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Constellation of physical finding and symptoms
Bladder Function
UI & VD
Sexual
Function
POP
Bowel Function
FI & DD
R. Keith Huffaker, M.D.
ETSU Center for Pelvic Surgery and Urogynecology
East Tennessee State University
Quillen College of Medicine
Prevalence of POP or PFD in Noninstitutionalized
U.S. Pop
Pelvic floor disorders affect a
substantial proportion of women
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Pelvic Floor Disorders
Prevalence of POP or PFD in Noninstitutionalized U.S. Pop, Impact of Age
PFD
N = 1,961, > 20 y/o, sample
’05-06 NHANES
UI
FI
POP
50
N =1,961
20
40
15
30
%
%
20
10
10
5
0
0
20-39
PFD
UI
FI
40-59
60-79
>80
POP
Age, years
Nygaard et.al. Pelvic Floor Disorders Network.
JAMA. 2008 Sep 17;300(11):1311-6
Nygaard et.al. Pelvic Floor Disorders Network. JAMA. 2008 Sep 17;300(11):1311-6
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Surgery for POP and UI
Prevalence of > 1 PFD in Noninstitutionalized U.S. Pop., Impact of Weight
12
Cumulativ
ve Incidence (%)
30
N = 1,961, > 20 y/o, sample
’05-06 NHANES
25
20
% 15
10
10
5
0
8
6
4
2
0
20-29
Normal
Overweight
30-39
Obese
40-49
50-59
60-69
70-79
Age Range (years)
Weight
Olson et al, Obstet Gynecol 1997;89:501
Nygaard et.al. Pelvic Floor Disorders Network. JAMA. 2008 Sep 17;300(11):1311-6
PFDs Significantly Impact QoL
Impact of POP/PFDs
Qol Indicator
Impact
y >200,00 surgeries performed for POP or UI each year in the U.S.
y Projected 45% increase in next 30 years
•Physical
Limited activities
•Social
Isolation
•Sexual
Avoidance
y Cost exceeds 1 billion dollars/y
•Psychological
Depression, Loss
of self esteem
y Untreated symptomatic POP/PFD have a significant negative impact on QoL
•Occupational
Decreased
nonsurgical
treatments
productivity
Majority of surgical and
of
demonstrate
significant
•Domestic PFD’sPersonal
hygiene
improvement in QoL
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Urinary Incontinence Prevalence Rates by Age and Gender
Urinary Incontinence
18%
16%
y A condition that affects more than 10 million Americans.
14%
Prevalence
y Involuntary leakage
y Less than 50% of incontinent women seek care—
under‐reported.
y Direct financial costs of over $15 billion.
Male
Female
12%
10%
8%
6%
4%
y Only a fraction spent for diagnosis and treatment.
2%
0%
5-14
15-24 25-34 35-44 45-54 55-64 65-74 75-84
>85
Total
Age (Years)
Thomas TM, et al. Br Med J. 1980;281(6250):1243-1245.
hh1
Urinary Incontinence Is More Prevalent than Other Chronic Conditions in Women
Prevalence in Women
40%
35
25
20
20%
10%
0%
Predispose
Gender
Race
Neurologic
Muscular
Anatomic
Collagen
Family
UI not life-threatening, but QoL issue
30%
Risk Factors for Urinary Incontinence
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Incontinence1
Hypertension2
1. Hampel C, et al. Urology. 1997;50(suppl 6A):4-14.
2. American Heart Association. Electronic Citation; 2001.
3. American Family Physician. Electronic Citation; 2001.
4. NIDDK. Electronic Citation; 2001.
Depression3
Diabetes4
Incite
Childbirth
Hysterectomy
Vaginal surgery
Radical pelvic surgery
Radiation
Injury
Abnormal
Intervene
Behavioral
Pharmacological
Devices
Surgical
Stress
Function
Normal
Promote
Obesity
Lung disease
Smoking
Menopause
Constipation
Recreation
Occupation
Medications
M di ti
Infection
Decompensate
Aging
Dementia
Debility
Disease
Environment
Medications
Bump RC, Norton PA. Obstet Gynecol Clin North Am. 1998;25(4):723-746.
