Retropubic vs. transobturator tension-free vaginal tape for female stress urinary incontinence: 3-month results of a randomized controlled trial.

Aigmüller, Thomas; Tammaa, Ayman; Tamussino, Karl; Hanzal, Engelbert; Umek, Wolfgang; Kölle, Dieter; Kropshofer, Stephan; Bjelic-Radisic, Vesna; Haas, Josef; Giuliani, Albrecht; Lang, Peter; Preyer, Oliver; Peschers, Ursula; Jundt, Katharina; Ralph, George; Dungl, Andrea; Riss, Paul

Background: We conducted a prospective randomized controlled noninferiority trial to compare objective and subjective outcomes of retropubic tension-free vaginal tape (TVT) with those of transobturator tape (TVT-O) as primary treatment for stress urinary incontinence (SUI) in women. Study design: The study was conducted at 25 gynecology units in Austria and Germany; regional and academic hospitals participated. A total of 569 patients were randomly assigned to undergo TVT or TVT-O. Results: A total of 480 patients (85 %) were examined at 3 months. A negative cough stress test with stable cystometry to 300 ml was seen in 87 % of patients after TVT and in 84 % after TVT-O; 64 % and 59 % of patients, respectively, reported no pad use, and 88 % of patients in both groups considered themselves much or very much better on the Patient Global Impression of Improvement (PGI-I) scale. Quality of life (QoL) as assessed with the SF-12 Health Survey, Kings' Health Questionnaire, (KHQ), and EuroQol-5D (EQ-5D) was significantly improved in both arms, with no differences between arms. There were no significant differences in postoperative pain or complications. Conclusions: Results of this trial demonstrate noninferiority between TVT and TVT-O with regard to postoperative continence and QoL and suggest little difference in perioperative problems (ClinicalTrials.gov NCT 00441454).

URINARY stress incontinence; URINARY incontinence; UROGYNECOLOGY; DISEASES in women; CYSTOMETRY

International Urogynecology Journal, 2014, Vol 25, Issue 8, p1023

0937-3462

Academic Journal

10.1007/s00192-014-2384-z