INTRODUCTION AND HYPOTHESIS: This is a randomized multicenter study comparing two mid-urethra tape procedures, the tension-free vaginal tape (TVT) with the tension-free vaginal tape-obturator (TVT-O) in terms of cure rate and complication rate. METHODS:Seven Finnish hospitals participated. Power calculations required 130 women in each group to detect a 10% difference in cure rate. A total of 267 underwent the allocated operation. Follow-up was scheduled at 2, 12, 36 and 60 months. A cough stress test was used as an objective outcome measure. Subjective outcome was assessed by five different condition-specific quality of life questionnaires. RESULTS: At 36 months of follow-up, 96% of the patients were evaluated. Objective cure rate was 94.6% in the TVT group and 89.5% in the TVT-O group (p = 0.131). Subjective cure rates were significant with no difference between the groups. CONCLUSION: The TVT and the TVT-O are equally effective in the treatment of stress urinary incontinence after 36-month follow-up with no difference in complication rates.
RCT Entities:
INTRODUCTION AND HYPOTHESIS: This is a randomized multicenter study comparing two mid-urethra tape procedures, the tension-free vaginal tape (TVT) with the tension-free vaginal tape-obturator (TVT-O) in terms of cure rate and complication rate. METHODS: Seven Finnish hospitals participated. Power calculations required 130 women in each group to detect a 10% difference in cure rate. A total of 267 underwent the allocated operation. Follow-up was scheduled at 2, 12, 36 and 60 months. A cough stress test was used as an objective outcome measure. Subjective outcome was assessed by five different condition-specific quality of life questionnaires. RESULTS: At 36 months of follow-up, 96% of the patients were evaluated. Objective cure rate was 94.6% in the TVT group and 89.5% in the TVT-O group (p = 0.131). Subjective cure rates were significant with no difference between the groups. CONCLUSION: The TVT and the TVT-O are equally effective in the treatment of stress urinary incontinence after 36-month follow-up with no difference in complication rates.
Authors: Dieter Kölle; Karl Tamussino; Engelbert Hanzal; Ayman Tammaa; Oliver Preyer; Arnim Bader; Hermann Enzelsberger; George Ralph; Paul Riss Journal: Am J Obstet Gynecol Date: 2005-12 Impact factor: 8.661
Authors: Aura Pyykönen; Pasi Aronen; Pirjo Räsänen; Risto P Roine; Jari Sjöberg; Anna-Maija Tapper Journal: Int Urogynecol J Date: 2013-09-06 Impact factor: 2.894
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