1. Assessment and Management of Female
Stress Urinary Incontinence
Saturday, May 17, 2008
6:00- 8:00 p.m.
COURSE 11 EC
FACULTY
Victor W. Nitti, M.D.
Course Director
Harriette M. Scarpero, M.D.
American Urological Association
Education and Research Inc.
2008 Annual Meeting, Orlando, FL
May 17-22, 2008
Sponsored by: The American Urological Association Education and Research, Inc.

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3. 2008 AUA Annual Meeting
11 EC Assessment and Management of Female Stress Urinary Incontinence
5/17/2008 6:00 - 8:00 p.m.
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Victor W. Nitti, M.D.
Course Director
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7. Assessment and Management of
Female Stress Urinary Incontinence:
State of the Art
Evaluation of Stress Incontinence:
Victor W. Nitti, MD What’s Essential and What is
Department of Urology
New York University School of Medicine
Helpful?
Victor W. Nitti
Harriette M. Scarpero, MD
Department of Urology
Vanderbilt University School of Medicine
AUA Female Stress Urinary Incontinence
SUI: What Drives Treatment Clinical Guidelines - Standard
• Nature, duration and severity of UI
• Preoperative evaluation of women with symptom of
• Effect of quality of life SUI should comprise the 4 major components of:
• Risks and transient causes – History (impact on Q of L)
• Prior therapy? – Physical exam (objective demonstration of SUI)
– Urinalysis
• Concomitant diseases – Other appropriate diagnostic studies designed to assess
– e.g. neurological disease, radical pelvic surgery symptom causes
• Urethral hypermobility, ISD, detrusor dysfunction, frequency and
• Comorbidities severity of incontinence episodes, patient expectations from
treatment
• Willingness to assume risk
Leach et al: J Urol 1997;158:875
AUA Female Stress Urinary Incontinence AUA Stress Urinary Incontinence
Clinical Guidelines - Standard Guidelines: Update 2008
• Patients should be informed of the available surgical • Purpose/Objectives: To establish a guideline for the
alternatives treatment of stress urinary incontinence in two types
– Estimated risks and benefits of each procedure of index patients:
– Choice of treatment made by patient and surgeon taking
into consideration patient preferences and experience and – The otherwise healthy woman who has decided to seek
judgment of the surgeon surgical therapy for stress urinary incontinence ( only
– Patients should be informed of complications and how they index patient used in first guidelines published in 1997)
would be treated
– The otherwise healthy woman, who has decided to seek
surgical therapy for stress urinary incontinence, and who
also has concomitant pelvic organ prolapse
Leach et al: J Urol 1997;158:875 Courtesy of Rodney Appell

8. Criteria
Procedures Considered
• Inclusion Criteria
– Surgical therapy for adult female stress urinary • Slings
incontinence. – Multiple types
– Minimum follow up of 12 months. • Suspensions
– Treatment available in the United States.
– Burch
– English Literature only.
– Laparoscopic
• Exclusion Criteria – Open Retropubic
– Surgical therapy that is deemed not current. • Bulking agents
– Male & peds pts; prolapse only patients – Collagen
• Artificial urinary sphincter
Sling Procedures Considered Methods
– Autologous fascia with bone anchors
– Autologous fascia without bone anchors
– Autologous vaginal wall slings w/without bone anchors
8000
– Autologous vaginal wall slings with bone anchors
7000
– Cadaveric with bone anchors
6000
– Cadaveric without bone anchors
5000
– Cooper's ligament sling (all sling materials)
4000
– Homologous tissue (dermis) with bone anchors
3000
7,111
– Homologous tissue (dermis) without bone anchors 2000
– Synthetic at bladder neck with bone anchors 1000
437 155
1,302 865
– Synthetic at bladder neck without bone anchors 0
– Synthetic at midurethra
Literature search results Chosen for Extraction
– Xenograft with bone anchors
Articles accepted Complications data only
– Xenograft without bone anchors Articles rejected
Recommendations Observations
• > 48 MONTHS: • Slings at the bladder neck have a higher rate of
– Inadequate data to make statement; for example, we know retention > 4 weeks post op or requiring surgery than
that > 1 million MUS done, but literature has data on only slings at mid-urethra or suspensions
80 patients
• De Novo Urge Post op
• 24 - 48 MONTHS: – Burch & MUS – Similar (confidence intervals overlap)
– Reaffirms data from 1997 Guidelines that Burch = Sling
• !RCT (Ward, Hilton)
• Unspecified urgency (urgency alone or with urge
• 697 Burches vs 715 slings
incontinence)
– Data does not allow us to distinguish between procedures

9. Observations Recommendations
• Mixed Incontinence
– A small # of studies suggest that surgical repair of • Prospective randomized controlled trials
the SUI component cures the urge component in
approx 70% of cases
• Consistency of diagnostic criteria
• Secondary procedures
– Retreatment rates are not accurate • Standardized outcome measures
• Many authors left this out
• Denominators not realistic or known
• Incidence of complications/type of secondary procedure not clear • Follow up > 12 months
– Prolapse rates following SUI procedure – too variable to
evaluate
Evaluation Urodynamics in SUI
• Once the desire for treatment beyond • Value of urethral resistance testing
conservative therapy is established what – ALPP, MUCP
factors may be important in determining
treatment and predicting outcome: • Value of cystometry
– Urethral mobility
– 30-50% of women presenting for treatment of SUI
• Physical exam (visual)
have mixed symptoms
• Q-tip test
• Radiographic determination – MUI patients tend to have more severe incontinence
– Urodynamics
– Voiding diary, pad testing • Value of evaluating voiding phase
SISTEr Trial; UDS in the SISTEr Trial
Urinary Incontinence Treatment Network (UITN)
• 2-fold greater odds for overall success for women with
• Randomized trial comparing the efficacy of Burch vs. urodynamic SUI vs. those without
PV in 655 selected women with pure or predominate – No USUI was about 10%
SUI for at least 3 months (9 sites through NIH/NIDDK) – After controlling for predictors of success in the
multivariable model this was nearly statistically significant
– < 12 micturitions/day
– No difference in stress specific cures
– Positive standardized stress test (volume < 300 ml)
– MCC > 200 ml • VLPP did not affect overall or stress specific outcomes
– PVR < 150 ml (unless POP grade II-IV)
• Presence of DO did not affect overall or stress specific
– Unobstructed voiding outcomes
• Qmax > 12 mL/s,
• PVR <150 mL • “Impact of UDS on surgical outcomes needs further
• pdetQmax < 50 cm H2O investigation”
Albo, et al NEJM 2007;356:2143-55
UITN Urology 2005;66:2113-2117 Nager, et al J Urol 2008;179:1470-1474

