Incontinencia orina esfuerzo


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Incontinencia orina esfuerzo

  1. 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.
  2. 2. Meeting Disclaimer Regarding materials and information received, written or otherwise, during the 2008 American Urological Association Education and Research, Inc. Annual Meeting Instructional/Postgraduate MC/EC and Dry Lab Courses sponsored by the Office of Education: The scientific views, statements, and recommendations expressed in the written materials and during the meeting represent those of the authors and speakers and do not necessarily represent the views of the American Urological Association Education and Research, Inc.® Reproduction Permission Reproduction of all Instructional/Postgraduate, MC/EC and Dry Lab Courses is prohibited without written permission from individual authors and the American Urological Association Education and Research, Inc. These materials have been written and produced as a supplement to continuing medical education activities pursued during the Instructional/Postgraduate, MC/EC and Dry Lab Courses and are intended for use in that context only. Use of this material as an educational tool or singular resource/authority on the subject/s outside the context of the meeting is not intended. Accreditation The American Urological Association Education and Research, Inc. is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education (CME) for physicians. The American Urological Association Education and Research, Inc. takes responsibility for the content, quality, and scientific integrity of the CME activity. CME Credit The American Urological Association Education and Research, Inc. designates each Instructional Course educational activity for a maximum of 1.5 AMA PRA Category 1 credits™; each Postgraduate Course for a maximum of 3.25 AMA PRA Category 1 credits™; each MC Course for a maximum of 1.0 AMA PRA Category 1 credits™; each EC Course for a maximum of 2.0 AMA PRA Category 1 credits™; each MC Plus Course for a maximum of 2.0 AMA PRA Category 1 credits™; and each Dry Lab Course for a maximum of 2.5 AMA PRA Category 1 credits™. Physicians should only claim credits commensurate with the extent of their participation in the activity. Disclosure Policy Statement As a provider accredited by the Accreditation Council for Continuing Medical Education (ACCME), the American Urological Association Education and Research, Inc., must insure balance, independence, objectivity and scientific rigor in all its sponsored activities. All faculty participating in an educational activity provided by the American Urological Association Education and Research, Inc. are required to disclose to the audience any relevant financial relationships with any commercial interest to the provider. The intent of this disclosure is not to prevent a faculty with relevant financial relationships from serving as faculty, but rather to provide members of the audience with information on which they can make their own judgments. The American Urological Association Education and Research, Inc. must resolve any conflicts of interest prior to the commencement of the educational activity. It remains for the audience to determine if the faculty’s relationships may influence the educational content with regard to exposition or conclusion. When unlabeled or unapproved uses are discussed, these are also indicated. Evidence-based Content As a provider of continuing medical education accredited by the Accreditation Council for Continuing Medical Education (ACCME), it is the policy of the American Urological Association Education and Research, Inc. to review and certify that the content contained in this CME activity is evidence-based, valid, fair and balanced, scientifically rigorous, and free of commercial bias.
  3. 3. 2008 AUA Annual Meeting 11 EC Assessment and Management of Female Stress Urinary Incontinence 5/17/2008 6:00 - 8:00 p.m. Disclosures According to the American Urological Association’s Disclosure Policy, speakers involved in continuing medical education activities are required to report all relevant financial relationships with any commercial interest to the provider by completing an AUA Disclosure Form. All information from this form is provided to meeting participants so that they may make their own judgments about a speaker’s presentation. Well in advance of the CME activity, all disclosure information is reviewed by a peer group for identification of conflicts of interest, which are resolved in a variety of ways. The American Urological Association does not view the existence of relevant financial relationships as necessarily implying bias, conflict of interest, or decreasing the value of the presentation. Each faculty member presenting lectures in the Annual Meeting Instructional or Postgraduate, MC or EC and Dry Lab Courses has submitted a copy of his or her Disclosure online to the AUA. These copies are on file in the AUA Office of Education. This course has been planned to be well balanced, objective, and scientifically rigorous. Information and opinions offered by the speakers represent their viewpoints. Conclusions drawn by the audience members should be derived from careful consideration of all available scientific information. The following faculty members(s) declare a relationship with the commercial interests as listed below, related directly or indirectly to this CME activity. Participants may form their own judgments about the presentations in light of full disclosure of the facts. Faculty Disclosure Victor W. Nitti, M.D. Course Director Astellas: Consultant or Advisor Merke: Consultant or Advisor Novartis: Consultant or Advisor, Meeting Participant or Lecturer Pfizer: Meeting Participant or Lecturer; Consultant or Advisor Allergan: Consultant or Advisor, Scientific Study or Trial Ethicon: Consultant or Advisor Boehringer Ingelheim: Consultant or Advisor Eli Lilly: Consultant or Advisor Harriette M. Scarpero, M.D. Pfizer: Meeting Participant or Lecturer, Consultant or Advisor
  4. 4. Disclosure of Off-Label Uses The audience is advised that this continuing medical education activity may contain reference(s) to unlabeled or unapproved uses of drugs or devices. Please consult the prescribing information for full disclosure of approved uses. Faculty and speakers are required to disclose unlabeled or unapproved use of drugs or devices before their presentation or discussion during this activity. A special AUA value for your patients: is a joint AUA/AFUD patient education web site that provides accurate and unbiased information on urologic disease and conditions. It also provides information for patients and others wishing to locate urologists in their local areas. This site does not provide medical advice. The content and illustrations are for informational purposes only. This information is not intended to substitute for a consultation with a urologist. It is offered to educate the patient, and their families, in order for them to get the most out of office visits and consultations.
  5. 5. Commercial Support Acknowledgements AUA Office of Education thanks the companies and representatives who support continuing education of physicians with unrestricted educational grants, displays at educational meetings, and their expertise. This is a valuable resource to everyone. The AUA Office of Education salutes the following company for providing an educational grant in support of the Assessment and Management of Female Stress Urinary Incontinence course at the 2008 Annual Meeting. Ethicon Women’s Health and Urology The scientific programs and faculty are independently developed and finalized by the Chair of Education, the Director of Education and Scientific Program Director with no influence or input from these or any companies providing either an unrestricted educational grant or technical support. Comments or letters regarding this program and/or company involvement in an educational meeting may be addressed to: Jan Baum, M.A. Director of Education American Urological Association 1000 Corporate Boulevard Linthicum, MD 21090 (410) 689-3930
  6. 6. 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
  7. 7. 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
  8. 8. 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
  9. 9. 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
  10. 10. 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)
  11. 11. 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?
  12. 12. 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
  13. 13. 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
  14. 14. 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
  15. 15. 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
  16. 16. 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
  17. 17. 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
  18. 18. 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
  19. 19. 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?
  20. 20. 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
  21. 21. 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
  22. 22. 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
  23. 23. 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%
  24. 24. 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
  25. 25. 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
  26. 26. 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
  27. 27. 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