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Slide 12
hh1
black outs with video of woman; gender, race
hhubbard, 6/6/2002
Office Evaluation of
Urinary Incontinence (History)
Urologic Symptoms
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Stress incontinence
Urgency
Urge incontinence
Frequency
Nocturia
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Enuresis
Dysuria
Difficulty voiding
Post‐void fullness
Post‐void dribbling
Hematuria
Stress Incontinence
OverActiveBladder
Consultation for Evaluation of Lower Urinary Tract Dysfunction
Frequency (7/day)
Nocturia
Nocturnal enuresis
y Persistent UTI following tx
y Small bladder capacity
y Abnormal neurologic function
y Fistula
Coital incontinence
y Signs of voiding dysfunction or retention
y Absent sensation
y Large bladder capacity
y Elevated post‐void residual
y Failure of response to treatment for incontinence
Severity
Infection
Obstruction
Detrusor dysfunction
y Urethral diverticula
Walters MD et al J Am Board Fam Pract 1992;5:289
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Other Causes of Accidental Urine Loss
Urinary Incontinence Symptoms/Dx Symptom/Dx
Symptoms:
Description
y Overflow
Leakage with physical exertion or
on sneezing or coughing
y Functional
y Ectopic ureter
Ectopic ureter*
Continuous & Insensitive
Urge
Leakage with a strong and urgent desire to void
y Fistula*
high volume UI
Mixed
Combination of stress and urge
y Urethral diverticulum*
Post void dribbling &
dyspareunia
Stress
Frequency & Urge Inc
*less common.
Voiding Diary Verses Fluid Intake / Output Diary
Q‐tip Test
Hypermobile > 30 degrees
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Cystometry
•Pressure‐volume relationship of the bladder to filling
•Main diagnostic value to assess stress incontinence and detrusor overactivity
•Improvement of sensitivity p
y
with:
•Maximum capacity
•Patient standing
•Detrusor‐provoking maneuvers
Terminology
Technique
Fill with
ith normall saline
li
Detrusor overactivity
Bladder pressure (Pves) monitored
Standing patient valsalvas
Pves at which leakage occurs = aLPP
Variables: catheter size, volume, patient position,
vaginal prolapse, radiographic vs. visual
• “urodynamic” definition
Urge incontinence
• sensory
• motor
• hyperreflexia
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Additional tests
Additional tests
Uroflow
• Depicts urinary flow rate and
pattern
Pressure flow study
• Identifies bladder outlet
obstruction
• Pdet = Pabd - Pves
• No diagnostic cut off to identify
obstruction in women
(?Pdet < 40 cm water, max flow rate >15)
Sphincter EMG
• Evaluates sphincter control
and coordination (DSD)
• Does not identify neuropathy
Video urodynamics
•
•
•
•
DSD
Vesicoureteral reflux
Outlet obstruction
Associated pathology
Pelvic Floor Muscle Training Treatment Options for SUI y Nonsurgical
y Weight reduction if obese
y Pelvic Floor Muscle Training*
y Incontinence Pessary
I
i
P
y SRI (Duloxetine)?
Electrical
Stimulation
Home
H
Biofeedback
Vaginal Weights
y Surgical* y Minimally invasive outpatient procedures
y
y
TVT/TOT
Urethral bulking
*most accepted Rx modalities
1. Experienced Pelvic Floor
Physical Therapist
2. Motivated Patient
Pelvometer
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SUI Pessaries
FemsoftTM Urethral Inserts
Management of OAB
1ST TIER
BEHAVIORAL Rx
Fluid & caffeine modulation
Bladder retraining/PFMT
1. MEDICAL MANAGEMENT =
2. Anticholinergics*
1. only 10-15% continue >1yr
2. nongenerics expensive
3. similar efficacies & side-effects
2nd TIER
INTRAVESICAL BOTOX
3rd TIER
AUGMENTATION CYSTOPLASTY
NEUROMODULATION
1. Sacral N.
2. Peripheral N.
URINARY CONDUIT OR CONTINENT DIVERSION
*significant placebo effect in trials
Medical Management of OAB
What are the anti‐cholinergic side‐
effects?
Improve tolerability :
y Anticholinergics/Antimuscarinics
y Dry mouth* y Constipation*
y Results:
y 70 ‐ 90% improvement in symptoms
y 20 ‐ 40% completely continent
y Blurred vision
y Anhidrosis
1. Dry Mouth = “sign of
effectiveness” & use of gum or
hard candy for Rx
p
2. MOM or Miralax for constipation
y Elderly – confusion, sleep disturbance, dizziness & increase risk of fall
y Flexible dosing regimens and side‐effects
*Most common
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Contraindications for Anticholinergic Rx of OAB
Long Term Use of Anticholinergics given for Urge Incontinence
y Uncontrolled narrow angle glaucoma
y ~50% patients don’t refill original script
y Significant PVR (unless supplemented with CISC)
y ~10 – 15% try different preparation
y Gastric retention
y Only 10 – 15% persist with Rx for 1 yr
y Adherence rates in practice much lower than in studies
y Perception of lack of efficacy, side‐effects, polypharmacy, & costs
y Importance of patient counseling and coordinated management plan
y Hypersensitiviy to any of formulations
y Caution in patients with renal or hepatic impairment
Eur J Clin Pharmacol. 2009 Mar;65(3):309-14.