10. UDS for Patients with UDS Predicting Outcome For Surgery
Mixed Incontinence For MUI
• Several reports show that for patients with mixed Although there is lack of controlled studies available
symptoms and no DO on CMG cure for stress and data suggests that:
urge incontinence is high (72-87% cure)
– PV sling / Burch 1. Patients with MUI and no DO have better outcomes than
• Osman BJU International 2003; 92:964 those with DO with respect overall continence and
resolution of UUI
– PV Sling
• Chou et al J Urol 2003; 170: 494 2. Patients with MUI and no DO on CMG have outcomes
– TVT similar to those with pure SUI
• Rezapour and Ulmstem Int Urogynecol J 2001 (suppl 2)
S15-18 3. The type and degree of DO may also play a role in
outcome
Does this affect treatment or counseling?
Does UDS Predict Post-Op Voiding SISTEr Trial:
Dysfunction After PVS? Preop UDS Does Not Predict Post op Voiding Dysfunction
• Miller at al: J Urol 2003;169:2234 }
• Voiding dysfunction (VD) defined as:
– No contraction 19% retention, 18% delayed voiding – Catheterization for > 6 weeks
– Normal contraction, 0% retention 11.1% delayed voiding – Surgical takedown
– Valsalva void had no effect
• Iglesia et al: Obstet Gynecol 1998;91:577
– Objective failure = 54% for Valsalva vs. 17% for non-
Valsalva voiders (p=.011)
} Yes
• 57/655 (8.7) developed VD
– 8 Burch
– 49 PVS
– Median post-op catheterization = 23 days for Valsalva vs.
14 days for non-Valsalva voiders (p=.049)
• No preoperative UDS finding was associated with
• McLennan et al, Obstet Gynecol 1998;92:608
– Neither pdet nor Valsalva voiding predicted return to
normal voiding or retention
}
No
increased risk of VD
–
–
Non-intubated and pressure-flow study Qmax
PVR
– Change in pves or padb at Qmax
– Change in pdet at Qmax Lemack, et al Abstract Neurourol Urodyn
Presented at SUFU, 2008
2008;27(2):123
Summary of UDS for SUI Highest Yield for Urodynamics In SUI
Most studies that recommend against the routine use of • Simpler diagnostic tests are insufficient
UDS prior to SUI surgery do not include women with • Mixed incontinence
significant urge component
• Empiric treatments unsuccessful
• Presence and characteristics of DO has been shown to • Cannot demonstrate UI clinically
predict outcomes for patients with mixed symptoms • Prior incontinence or radical pelvic surgery
in some studies
• Pelvic radiation
• Data on pre op voiding parameters are contradictory • Known or suspected neurological disease
– Not much for midurethral synthetic slings • Significant voiding symptoms
• Elevated PVR

11. Urodynamics Before Non-
What Is ISD?
Conservative Treatment of SUI
• Do UDS if: • Concept introduced by McGuire and colleagues
– Results will help counsel the patient – Retrospective analysis of the results of anti-incontinence
– Unsure of diagnosis surgery
– There is a history of voiding symptoms or elevated PVR – Some women who multiple retropubic operations had a
– Determination of ALPP or other UDS parameters will deficient sphincteric mechanism characterized by an open
affect choice of surgery bladder neck and proximal urethra at rest with minimal or
no urethral descent during stress
• Do not do UDS if:
– You are going to treat the patient the same way no matter • ISD denotes an intrinsic malfunction of the urethral
what the findings and UDS will not influence how you
council the patient
sphincter, regardless of its anatomic position
Classification of Stress Incontinence
Blaivas and Olsson, J Urol 139:737, 1988
Pathophysiology of SUI
• Type 0 - typical history for SUI, hypermobility, but no
incontinence demonstrated Urethral
• Type I - bladder neck closed at rest, minimal hypermobility Hypermobility
(<2cm), incontinence with increased abdominal pressure
• Type IIA - Vesical neck closed and above inferior margin of
symphysis at rest. During stress vesical neck and proximal ISD
urethra open and there is rotational descent with incontinence
• Type IIB - Vesical neck is closed and situated at or below
inferior margin of symphysis at rest. During stress +/- added
descent, but the urethra opens and incontinence ensues Urethral Hypermobility + ISD ISD
• Type III - Vesical neck and proximal urethra open at rest. ONLY
Obvious urinary leakage with gravity or minimal All women with SUI have some degree of ISD because
abdominal pressure hypermobility often exists without SUI
Leakage at arrow = ALPP = 109cmH2O
UDS Measures of ISD
ALPP - Intravesical pressure at which urine leakage
occurs due to increased abdominal pressure in the
• Abdominal Leak Point Pressure (ALPP) absence of a detrusor contraction
– Valsalva leak point pressure (VLPP)
• Maximum Urethral Closure Pressure (MUCP)

