successful
Endoanal Advancement Flap
Local Repairs: Perineoprocotomy
A 34-year old primipara whose delivery was
complicated by a third-degree perineal laceration,
subsequently underwent a layered-closure type
surgical repair of a rectovaginal fistula by another
surgeon in a different subspecialty. She is dissatisfied
with the outcome of the reparative procedure when she
presents to you for further evaluation. The most likely
cause of her dissatisfaction is:
A.
B.
C.
D.
Low- or Mid-Level Fistula
Local repair Techniques
Approach and Technique
Success Rate
Transvaginal
Layered Closure
84-100%
Fistula Inversion (Latzko)
73%
Transanal
Recurrence of the fistula
Vulvar asymmetry
Failure of the procedure to correct her anal
incontinence
Frustration with the obstetrical events leading up
to her perineal injury
Layered Closure
84-100%
Advancement Flap
78-100%
Transperineal
57
Perineoprocotomy with layered closure
88-100%
Sphincteroplasty
78-100%
Fistulotomy
Not recommended
(sphincter disruption,
high reoperation rate)
Outcomes of Repairs


Surgical Approach to Simple RVF
48% of women with obstetrical fistula also
reported incontinence prior to repair
65% of those with FI remained incontinent
after fistula repair
Anal Sphincter Defect
(Symptoms or Ultrasound)
Normal
100% after flap advancement
 48% after sphincter repair
Defect


1. Layered Closure
2. Advancement Flap
3. Fistula Inversion
Of women with successful repair of fistula


42% were unsatisfied
all of those remained incontinent
Tsang CBS, Surg Clinics N Am, 1997
Tsang CBS,. Dis Colon Rectum 1998
Temporary Diversion?



1. Transperineal
Sphincteroplasty
2. Perineoproctotomy with
layered closure
Urethral Diverticulae
Expert Opinion varies widely
Not usually required for primary repair of
midlevel or low fistula repair (simple)
Exceptions may include:
radiation injury
severe perineal infection
 Complex colorectal repairs
 Failed previous attempts