J. Manag Care Pharm. 2008 April 14(3):309-11.
BJU Int. 2008 Sep;102(7):774-9.
Botox Mechanism of Action
Intravesical Botox Injection
y Indicated for Refactory OAB (unresponsive to anticholinergics and behavioral RX) y Both Neurogenic and idiopathic OAB respond to BTxA (J Urol. 2005 Sep;174(3):984‐9)
y Efficacy lasts for ~ 6 ‐12 mths Efficacy lasts for 6 12 mths (BJU Int. 2005 Oct;96(6):848‐52)
(BJU I t O t 6(6) 8 8 )
y Improves QoL, effect sustained after repeat injections (over 5 yrs), need for CISC ~47% (J Urol. 2009 Apr;181(4):1773‐8.)
y Not covered by Medicare and many private insurers
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Sacral Neuromodulation
Sacral Neuromodulation
y ~65‐90% maintain efficacy over 3‐5 yrs
y ~1/3 require repeat procedure (lead migration, pain, g
p
technical difficulties)
y Expensive
y Intractable OAB, failed nonsurgical Rx
y ~50% test pts demonstrate >50% improvement in symptoms by diary
y FDA approval 1997 (InterStimR, Medtronic)
y Lead & stimulator $10K
y Hosp/Surg fees $10‐20K
Urology. 2006 Mar;67(3):550-3. J
Urol. 2000 Apr;163(4):1219-22. Eur
Urol. 2000 Feb;37(2):161-71.
Peripheral Nerve Stimulation
y # different sites evaluated y Posterior Tibial Nerve Stimulation yNeedle and percutaneous methods
y30 min. weekly sessions
y~2/3 patients have significant improvement
y Not covered by Medicare and most private insurers
Summary
y UI negatively affects QoL and may lead to isolation and reduced productivity
y Effective Rx exist for Rx of UI
y Non‐surgical management is the mainstay of Rx for OAB/Urge Incontinence
y Intravesical Botox and neuromodulation are options for OAB failing anticholinergic Rx y Surgical Rx mainstay for significant SUI
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“Agnes…Your uterus is showing again”
Risk Factors for Symptomatic POP
y Increasing parity
y Vaginal delivery > c‐section
y
Protective effect of c‐section diminishes with increasing parity and ageing
y Forceps delivery >SVD
y Increasing weight
y Increasing strenuous work or activities
y Chronic straining with constipation
y Genetic factors
y Increased transverse diameter of pelvis
y Family Hx POP
y Personal Hx hernias or stretch marks
y Vaginal deliveries
Signs and Symptoms
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Pressure (fullness, heaviness)
Protrusion (“falling out”)
Urinary retention
Overflow incontinence
Constipation
V i l bl di ( l
Vaginal bleeding (ulceration)
ti )
y Vaginal Bulge and pressure/heaviness
y “feels like insides are going to fall out”
y Rarely associated with pain
y Symptoms increase throughout day & resolve with lying down
y Most reliable predictor of POP
y Minimal symptoms until “bulge” near or past the hymen
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Symptoms of POP
Symptoms of POP
y Poor correlation with anterior compartment prolapse and UI
y Stronger correlation with progressive AC POP and obstructive voiding
y c/o urinary hesitancy, increased throughout day
c/o urinary hesitancy increased throughout day
y Increased PVR and recurrent UTI
y Weak association between progressive posterior compartment prolapse & defecatory dysfunction
y Patients may admit to vaginal or peri‐rectal splinting
y Roughly 50 –
R
hl 70% improvement with surgical repair
% i
t ith i l i
y Weak association between PC prolapse and FI
y Most commonly in association with anal sphincter disruption or dysfunction
Pelvic Organ Prolapse
Physical Examination
y Anatomic support in female y Vaginal tissue
y Vaginitis
y Vaginal atrophy
y Scarring
y Neurologic examination, reflexes
y Levator muscle atrophy and tone
y Consider distended bladder, fecal impaction
y Thorough history and physical
Ancillary Physical
y Standing rectovaginal exam
y Stress urinary incontinence present prior to t i t prolapse/vault descent? Î
urodynamic studies
y Perineal descent
y Fecal incontinence? Î
endoanal ultrasound
y Determine location of y Examine in lithotomy and standing position
yQ
Q‐tip test
p
y Rectal prolapse
site‐specific defects?
y Evaluate for all defects
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Levator Ani Muscles
y Neuromuscular injury allows widening of the genital hiatus and chronic direct stress to the CT attachments
y Pts with POP 7x more likely to have major LA defects on MRI than controls
y PFM contractile force less in POP cases
Comparison of ordinal grading systems for prolapse, 1963-98
Obstet Gynecol. 2007 Feb;109(2 Pt 1):295-302.