12. Urethral Pressure Measurements 23 year old female with “total and
UPP – intraluminal pressure along length of urethra unaware incontinence”
• Maximal urethral pressure
(MUP)
– Maximum pressure of the
measured profile
• Maximum urethral closure
pressure (MUCP)
– Maximum difference between
the urethral and intravesical
pressures Gravitational Incontinence
• Functional profile length ALPP = 34 cmH2O
– Length of the urethra along Open bladder neck
which the urethral pressure Urethral pressure profile Type 3 SUI
exceeds the intravesical
pressure in women
What Is ISD?
• Portion or component of stress incontinence
not caused by a support defect (urethral
hypermobility)
Urodynamic Stress Incontinence – Lack of coaptation
with hypermobility and ALPP = 109 cmH2O – Deficiency of urethral musculature
How much ISD?
– Deficiency of submucosal layer
– Neurological injury
What is ISD and How is it Defined In
ISD What Does it Mean?
the Face of Urethral Hypermobility?
• Can the presence or degree of ISD be • SUI with lack of urethral mobility?
accurately determined or quantified in the face • ALPP < 60 cmH2O?
of urethral mobility? • ALPP < 90-100 cmH2O?
• MUCP < 20 cmH2O?
• Not the overall competency of the urethra, but
• Bump et al (1997) – correlation but lack of
the component that is independent of urethral
concordance between MUCP and ALPP
mobility?
• What does “ISD” mean when choosing a
treatment for SUI?

13. Comparing Measures of
Sphincter Function
Sphincter Function
• ALPP • We have traditional defined sphincter function
• MUCP in terms of a pressure measurement
• What about in volume of urine lost?
• Only ALPP requires the patient to actually
have SUI in order to measure • Which urethra is “worse”?
– ALPP = 65 cmH2O, 1 ml of urine loss
• Which urethra is “worse”?
– ALPP = 95 cmH2O, 30 ml urine lost
– Continent with MUCP of 40 cmH2O
– Incontinent with MUCP of 45 cmH2O
MUCP and ISD ALPP and ISD
Where Do The Numbers Come From? Where Do The Numbers Come From?
• Retrospective determination that a • MUCP and ALPP measured in 125 women with SUI
preoperative MUCP < 20 cmH2O resulted in • ALPP < 60 cmH2O
higher surgical failure rates 1 – All had high grade (3) incontinence (81% continuous leakage)
– 75% fixed urethra
• These patients represented a specific subtype
• ALPP 60-89 cmH2O
of SUI, type III
– 80% pronounced type II urethral hypermobility and grade 2-3
• In 1992 the term was redefined as ISD 2 incontinence
1. McGuire EJ. Urodynamic findings in patients after failure of stress incontinence • ALPP > 90 cmH2O
operations. Prog Clin Biol Res 1981; 78:351–354.
– Lesser grades of incontinence and minimal to gross
2. Urinary Incontinence Guideline Panel. Urinary incontinence in adults: clinical hypermobility (type I or II)
practice guideline. AHCPR publication no. 92-0038. Rockville, MD: Agency
for Health Care Policy and Research, Public Health and Human Services;1992. • ALPP unrelated to MUCP
McGuire, et al J Urol 1993; 150:1452-1455
Urethral Hypermobility vs. ISD
The Inference Fleischmann et al J Urol 169:999, 2003
• ALPP < 60 cmH2O = ISD
• ALPP 60 - 90 cmH2O = equivocal, a component of • No correlation of ALPP with hypermobility:
ISD – ALPP < 60 24% hypermobile
• ALPP > 90-100 cmH2O little or no ISD – ALPP 60-90 31% hypermobile
– ALPP > 90 41% hypermobile
• But if no hypermobility, SUI must be caused by ISD
• No correlation of hypermobility or ALPP with
number of incontinence episodes or pad weight
• Current technology does not permit a method to
distinguish between ISD and hypermobility
• ISD and hypermobility can coexist but do not
define discrete classes of patients
– Use parameters to characterize not classify

14. UPP – ICS Standardisation Subcommittee Ultimately What Do We Really
Lose, et al Neurourol Urodyn 21:258-260, 2002 Need To Know?
• Clinical utility of urethral pressure measurement is • Is there a measure of “ISD” (or urethral function)
unclear that predicts outcome of intervention?
• There are no urethral pressure measurements that: • More importantly is there a measure of ISD that can
help to select a procedure?
– Discriminate urethral incompetence from other disorders
– Provide a measure of the severity of the condition
• In 2008 that means outcomes for midurethral slings
– Provide a reliable indicator to surgical success and return to and different approaches and bulking agents
normal after successful intervention
• May also apply to conservative and other minimally
• Urethral pressure measurement is still first and invasive therapies
foremost a research tool
Measuring The Measures Stress Incontinence and POP
• Both ALPP and UPP lack standardization in • POP and SUI are associated conditions
– May coexist
the literature and are used indiscriminately – POP may be “protective” of SUI as it can cause kinking of
the urethra or and thus can “mask” SUI.
• Reports on outcomes of surgery based ALPP • Repair of POP in clinically continent women has been
and UPP (MUCP) are variable shown to result in post-op SUI in 11-22%
– Few study separate out urethral mobility – -Stanton, 1982; Borstad, Torkel, 1989
component
• Simultaneous anti-incontinence procedure at the time
– Will discuss more later of POP repair is a topic of much interest.
OCCULT
Stress Incontinence and POP SUI
• Clinical SUI – patient complains of the
symptom
Clinically and UDS
• Urodynamic SUI – demonstrated on a UDS UDS continent incontinent
study No pessary Pessary
• Occult SUI – demonstrated only when the
prolapse is reduced