58
Disclosure
I have no financial relationships to disclose.
Refractory OAB‐
Interstim and Botox Treatment of Urinary Incontinence
Lawrence Lin MD
Thousand Oaks, CA
1st line of treatment for OAB Behavioral Therapy
2nd line of treatment:
Pharmacologic agents
Failed all medical management
I. Failed the antimuscarinics
1st line: Failed Behavior therapy
• Failed bladder retraining and timed voids
• Failed biofeedback
• Failed pelvic floor physical therapy ‐ Failed Vesicare, Enablex, Toviaz, Sanctura, Oxytrol, Ditropan etc.
II. Failed tricyclic antidepressants
‐ Failed imiprimine
III. Failed B3 adrenergic agonist ‐ Myrbetriq (Mirabegron)
3rd line of treatment for OAB
Bladder Botox
• FDA approved in Jan 2013
• 8 serotypes of Botox:
‐Only Botox “A” FDA approved
Specifically, onabotulinumtoxin A
3rd
line of treatment: There are 2 options
(a) PTNS (Percutaneous Tibial Nerve Stimulator)
(b) Bladder Botox A
• Causes the bladder muscles to relax to increase the bladder capacity, and decreases UI. • Affects skeletal muscles, yet the bladder is a smooth muscle
• Botox is manufactured by Allergan
Inc.
59
Mechanism of action: Botox A
MECHANISM OF ACTION OF BOTOX A
•BOTOX® protein molecule passes through the cell membrane of the motor nerve via endocytosis
• Light chain of Botox A binds to the SNAP‐25 receptors on the nerve terminals and cleaves the SNAP 25 receptors. • Thereby, the Acetylcholine vesicle is unable to bind to the nerve terminals and unable to release the ACH at the neuromuscular junction, thereby preventing muscle contractions. •The light chain of the BOTOX protein molecule cleaves apart a protein (called SNAP25) that enables vesicles which store the neurotransmitter acetylcholine to attach to the cell membrane.
• Cleaving SNAP25 prevents these vesicles from fusing with the membrane and prevents the release of acetylcholine into the neuromuscular • Thus, nerve impulses that control muscle contractions are blocked decreasing muscle activity. Where to inject Botox A?
Indications: Botox A
• Avoid the trigone area
• Intradetrusor injections
Two FDA indications
1. Refractory OAB.
2. Detrusor overactivity associated with a neurological condition (eg spinal cord injury, MS)
– Approx 15‐20 injections
– Total of 10 ml of Botox (100 units)
– 5 injections per row x 3 rows
Clinical trials—Botox A
Contraindications for Botox A
• Two clinical trials of 1,105 patients with symptoms of overactive bladder. Patients were randomly assigned to receive injections of 100 units of Botox (20 injections of 5 units each) or placebo.
• Incomplete bladder emptying
• No UTI prior to treatment • History of recurrent UTI (2 or more UTI in 6 months)
• History of hypersensitivity to any botox
preparation
• History of pre‐existing Neuromuscular Disorders (eg Myasthenia Gravis) have inc risk of severe dysphagia and respiratory compromise
• Results after 12 weeks
– Botox pts experienced urinary incontinence an average of 1.6 to 1.9 times less per day than patients treated with placebo. – Botox‐treated patients also needed to urinate on average 1.0 to 1.7 times less per day and expelled an average of about 30 milliliters more urine than those treated with placebo
60
Adverse reactions: Botox A
Safe and effective dose: Botox A
• Doses: 100, 150, 200 units
• For OAB: ‐ the starting dose should be 100 units (in 10 ml of preservative free 0.9 NS)
‐ Administer 20 injections of 0.5 ml
• For NDO (Neurogenic Detrusor Overactivity)
‐ Starting dose is 200 units (30 ml) as 30 injections of 1 ml
Common side effects include:
• UTI (18%)
• Dysuria (9%)
• Increased PVR in up to 72%
• Incomplete emptying of the bladder (urinary retention) in 6‐20%
‐ Risk of intermittent self catheterization until the urinary retention resolves. Relative contraindication if pt is unwilling to perform self‐cath
Recommendations:
Repeat dosing for Botox A
Pre‐op instructions: Botox A • Treatment with Botox can be repeated when the benefits from the previous treatment have decreased, but there should be at least 12 weeks between treatments.
• Pre‐treat with lidocaine instillation 20 minutes prior to bladder injections
• Pt must be willing to perform CIC (clean intermittent cath) if required
• Max cumulative dose should not exceed 360 units in a 3 month interval (eg Botox used on face and other areas)
3rd line of treatment for OAB
PTNS
Postop instructions: Botox A
• Allergan’s antibiotic recommendation are:
Percutaneous Tibial Nerve Stimulator
‐ 1‐3 days of pre‐op antibiotics
‐ 1‐3 days of post‐op antibiotics • Immediately post injection, bladder should be drained and then observed in office for 30 min afterwards
• Assess PVR in 1‐2 weeks after injection. Risk of incomplete bladder emptying is highest after 1 week
• During first 12 weeks post injection, pt will contact your office if difficulties in voiding. • Indications: reducing OAB symptoms in the short and medium term OAB.
61
Risks for PTNS:
Overall, minimal risk:
• Bleeding or discomfort at the needle site (4%)
• ankle bruising and tingling in the leg
Contraindications:
• Pacemaker or defibrillator
Mechanism of action: PTNS
• Mechanism of action of PTNS: unclear. But thought to be mediated by retrograde stimulation of the sacral nerve plexus (neuromodulation).
• The posterior tibial nerve contains mixed sensory motor nerve fibers. Impulses travel along the tibial nerve to the sacral nerves.
• Tibial nerve has input S2,3,& 4 roots
Procedure PTNS:
•Fine needle is inserted percutaneously just above the ankle, next to the tibial
nerve
Duration of treatment: PTNS
• Initial treatment: 12 outpatient sessions Q weekly, each lasting 30 minutes each,
• Further sessions are generally needed for longer‐term relief
• A surface electrode is placed on the foot. The needle and electrode are connected to a
