INTRODUCTION AND HYPOTHESIS: The purpose of this study is to determine if the trans-obturator tape (TOT; Monarc, American Medical Systems (AMS)), which has been claimed to have similar or improved outcomes to retropubic mid-urethral slings, was equivalent (but not inferior) to the trans-vaginal tape (TVT; Gynecare) by using patient-reported outcomes for the treatment of urodynamic stress incontinence. METHODS: The primary outcome was the percentage cured of the symptom of stress urinary incontinence at 12 months on the International Consultation on Incontinence Modular Questionnaire-Female Lower Urinary Tract Symptoms question, 'does urine leak when you are physically active, exert yourself, cough or sneeze?'. Secondary outcomes included: quality of life, pain scores, global impression of improvement, patient satisfaction and complications. Objective assessments included cough stress test, urinary diary and pad test. RESULTS: At 12 months, 55 (65.5%) of the TVT group and 59 (63.4%) of the TOT group reported no stress incontinence. TOT was not inferior to TVT. There was less blood loss and pain with TOT than with TVT. There were improvements in quality of life, sexual function and patient satisfaction within groups but not between groups. CONCLUSION: Patient-reported outcomes have shown that TOT is not inferior to TVT, but both produce lower success rates than studies using objective measures.
RCT Entities:
INTRODUCTION AND HYPOTHESIS: The purpose of this study is to determine if the trans-obturator tape (TOT; Monarc, American Medical Systems (AMS)), which has been claimed to have similar or improved outcomes to retropubic mid-urethral slings, was equivalent (but not inferior) to the trans-vaginal tape (TVT; Gynecare) by using patient-reported outcomes for the treatment of urodynamic stress incontinence. METHODS: The primary outcome was the percentage cured of the symptom of stress urinary incontinence at 12 months on the International Consultation on Incontinence Modular Questionnaire-Female Lower Urinary Tract Symptoms question, 'does urine leak when you are physically active, exert yourself, cough or sneeze?'. Secondary outcomes included: quality of life, pain scores, global impression of improvement, patient satisfaction and complications. Objective assessments included cough stress test, urinary diary and pad test. RESULTS: At 12 months, 55 (65.5%) of the TVT group and 59 (63.4%) of the TOT group reported no stress incontinence. TOT was not inferior to TVT. There was less blood loss and pain with TOT than with TVT. There were improvements in quality of life, sexual function and patient satisfaction within groups but not between groups. CONCLUSION:Patient-reported outcomes have shown that TOT is not inferior to TVT, but both produce lower success rates than studies using objective measures.
Authors: Giacomo Novara; Walter Artibani; Matthew D Barber; Christopher R Chapple; Elisabetta Costantini; Vincenzo Ficarra; Paul Hilton; Carl G Nilsson; David Waltregny Journal: Eur Urol Date: 2010-04-23 Impact factor: 20.096
Authors: Bernard T Haylen; Dirk de Ridder; Robert M Freeman; Steven E Swift; Bary Berghmans; Joseph Lee; Ash Monga; Eckhard Petri; Diaa E Rizk; Peter K Sand; Gabriel N Schaer Journal: Int Urogynecol J Date: 2009-11-25 Impact factor: 2.894
Authors: Sue Ross; Magali Robert; Cheryl Swaby; Lorel Dederer; Doug Lier; Selphee Tang; Penny Brasher; Colin Birch; Dave Cenaiko; Tom Mainprize; Magnus Murphy; Kevin Carlson; Richard Baverstock; Philip Jacobs; Tyler Williamson Journal: Obstet Gynecol Date: 2009-12 Impact factor: 7.661
Authors: Matthew D Barber; Steven Kleeman; Mickey M Karram; Marie Fidela R Paraiso; Mark D Walters; Sandip Vasavada; Mark Ellerkmann Journal: Obstet Gynecol Date: 2008-03 Impact factor: 7.661
Authors: Jerry G Blaivas; Rajveer S Purohit; Matthew S Benedon; Gabriel Mekel; Michael Stern; Mubashir Billah; Kola Olugbade; Robert Bendavid; Vladimir Iakovlev Journal: Nat Rev Urol Date: 2015-08-18 Impact factor: 14.432