15. With High Grade POP Treatment of Clinical SUI at the Time
When There is No Clinical SUI of POP repair
• Some endorse simultaneous prophylactic anti- • Procedures found to be effective for SUI are
incontinence procedure. also effective combined with POP repair
– Brubaker et al 2006 (CARE trial), Twiss et al 2007
– Midurethral synthetic slings (Groutz 2004)
• Some recommend evaluating for occult SUI prior to – Pubovaginal slings (Barnes, et al 2002)
POP repair and selectively performing an anti-
incontinence procedure. – Burch procedures (Brubaker, et al 2006)
– Chaikin et al 2000, Ghoniem et al 1994, Liang et al 2004
• Others believe that routine performance of an anti-
incontinence procedure in continent women may add
unnecessary morbidity.
– de Tayrac et al 2004, DeLancey 1996, Zimmern 1998
Occult SUI AUGS CARE Trial
2 prospective controlled studies with TVT Brubaker et al NEJM 2006;354(15):1557-1566
• de Tayrac et al, 2004 • 322 patients undergoing abdominal sacrocolpopexy
– 19 patients (11 TVT, 8 no TVT) randomized to Burch (157) vs. no Burch (165)
– No post op SUI in TVT group, 12.5% in no TVT group • 36% of women in each group had OSUI
(No difference) • SUI by one or more criteria (symptoms, stress
– Higher post op voiding dysfunction in TVT group testing, treatment) at 3 months post op
– No Burch 44.1% (24.5% bothersome)
• Liang et al, 2004 – Burch 23.6% (6.1% bothersome)
– Hysterectomy with A/P repair + TVT vs. no TVT • Significant postop SUI even if no OSUI
– OSUI diagnosed by pessary test – No Burch 38.2%
– TVT – 10% subjective SUI, 0% objective SUI – Burch 20.8% POSUI
– No TVT – 64.7 % subjective SUI, 53% objective SUI • No increase in retention or LUTS with Burch
UDS Protocol UDS Protocol
• If urodynamic or occult SUI - simultaneous • Looked at the risk of needing a second
MUSS procedure to correct something caused by the
– Exception for women at high risk for retention initial procedure
(Impaired contractility or retention preop) – Risk of intervention for post op SUI is the risk of
having a secondary sling or bulking agent
• If no urodynamic, or occult incontinence then – Risk of intervention for obstruction from a sling is
no anti-incontinence procedure the risk of needing a sling loosening, cutting or
urethrolysis
Ballert, et al AUA 2008 Ballert, et al AUA 2008

16. All Patients with
Ballert, et al Ballert, et al
Stage 3 or 4 Prolapse
AUA, 2008 105 AUA, 2008 105
Women women
50
50 55 Clinical
55 No
Clinical SUI No Clinical SUI Clinical SUI
SUI
10 24 40 10 No 31 24 No
40 31 UDS/OSUI UDS/OSUI UDS/OSUI UDS/OSUI
No No
UDS/OSUI UDS/OSUI MUSS NO MUSS MUSS No MUSS
UDS/OSUI UDS/OSUI
3 (9.7%)
3 (7.5%) 3 (30%) MUSS takedown 2 (8.3%)
NO MUSS MUSS NO MUSS MUSS intervention intervention
MUSS 1 (3.2%)
takedown SUI SUI
intervention SUI
Results What We Do
• ROI due to obstruction after MUSS placement – • For a transvaginal POP repair:
8.5% – If clinical, urodynamic or occult SUI perform
simultaneous anti-incontinence procedure
• ROI for SUI in patients with no clinical, UDS or • Exception for women at high risk for retention
occult SUI and no MUSS - 8.3% – Some elderly, impaired contractility, retention preop
– If no clinical or demonstrable SUI, no anti-
• ROI for SUI in patients with clinical SUI, but no incontinence procedure
MUSS - 30% • Up to surgeon to discuss pros and cons of a “completely
“prophylactic” procedure
• For an abdominal sacrocolpopexy consider and
• Overall ROI for SUI if MUSS placed - 1.4%
anti-incontinence procedure for most women
Conservative Therapies For
Incontinence
Timed
Reinforcement Voiding
Conservative Treatments for SUI: Delayed
Objective Review of The Data Education Behavioral
Voiding
Victor W. Nitti Modification
Dietary &
Pelvic Floor Lifestyle
Rehabilitation Changes
Fluid
Restriction

17. Pelvic Floor Rehabilitation PFMT Rationale
• Stress Incontinence
• PFMT (initial description by Kegel in 1948) – Strengthen pelvic floor musculature and thus urethral
support
• Vaginal cones – Regain the normal unconscious activation of pelvic floor
muscles during increases in abdominal pressure
– Learn voluntary activation of a compensatory mechanism
• Biofeedback
• Urge Incontinence
• Electrical stimulation – Contraction of striated paraurethral musculature causes
reflex inhibition of detrusor contractions
• Magnetic stimulation – Improved reflex inhibition of detrusor contractions
secondary to stronger pelvic floor muscles
PFMT Assessing Pelvic Floor Rehabilitation
• Protocols vary in description of: • Proceedings and recommendations from the 3rd
– Frequency and number of contractions
– Length of hold and relax periods International Consultation on Incontinence
– Strength and endurance periods (ICI) provides a comprehensive review of the
– Self vs. instructor taught literature and offers “guidelines”
• Level of evidence and quality of studies found to be – Wilson, et al In: Abrams P et al. Incontinence. 3rd
low in a recent meta analaysis (Latthe BJOG International Consultation on Incontinence;
2008;115:435-44 Monaco, June 26-29, 2004. 3rd Edition 2005
• Prior to beginning PFMT all women should be
assessed to make sure that they can do a voluntary
pelvic floor muscle contraction
Pelvic Floor Muscle Training vs No
Treatment, or Inactive Control Treatments, For
ICI Recommendation Urinary Incontinence in Women: Cochrane
Review, 2006
• Based on extrapolation of data from exercise • The Cochrane Incontinence Group Specialized Trials
science literature PFMT programs should Register was searched (Dec 1, 2004)
include: • Randomized or quasi-randomized trials in women with
– 3 sets of 8-12 slow velocity maximum voluntary stress, urge or mixed urinary incontinence
PFM contractions – One arm of the trial included pelvic floor muscle training
(PFMT)
– Sustained for 6-8 seconds – Another arm was a no treatment, placebo, sham, or other
– Preformed 3-4 times/week inactive control
– For at least 15-20 weeks • PFMT was defined as a program of repeated voluntary
pelvic floor muscle contractions taught and supervised
by a health care professional
Hay-Smith, EJC, Dumoulin C, Reprinted Jan 2008