low‐voltage stimulator. • Stimulation of the posterior tibial nerve produces a typical motor (plantar flexion or fanning of the toes) and sensory (tingling in the ankle, foot or toes) response. Maintenance therapy for PTNS
Clinical Study #1: PTNS
• Tailored to each pt’s response
• Typically once a month
• A randomized controlled trial (RCT) of 220 patients treated by – PTNS 55% (60/110) moderate or marked improvement
– Sham 21% (23/110) improvement of bladder symptoms of patients respectively at 13‐week follow‐up (p < 0.001)
Peters K et al. J Urol 2010.
62
Clinical Study # 2: PTNS
Clinical Study # 3: PTNS
• An RCT of 100 patients treated by:
‐ PTNS reported that 80% (35/44) improved or cured ‐ Medication: 55% (23/42) of patients considered themselves to be cured or improved after 12 weeks of therapy (p = 0.01)
• To compare the clinical efficacy of PTNS to Toerodine –LA for urinary frequency
• 12 week treatment
• N=100
• 1:1 randomization
RESULTS: Similar efficacy PTNS = Detrol LA
Peter KM et al. J Urol. 2009 Sep 182 (3): 1055‐61
4th line of treatment OAB:
Sacral Neuromodulation (Interstim)
Final Conclusion PTNS
• Interstim is stimulation of the sacral nerves to reduce the reflexes that influence the bladder, sphincter, and pelvic floor
• PTNS is significantly better when compared to placebo.
• PTNS is similar in efficacy to Detrol LA
• Interstim utilizes mild electrical pulses to improve normal voiding function
4th line of treatment OAB:
Sacral Neuromodulation (Interstim)
Mechanism of action: Interstim
MOA:
Direct stimulation of the S3 sacral nerve
Objective: Place the tined lead into S3 foramen
Two stages: • Stage 1: Trial phase with an external IPG (implantable pulse generator) and a temporary or permanent lead
• Stage 2: Permanent lead and IPG placed if trial is successful
63
4th line of treatment OAB:
Sacral Neuromodulation (Interstim)
Interstim: Placement of lead at S3 foramen
2 approaches
I. PNE (Peripheral Nerve Evaluation) approach. Stage I: Placement of a “temporary” lead in the office setting and if successful, then proceed with Stage 2– placement of “permanent” lead and IPG in the OR.
II. Staged Approach. Stage I: Placement of “permanent” lead placement in the OR. Stage 2: If successful, return to OR to place IPG
Interstim: S3 foramen
Stage I Interstim
Placement of an external IPG
64
Stage I  Stage II Interstim
If Stage I is successful
(with x>50%) reduction in
symptoms, then proceed
with implantation of the
IPG
65
CULTURAL AND LINGUISTIC COMPETENCY
Governor Arnold Schwarzenegger signed into law AB 1195 (eff. 7/1/06) requiring local CME providers, such as
the AAGL, to assist in enhancing the cultural and linguistic competency of California’s physicians
(researchers and doctors without patient contact are exempt). This mandate follows the federal Civil Rights
Act of 1964, Executive Order 13166 (2000) and the Dymally-Alatorre Bilingual Services Act (1973), all of which
recognize, as confirmed by the US Census Bureau, that substantial numbers of patients possess limited English
proficiency (LEP).
US Population
Language Spoken at Home
California
Language Spoken at Home
Spanish
English
Spanish
Indo-Euro
Asian
Other
Indo-Euro
English
Asian
Other
19.7% of the US Population speaks a
language other than English at home
In California, this number is 42.5%
California Business & Professions Code §2190.1(c)(3) requires a review and explanation of the laws
identified above so as to fulfill AAGL’s obligations pursuant to California law. Additional guidance is provided
by the Institute for Medical Quality at http://www.imq.org
Title VI of the Civil Rights Act of 1964 prohibits recipients of federal financial assistance from
discriminating against or otherwise excluding individuals on the basis of race, color, or national origin in any of
their activities. In 1974, the US Supreme Court recognized LEP individuals as potential victims of national
origin discrimination. In all situations, federal agencies are required to assess the number or proportion of LEP
individuals in the eligible service population, the frequency with which they come into contact with the
program, the importance of the services, and the resources available to the recipient, including the mix of oral
and written language services. Additional details may be found in the Department of Justice Policy Guidance
Document: Enforcement of Title VI of the Civil Rights Act of 1964 http://www.usdoj.gov/crt/cor/pubs.htm.
Executive Order 13166,”Improving Access to Services for Persons with Limited English
Proficiency”, signed by the President on August 11, 2000 http://www.usdoj.gov/crt/cor/13166.htm was the
genesis of the Guidance Document mentioned above. The Executive Order requires all federal agencies,
including those which provide federal financial assistance, to examine the services they provide, identify any
need for services to LEP individuals, and develop and implement a system to provide those services so LEP
persons can have meaningful access.
Dymally-Alatorre Bilingual Services Act (California Government Code §7290 et seq.) requires every
California state agency which either provides information to, or has contact with, the public to provide bilingual
interpreters as well as translated materials explaining those services whenever the local agency serves LEP
members of a group whose numbers exceed 5% of the general population.
~
If you add staff to assist with LEP patients, confirm their translation skills, not just their language skills.
A 2007 Northern California study from Sutter Health confirmed that being bilingual does not guarantee
competence as a medical interpreter. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538.
66