Retropubic versus transobturator tension-free vaginal tape (TVT vs TVT-O): Five-year results of the Austrian randomized trial.

AIMS: To compare outcomes of the retropubic versus the transobturator tension-free vaginal tape (TVT vs TVT-O) at 5 years. METHODS: A total of 569 women undergoing surgery for primary stress incontinence were randomized to receive a retropubic or a transobturator tensionfree vaginal tape (TVT or TVT-O). Follow-up at 5 years included clinical examination, urodynamic studies and quality of life. The primary outcome measure was continence defined as a negative cough stress test at a volume of 300 mL. Secondary outcomes included urodynamic parameters, complications and quality of life.ClinicalTrials.gov (NCT 0041454). RESULTS: Three hundred and thirty-one patients (59%) were evaluated at 5 years (277 were seen, examined and completed questionnaires; 54 only completed questionnaires). No significant differences were seen in rates of a negative cough stress test (83% vs 76%, respectively), urodynamic parameters and complications. Quality-of-life improved significantly in both groups, without significant differences between the groups. Erosion rates were 5.2% and 4.5%, and reoperation rates were 4.1% and 3.2% respectively. CONCLUSIONS: At 5 years, subjective and objective results after TVT and TVT-O are stable and similar, without statistical significant differences between the procedures. Major long-term problems appear rare.

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

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).

Reoperation for pelvic organ prolapse within 10 years of primary surgery for prolapse.

INTRODUCTION AND HYPOTHESIS: A presumed high failure rate of conventional procedures for prolapse has been part of the rationale for new surgical approaches. The aim of the present retrospective cohort study was to estimate the reoperation rate for prolapse within 10 years of primary surgery for prolapse. METHODS: We identified all patients who underwent primary surgery for prolapse at four large regional centers in Austria in 1997 and 1998. Hospital databases were searched to determine whether patients had been reoperated for prolapse through 2008. RESULTS: A total of 456 patients underwent a primary operation for prolapse in 1997 and 1998. The most common primary operation was vaginal hysterectomy with colporrhaphy (89 %). We identified 13 reoperations for prolapse, for a 10-year reoperation rate of (at least) 2.9 %. The median interval between primary and secondary surgery was 5.5 years (range 1.5-10 years). CONCLUSION: The reoperation rate for prolapse after primary vaginal hysterectomy and colporrhaphy appears to be modest in this series of patients.

Transobturator tapes for stress urinary incontinence: Results of the Austrian registry.

OBJECTIVE: We established a voluntary registry to collect data on the perioperative course of transobturator tape operations for stress incontinence. STUDY DESIGN: Forty-seven centers completed a 1-page, 15-item questionnaire per procedure. RESULTS: Data on a total of 2543 operations with 11 different tape systems were collected. Intraoperative complications were noted for 120 procedures (4.7%). These included 85 cases of increased bleeding (3.3%), 10 vaginal perforations (0.4%), 10 bladder perforations (0.4%), and 2 urethral perforations. Reoperations attributable to the tape procedure were reported for 57 patients (24 tapes cut or loosened for voiding dysfunction, 11 vaginal erosions, 7 abscesses with erosions). One patient was reoperated at 14 days for a retropubic hematoma. There were no reports of bowel or major vessel injuries or mortality. Significant postoperative pain was reported for 12 patients (0.5%), although this was not specifically asked for in the questionnaire. CONCLUSION: Significant complications with transobturator tapes are uncommon. Bladder perforations occurred more frequently with outside-in than with inside-out techniques. Vaginal erosions, abscesses, and pain may be more common with transobturator than with retropubic tapes, and this may be due to the structure of the tapes rather than to the route of passage.