18. Cochrane Review 2006
Cochrane Review 2006 Results
Authors’ Conclusions
• Thirteen trials involving 714 women (375 PFMT, 339 • Review provides some support for the widespread
controls) met the inclusion criteria, but only six trials recommendation that PFMT be included in first-line
conservative management for women with
(403 women) contributed data to the analysis stress, urge, or mixed, urinary incontinence
– Most studies were at moderate to high risk of bias, based on • Statistical heterogeneity reflecting variation in
the trial reports incontinence type, training, and outcome
– There was considerable variation in interventions measurement made interpretation difficult
used, study populations, and outcome measures • The treatment effect might be greater in younger
• Women who did PFMT were more likely to report women (in their 40’s and 50’s) with stress urinary
incontinence alone, who participate in a supervised
they were cured or improved than women who did not PFMT program for at least three months, but these
• PFMT women also experienced about one fewer and other uncertainties require testing in further trials
incontinence episodes per day
Hay-Smith, EJC, Dumoulin C, Reprinted Jan 2008
Hay-Smith, EJC, Dumoulin C, Reprinted Jan 2008
Biofeedback Biofeedback Efficacy
• Monitoring instruments to • Level 1 evidence that BF-assisted PFMT is no more
detect and display physiologic effective than PFMT alone for women with stress and
events or conditions mixed incontinence (3rd ICI)
– Also supported by review of Latthe BJOG, 2008
– Vaginal or anal probes
– Surface electrodes
• Clinicians may find occasions when BF is a useful
– Visual or auditory display adjunct to treatment for purpose of
– Intravaginal resistance devices teaching, motivation, compliance, etc
• Pressure-filled vaginal probe
• Best use would appear to be in women who cannot
identify PFM
– Large scale RTC’s needed to study this
Electrical Stimulation
3rd ICI Pharmacotherapy
• Lack of consistency in programs used to treat • Alpha-adrenergic drugs
women with SUI, UUI and MI – Inconsistent results, high AE’s
• Insufficient data to determine if ES is better than no • Duloxetine 5-HT NE reuptake inhibitor
treatment for women with USUI or DO – Available in Europe
– Withdrawn from FDA consideration for approval in US
• No benefit to adding ES to PFMT, but further – Pooled Analysis 52% reduction in median IEF vs. 33% for
investigation needed placebo (statistically significant)
– Available as Cymbalta, an depressant, in US
– Also supported by review of Latthe BJOG, 2008

19. Systematic Review: Randomized, Controlled
Estrogen For Incontinence Trials of Nonsurgical Treatments for Urinary
Incontinence in Women (NIH Conference)
• HERS - estrogen + progestin (Grady, 2001)* • 96 RCT’s and 3 systematic reviews
– Daily oral estrogen + progestin associated with worsening incontinence
in older postmenopausal women with weekly incontinence
• Compared with regular care, pelvic floor muscle training with or
without bladder training resolved urinary incontinence
– For PFME alone the effect size was inconsistent across studies
• WHI - estrogen +/- progestin (Hendrix, 2005)*
• Electrical stimulation failed to resolve urinary incontinence
– HRT was not beneficial in treating or preventing incontinence
– HRT increased the risk of developing incontinence in women who did
• Oral hormone administration increased rates of urinary
not have incontinence at start of study
incontinence compared with placebo in most RCTs (1243 pts)
– HRT worsened the characteristics of preexisting symptoms • Transdermal or vaginal estrogen resulted in inconsistent
improvement of urinary incontinence
• Hextal review of 87 studies (Maturitas 2002:36:83) • Adrenergic drugs did not resolve or improve urinary
incontinence
– No help for SUI or UUI
• Duloxetine compared with placebo improved but did not resolve
urinary incontinence, with no significant dose–response
• Estrogen no longer recommended as treatment or prevention of association
incontinence * Double-blind placebo controlled studies Shamliyan, et al Ann Int Med 2008;148(6):1-15
Bulking Agents as an Option
• Patient decisions on treatment are related to
expectations and level of risk
Minimally Invasive Office
• Although improvement more likely than
Procedures for SUI cure, safety and lack of convalescence remains
the main advantage
Harriette M. Scarpero
• No perfect agent, nothing yet proven superior
Collagen vs. Surgery Indications for Bulking Agent in 2007
Corcos et al: Urology 2005;65:898-904
• Patient or surgeon preference
• Multicenter RTC comparing collagen to • Severe comorbid disease
surgery (different operations done) • SUI in the face of late radiation effects
• Success rate 12 mos after collagen was lower • SUI after neobladder
than after surgery 53.1% vs 72.2% • Sling failure
• SUI after pessary placement
• General and disease specific QOL score by
validated instruments were similar in the two • MUI with significant detrusor overactivity
groups -bulking agent “tests” the effect of increased urethral
resistance prior to surgery
• Satisfaction between therapeutic groups was
not statistically significant

