1164 TWENTY-FOUR-MONTH OUTCOMES OF RANDOMIZED EQUIVALENCE TRIAL OF RETROPUBIC AND TRANSOBTURATOR MIDURETHRAL SLINGS (TOMUS)

Abstract

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Incontinence - Evaluation & Therapy1 Apr 20111164 TWENTY-FOUR-MONTH OUTCOMES OF RANDOMIZED EQUIVALENCE TRIAL OF RETROPUBIC AND TRANSOBTURATOR MIDURETHRAL SLINGS (TOMUS) Michael Albo, Heather Litman, Gary Lemack, Holly Richter, Toby Chai, Kimberly Kenton, Stephen Kraus, Larry Sirls, Halina Zyczynski, Peggy Norton, Ann Gormley, and John Kusek Michael AlboMichael Albo San Diego, CA More articles by this author , Heather LitmanHeather Litman Watertown, MA More articles by this author , Gary LemackGary Lemack Dallas, TX More articles by this author , Holly RichterHolly Richter Birmingham, AL More articles by this author , Toby ChaiToby Chai Baltimore, MD More articles by this author , Kimberly KentonKimberly Kenton Maywood, IL More articles by this author , Stephen KrausStephen Kraus San Antonio, TX More articles by this author , Larry SirlsLarry Sirls Royal Oak, MI More articles by this author , Halina ZyczynskiHalina Zyczynski Pittsburgh, PA More articles by this author , Peggy NortonPeggy Norton Salt Lake City, UT More articles by this author , Ann GormleyAnn Gormley Hanover, NH More articles by this author , and John KusekJohn Kusek Bethesda, MD More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2011.02.774AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Transobturator and retropubic midurethral slings (TMUS and RMUS) are common surgical techniques for women with stress urinary incontinence (SUI), but their longer-term comparative efficacy is unknown. We assessed 24-month outcomes in a randomized equivalence trial of TMUS and RMUS. METHODS Primary outcomes were objective and subjective SUI cure rates at 12 and 24 months after surgery; 12-month outcomes were reported previously. Objective cure was defined as a negative stress test, negative pad test and no retreatment. Subjective cure was defined as no self-reported SUI symptoms, no leakage episodes on 3-day bladder diary and no retreatment. An equivalence margin of +/- 12% was established a priori. The primary analysis for equivalence was per protocol (assigned surgery performed); all other analyses were intention-to-treat. Secondary outcomes included persistent or de novo urge incontinence; voiding dysfunction and mesh complications; patient satisfaction, and scores on Urinary Distress Inventory (UDI) and Incontinence Impact Questionnaire (IIQ). RESULTS 516 (88.5%) of 583 randomized participants who received the assigned surgery completed the 24-month assessment. Mean age was 53 + 11 years. Objective success rates for RMUS and TMUS were 77.3% and 72.3%, respectively (95% CI for difference of 5.1%: -2.0, 12.1%). Subjective success rates were 55.7% and 48.3% (CI for difference of 7.4%: -0.7, 15.5%). The statistical test for equivalence was inconclusive for both objective and subjective success. No differences were noted between the groups with regard to patient satisfaction (RMUS 86.3% vs. TMUS 88.1%, p=0.58), change in total UDI scores (RMUS 100 vs. TMUS 107, p =0.13), change in total IIQ scores (RMUS 125 vs. TMUS 124, p=0.89), de novo urge incontinence (RMUS 0% vs. TMUS 0.3%, p= 0.99), persistent urge incontinence (RMUS 14.1% vs. TMUS 12.7%, p=0.63) or mesh exposure (RMUS 1.3% vs. TMUS 0.7%, p=0.41). Similar to findings at 12 months, the RMUS group had higher rates of voiding dysfunction requiring surgery (3.0% vs. 0%, p=0.002) and urinary tract infections (17.1% vs. 10.7%, p=0.025), and the TMUS group had a higher rate of neurologic symptoms (4.4% vs. 9.4%, p=0.023). CONCLUSIONS Although objective outcomes of RMUS and TMUS were equivalent at 12 months, 24-month objective and subjective cure rates did not meet predefined criteria for equivalence. Patient satisfaction remained high and symptom severity remained markedly improved compared to baseline for both groups. No additional differences in adverse events were identified. © 2011 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 185Issue 4SApril 2011Page: e467 Peer Review Report Advertisement Copyright & Permissions© 2011 by American Urological Association Education and Research, Inc.MetricsAuthor Information Michael Albo San Diego, CA More articles by this author Heather Litman Watertown, MA More articles by this author Gary Lemack Dallas, TX More articles by this author Holly Richter Birmingham, AL More articles by this author Toby Chai Baltimore, MD More articles by this author Kimberly Kenton Maywood, IL More articles by this author Stephen Kraus San Antonio, TX More articles by this author Larry Sirls Royal Oak, MI More articles by this author Halina Zyczynski Pittsburgh, PA More articles by this author Peggy Norton Salt Lake City, UT More articles by this author Ann Gormley Hanover, NH More articles by this author John Kusek Bethesda, MD More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...