Computer Enhanced
MRI image 23y/o Go
3D
Fibromuscular CT Attachments: DeLancey’s Levels of Support
Level I - Suspension
Level II - Attachment
Level III - Fusion
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Management Options for POP
Surgical Management of POP
y
y
1.
Minimally or asymptomatic – expectant
Natural Hx not well defined
y
y
•
Symptomatic y
y
1.
2.
3.
Keys to successful correction and durability:
Recognition of the CT defects leading to POP
Pessary or surgery
Surgery :
Reconstructive or obliterative
Vaginal, abdominal (open, laparoscopic, robotic)
Native tissue or augmentation
•
Surgeon experience
2.
•
•
3.
Repair the defects or,
Perform a compensatory procedure Repetition
Versatility Most recurrences occur in the AC – failure to recognize & repair the transverse/apical defect
.
Recurrent POP
y Historical risk of recurrent symptomatic POP requiring repeat surgery ~30%
y Recurrence risk following surgical repair of AC POP ranges from ~5 – 60%
y Recognition of the importance of apical loss of support increasing y NHDS Data,1979 – 1997.
y rate of repairs for cystocele and rectocele ~constant 120 ‐
140,000/y y rate of apical repairs increased by ~15 fold (1,400 to 22,000/year) y Recurrent POP (> Stage II) in 58% ‐ 1 yr FU
y 71% ant. & 45% post. colporrhaphy y only 4% with concurrent apical repair Boyles, Am J Obstet Gynecol 1999
y Native tissue repairs with attention given to apical POP show recurrent POP < 15% at 4 – 5 y FU
Shull, Am J Obstet Gynecol 2000
Silva, Obstet Gynecol 2006
Boyles et.al. Am J Obstet Gynecol 2003
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Mesh Kits
Better than repairs with native tissue?
$$
Recurrent or
persistent POP
Morbidity unique to mesh
use or kits
AMS ElevateTM
FDA 510 K Approval
Process
ACOG
PRACTICE
BULLETIN
CLINICAL MANAGEMENT GUIDELINES
FOR
OBSTETRICIAN-GYNECOLOGISTS
NUMBER 85, AUGUST 2007
Pelvic Organ Prolapse
“Given the limited data and frequent changes in the marketed
products…., patients should consent to surgery with an
understanding of the postoperative risks and complications
and lack of long-term outcomes data. .”
FDA Public Health Notification: Serious Complications
Associated with Transvaginal Placement of Surgical Mesh in
Repair of Pelvic Organ Prolapse and Stress Urinary
Incontinence (Issued: Oct 20, 2008)
National Health Service – National Institute for
Health and Clinical Excellence, June 2008.
•>1,000 reports from nine surgical mesh manufacturers of complications
•Most frequent = erosions , infection, pain, recurrent POP, and/or incontinence leading
to significant decrease in patient QoL
•Recommendations to physicians included – “inform patients mesh permanent,
complications may require subsequent surgery which may not correct the
complication”
•Encouraged reporting of adverse advents
French Health Authority's Report Nov 2006 – “transvaginal mesh
should be limited to clinical research”
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Conclusion
What factors influence your choice of Surgical Techniques for Rx POP?
y Patient age, physical activities and co‐morbid medical conditions
y Previous surgery, including failed POP Rx
y Concurrent AC & PC defects, need for hysterectomy or Rx SUI
Concurrent AC & PC defects need for hysterectomy or Rx SUI
y Patients desires & expectations
y Medical literature/research (EBM)
y Surgeons training & experience
y PFDs are relatively common and increase with ageing
y POP may or may not be associated with alterations in bowel, bladder, or sexual function
y Surgical correction of POP may enhance, maintain, or worsen enhance maintain or orsen bowel, bladder, or sexual function
y Management of PFDs must be individualized to the patients complaints, findings, & expectations
Female Pelvic Medicine and Reconstructive Surgery
y Urinary incontinence
y Incomplete bladder emptying
y Pelvic organ prolapse
y Fecal incontinence
y Vesicovaginal fistulae
y Rectovaginal fistulae
y Rectal prolapse
y Mesh complications
y Urinary tract infections
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