20. Bulking Agents
Complications of Bulking Agents
FDA Approved 2007
• Hematuria, pain • Bovine Collagen Contigen®
• UTI • Pyrolytic Carbon Particles Durasphere™
• Transient voiding dysfunction or retention • DMSO/ ethylene vinyl alcohol copolymer Tegress™
• Extrusion of material • Calcium hydroxylapatite Coaptite®
• Granulomatous reaction
• Prolapse of urethral mucosa Under Investigation
• Urethrovaginal fistula- rare in normal tissue • Hyaluronic acid and dextranomer Zuidex™
• Silicone Macroparticles Macroplastique®
Should Bulking Agents be Limited to the Bovine Collagen
Treatment of The Non-mobile Urethra Contigen
• Easy delivery
• Studies using collagen have show similar success in
mobile vs non-mobile urethras • Antigenic phenomena 2-4%
– Herschorn, et al J Urol 1999; 156:1305 • Begins to degrade in 12 weeks
– Corcos and Fournier, Urology 1999, 54:815 • Repeat or booster injection needed
– Bent et al, J Urol 2001, 166:1354 (multicenter) • Durability of success without further injections
(Herschorn et al.: J. Urol.: 156: 1305, 1996)
– 71% at 1 year
• Registration studies for new agents have specific
– 58% at 2 years
inclusion criteria
– 46% at 3 years
– Low ALPP
– Minimal urethral mobility
Collagen Results Summary Durasphere
• Pooling data from all studies, short term • Pyrolytic carbon coated
(1 year) outcomes are approximately: zirconium oxide beads
– 25% cure • No antigenicity
– 50% improved • Tends to plug device
– Likely extrusion of
– 25% failed
carrier first as less
viscous
• With 1-3 initial injections – Less likely with newer
formulation?

21. Durasphere Outcomes Durasphere Vs. Contigen
Lightner, et al Urology 58:13, 2001 Extended Follow-up
Chrouser et al, J Urol. 171:1152-5, 2004
• 355 patients treated in a randomized trial of
Durasphere (178) vs. Contigen (177)
– 115 Durasphere patients followed > 12 months • 56 women treated with Durasphere compared to age
• Mean # of injections = 1.69 vs. 1.55 for Contigen matched women treated with Contigen
– Telephone interview
• 12 month outcomes Durasphere vs. Contigen: • Tx initially effective in 63% of both
Patients followed 12 months from baseline: • At 24 and 36 mos:
– ↓ pad wt. 27.9 vs. 26.4 gm – Durasphere effective in 33% and 21%
– improved Stamey grade 66.1% vs. 65.8% – Contigen effective in 19% and 9%
– vol injected 7.55 vs 9.58 ml
• At last follow-up ( 51 and 62 mos) 21% in the
Durasphere group and 5% in the Contigen group felt
• Durasphere had a 31% cure (from FDA submission) tx was effective
Coaptite®
CaHC vs. Bovine Collagen
Calcium Hydroxylapatite
• Supplied in 1cc syringes • Randomized trial of women with SUI secondary to
• Most applications are 1- ISD based on ALPP
2 cc • Non inferiority study
• Easy Injection • Efficacy was determined by improvement on the
Stamey Urinary Incontinence Scale
• Standard – 0 dry
equipment, except 21 – 1leakage with vigorous activity
gauge needle – 2 leakage with minimal stress
• No special storage – 3leakage regardless of activity or position
• Non-allergic
• Patients allowed up to 5 injection in the first 6 months
Particle size 75-125 um Mayer, et al Urology 2007;69:876-830
Coaptite vs Contigen: Coaptite vs Contigen:
Results Results
• Improvement of > 1 Stamey grade at 6 months • Cure rate at 12 months
– Coaptite - 74% – Coaptite - 39%
– Collagen – 71% p=0.57 – Collagen – 37% p=0.78
• Improvement of > 1 Stamey grade at 12 months • 24 Hour Pad Weight Reduction of > 50% - 12 months
– Coaptite - 63.4% – Coaptite - 62% ITT 51%
– Collagen – 57.0% p=0.34 – Collagen – 54% p=0.23 38% p=0.055
• Intent to treat population (LOCF) • Mean change pad weight at 6 and 12 months
– Coaptite - 58% – Coaptite 19.5 g versus 17.2 g
– Collagen – 51% p=0.24 – Collagen 19.3g versus 31.4 g
Mayer, et al Urology 2007;69:876-830 Mayer, et al Urology 2007;69:876-830

22. Coaptite vs Contigen:
Stem Cells for SUI
Number of Injections
• Mean # injections • Aim of stem cell therapy is to
– Coaptite - 1.9 replace, repair, or enhance the biological
– Collagen - 2.0 function of urethral sphincter
• Only 1 injection
– Coaptite - 38% • Two types
– Collagen - 26.1% p = 0.03 – Embryonic stem cells
– Adult stem cells
Mayer, et al Urology 2007;69:876-830
Tissue Engineered Bulking Agents
• Multiple animal models
• Chondrocytes
• Detrusor myocytes
– Hypothesis: in native environment will retain their normal
differentiation and fxn
• Primary myoblasts
– Hypothesis: mass effect, ↑resistance, improve sphincter
function
• Autologous fibroblasts (bx from upper arm)
– 85% of 130 patients initially continent (Abstract #328)
Autologous stem cells are obtained with a biopsy of tissue, the cells are dissociated
and expanded in culture, and the expanded cells are implanted into the same host.
Furata et al Neurourol Urodyn 2007
Stem Cells for Bulking Agents Muscle Derived Stem Cells
• Muscle derived stem cells (MDSC) • Uniquely different from fibroblasts and smooth
– Differentiate into myogenic and non-myogenic lines muscle cells
• Skeletal derived satellite cells • Fuse to form post-mitotic multinucleated myotubes
– Myogenic precursors with limited differential potential – Limits persistent expansion and risk of obstruction
• Chondrocytes • Form myotubes and myofibers that become
– Arise from mesenchymal stem cells and have intrinsic innervated into the host muscle
ability to produce extracellular matrix (ECM) and cartilage – Serve as a bulking agent, but also may be physiologically
in vivo capable of improving urethral sphincter function.
• Adipose derived multipotent stem cells

23. Adipose Derived Stem Cells Stem Cells and Incontinence
• Have been shown to differentiate into • Chancellor et al, Urology 2006
adipogenic, myogenic, and osteogenic cells in
the presence of lineage-specific induction • Randomized, controlled comparison of MDCs
factors and fibroblasts for restoration of urethral
function in SD rats
• ADSCs exhibited the functional ability to • Nl, nontreated control, bilateral sciatic nerve
contract and relax in direct response to transection w/ periurethral injection of saline,
pharmacologic agents MDCs, fibroblasts, or MDC/fibroblast mixture
Stem Cells and Incontinence Stem Cells in Human Clinical Trials
• Histologic exam showed muscular atrophy in saline • Strasser et al. Autologous myoblasts & fibroblasts vs
group, and new striated muscle fibers at sites of MDC collagen for treatment of SUI in women: a RCT
injection in the MDC group but not fibroblast group
• 63 women with SUI
• LPP increased in both MDCs and fibroblast • Randomized to transurethral US guided
injection, but only MDCs improved the urethral injection of autologous myoblasts and
muscle strip contractility fibroblasts (42) or transurethral collagen (21)
• Urinary retention developed in the high dose • 1° outcomes: incontinence score 0-6 on
fibroblast group only VD, 24 hr pad test, questionnaire, contractility
& thickness of rhabdosphincter
Stem Cells in Human Clinical Trials Adult Stem Cell Therapy for SUI
Mitterberger et al BJU Int 2007
• ITT analysis • 123 women with SUI
• Follow up of 12 mos
• 12m follow up • Skeletal muscle biopsy from upper arm
Measure Autolgous cells Collagen
• Fibroblasts & myoblasts obtained and cultured x 7 weeks
• Using ultrasound guidance myoblasts injected into
Overall cure 38/42 2/21
rhabdosphincter
• submucosal injection offibroblast +collagen carrier
Incont score 6 →0 0 →0 • Pre and post injection eval with I-QOL, UDS, morphology &
fxn of urethra and rhabdosphincter
Thickness 2.13mm 3.38 2.32
p=< 0.0001
Contractility 1.56 0.67
0.58mm p=<0.0001

24. Adult Stem Cell Therapy for SUI
Mitterberger et al Eur Urol 2007
Stem Cell Therapy for SUI
• One year results • Stem cell therapy of SUI may the possibility
– 94/119 (79%) cured to morphologically and functionally
reconstruct the urethra and the rhabdosphincter
– 16/119 (13%) significantly improved
– 9/119 (8%) slightly improved
– 4 lost to follow up • Questions
– Cost
– Durability
– Patient selection
– Controlled trials
Radiofrequency Thermal Energy for
Transvaginal Radiofrequency
SUI
• Transvaginal delivery causes • Multicenter study of 120 women at 10 sites
replacement of endopelvic fascia – Non-randomized, non-controlled
with fibrotic tissue - – Urethral hypermobility and ALPP > 90 cmH2O
shortens, stiffens and thickens – Avg. operative time 30 min
fascia increasing urethral & – Avg. Temp 82º C
bladder neck support (75-90ºC)
Transvaginal – SURx System • Successful outcome “cured or improved” at 12
• Transurethral delivery (65-75ºC) months (109 patients) 73%
“causes tissue micro remodeling – 26% reported no IE’s
with creation of small regions of 4 RFe
– 66 (61%) objective cure on UDS
altered tissue compliance without electrodes – 39% extremely satisfied, 16% moderately satisfied
gross alteration in tissue Room temp – No complications reported
morphology” sterile H2O
Transurethral – Renessa Device Dmochowski, et al: J Urol 2003;169:1028-1032
Transurethral Radiofrequency Transurethral Radiofrequency
Lenihan: Am J Obstet Gynecol 2005;192:1995-2001
Appell RA, et al Neurourol Urodynam 2006;25:331-336
• 173 patients at 10 US sites (Novasys Medical) • 173 patients, evaluable population for QoL was 142, 89
• Urodynamic SUI, hypermobility, ALPP > 60 cmH2O treatment (80.1%) and 53 sham (84.1%)
• No prior surgical or bulking agent treatment • Results at 12 months (> 10 point improvement in QOL):
• Randomized to RF (110) or Sham (63) Treatment Sham
• Primary efficacy variable change in I-QOL of at least All patients 48% 44% p=0.7
10 points
Mod to severe SUI 74% 50% p=.03
• Only reported on those women with moderate to
severe SUI based on I-QOL 0-60 Mild SUI 20% 35% p=0.2
– 43 RF and 30 Sham Change in ALPP 13.2 cmH2O -2.0 cmH2O p=.02
• 74% of treated and 50% of sham had > 10 point
improvement in I-QOL (p=.03) • Dysuria only AE different among 2 groups 9.1%vs 1.6%

25. Transurethral Radiofrequency Radiofrequency for SUI
3 Year Data Summary
• 26 women available at 3 years • Minimal available data on transurethral and
– 5 underwent additional treatments for SUI transvaginal techniques
– 21 included in analysis • Transurethral seems less invasive with less
– 18 had IEF data requirement for anesthesia
– “office procedure”
• 50% achieved a 50% or greater reduction in IEF
• Primary efficacy outcome parameters are non-
– 3 patients no leaks on diary
traditional
– 3 patients worse
– How well does it really work?
– Median change -1 IEF/day
• No definitive advantage over bulking agents
Appell, et al Future Drugs 2007;4:1-7
Introduction of the Mid Urethral
Synthetic Sling In The Late 1990’s
• TVT introduced in 1996
Mid Urethral Slings: Indications, • Changed the way female stress incontinence is
treated
Techniques and Objective Data • Applicable to the majority of cases of female
SUI
Victor W. Nitti • Retropubic mid urethral synthetic sling is the
new “gold standard”
• Transobturator mid urethral sling introduced
later
Why have they become so popular? How important is the brand of sling?
• Proper mechanism of action to treat most SUI • Vast majority of data on TVT
• Easy for patient • A few comparative studies have shown equal efficacy
– Choice of anesthesia in the short term (e.g. TVT vs. SPARC)
• Easy for surgeon • For retropubic approach transvaginal appears equivalent
• Short operative time to suprapubic
• Low morbidity • Most important is the type of mesh
– Polypropylene, macropore, woven
• Rapid recovery
• Efficacy compares favorably to any other procedure • Each brand offers different features which may appeal
to different surgeons
• Introduction of transobturator approach – No distinct efficacy advantages as long as proper material
• “Homemade” slings show similar efficacy

26. Optimal Synthetic? Lateral Edge & Pore Pictures
• Monofilament
• Inert
• Large pore size
– Resist Infection
– Bacteria proliferate in TVT Advantage Mesh
micropores
– Macrophages unable to clear
bacteria if pore size <10 ObTape
microns*
– Tissue and blood vessel
ingrowth at pore size > 75 Loosely woven polypropylene
microns* Sparc/Monarc UreTex
* Based on data from hernia repair
Midurethral Slings
Examples of Midurethral Slings
Mechanism of Action
TVT SPARC • Dynamic kinking of the urethra with stress
• Both work without curing hypermobility
– TVT
• Atherton and Stanton, 2000
• Sarlos, et al, 2003
• Lo, et al 2004
LYNX – TOT
• Minaglia, et al, 2005
• Why do they sometimes work when there is no
hypermobility?
Randomized Trial of TVT vs. Colposuspension:
TVT Results 5 Year Follow up
Ward and Hilton BJOG 2008;115:226-33
• Large number of prospective studies in the Of 344 women 177 returned for f/u at 5 years and 119 had full
subjective and objective data set (72 TVT, 49CS)
literature by multiple authors from different Parameter TVT CS
countries show that at 1,2,3,4 and 5 years: Neg. 1 hour pad test* 81% 90% p=0.21
– Cure 84-88% De novo urgency 2% 5%
De novo UUI 1% 4%
– Significant improvement 7-10%
No leakage any circumstances 39% 46%
– Failure ~ 5-8% Cure stress leakage 63% 70%
Satisfied or very satisfied 91% 90%
Surgery for prolapse 1.8% 7.5% p=.025
Tape/suture complications 6pts. 0 pts.
TVT as effective in curing SUI as colposuspension at 5 years.
Effect of both procedures on cure of SI and increased QOL maintained in long term
* Primary outcome measure

27. Retropubic Midurethral
TVT 7 Year Data
Synthetic Slings
• 90 consecutive women with SUI had TVT • Literature supports use in
1995-1996 – Obese patients
• 80 available for followup – Elderly
• Mean followup 91 months (78-100) – Failed prior surgery
– Low ALPP or MUCP with hypermobility
• Subjective cure in 80 women = 81.3%
– Concurrent prolapse repair
– 16.3% improved
• Objective cure in 64 women = 84.4%
Nilsson, et al: Obstet Gynecol 2004;104:1259
Retropubic Midurethral
Outcomes of TVT in ISD and Non-ISD
Synthetic Slings Outcomes
• Reports for low ALPP and MUCP are mixed • Retrospective study of 111 patients
– Some show identical results – 31 with ISD
– 80 with non-ISD
• Decreased success with lower MUCP (<20) • ISD defined as:
• 74% vs. 85% cure - Rezapoor 2001
– ALPP < 60 cmH2O or MUCP < 20 cmH2O
– No mention of urethral mobility
– Overall success is probably slightly lower
– No mention of mobility
• No difference in cure rates at 12 months
– 74% for ISD
– 84% for non-ISD
Bai et al Int J Urogyn 2007
Urethral Mobility Not MUCP Predictive
Complications
of TVT Outcome
• Minor complications • Major Complications
• Urethral mobility determined on lateral cystogram
– Transient voiding – Tape erosion into urethra
• Mean f/u 9 months dysfunction or bladder
• Objective success based on urethral mobility (p=0.023) – Hematoma formation – Vascular injury &/or
– > 60° - 97%
– Bladder perforation (5%) Neuropathy
– 30-60° - 86%
– < 30° - 70% – Vaginal extrusion of tape – Bowel injury
• Strong association of urethral mobility and previous surgical – Urinary retention (2-3%)
failure
• No difference in success based on MUCP (p=0.65)
– < 20 cmH2O - 80%
– > 20 cmH2O - 85%
Fritel, et al: J Urol 2002; 168:2472-2475

28. Significant Complications Trans Obturator Slings
• Operative Injuries
– Major vascular, nerve, bowel, ureter • Avoid retropubic space
• Incidence of any = 0.08% 1 • Theoretical decrease in
– Bleeding requiring intervention potential complications
• 0.16 - 0.8% 1,2 – Bladder perforation reported
• Late • Like the retropubic seems
– Urinary tract erosion to work by dynamic
urethral kinking
• Can eliminate major vascular and bowel injury and • Theoretical decrease in
minimize erosion into the bladder if retropubic space voiding dysfunction
is avoided
1. Agostini, et al: Eur J Obstet Gynecol Reprod Biology 2006;124:237-239
2. Kolle, et al: Am J Obstet Gynecol 2005;193:2045-2049
Retropubic and Transobturator MUS
Trans Obturator Slings
Mechanism of Action
• Outside – In • Inside - Out • Dynamic kinking of the urethra with stress
– Mentor, AMS, Bard – TVT - Obturator • Both work without curing hypermobility
– Boston Scientific, etc – TVT
• Atherton and Stanton: BJOC 2000;107:1354-1359
• Sarlos et al: Int Urogynecol J 2003;14:385-388
• Lo et al: Urology 2004;63:671-675
– TOT
• Minaglia et al: Urology 2005;65:55-59
• Why do they sometimes work when there is no
hypermobility?
Transobturator Slings Obturator Anatomy
• Data on transobturator slings maturing
• Most data on the TOT (Mentor/Porges)
Adductor longus
– The Obtape and Uratape have had the highest insertion
complications and the material has actually
changed
Urethra
• Composition of the tape is most important Obturator canal
• No distinct advantage of brand or approach
(outside-in vs. inside-out)
– Surgeon preference Safe entry zone for needle insertion