Ayman Tammaa1, Thomas Aigmüller2, Engelbert Hanzal3, Wolfgang Umek3, Stephan Kropshofer4, Peter F J Lang5, George Ralph6, Paul Riss7, Dieter Koelle8, Katharina Jundt9, Karl Tamussino2, Vesna Bjelic-Radisic2. 1. Department of Obstetrics and Gynecology, Wilhelminenspital, Vienna, Austria. 2. Division of Gynecology, Medical University of Graz, Graz, Austria. 3. Division of Gynecology and Gynecologic Oncology, Medical University of Vienna, Vienna, Austria. 4. Department of Obstetrics and Gynecology, Medical University of Innsbruck, Innsbruck, Austria. 5. Department of Gynecology Krankenhaus der Barmherzigen Brüder Graz, Graz, Austria. 6. Department of Obstetrics and Gynecology, Landeskrankenhaus Leoben, Leoben, Austria. 7. Department of Obstetrics and Gynecology, Landesklinikum Mödling, Mödling, Austria. 8. Department of Obstetrics and Gynecology, Krankenhaus Schwaz, Schwaz, Austria. 9. Department of Obstetrics and Gynecology, University of Munich, Munich, Germany.
Abstract
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.
RCT Entities:
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.
Authors: Rosa Maria Laterza; Ksenia Halpern; Daniela Ulrich; Alexandra Graf; Karl Tamussino; Wolfgang Umek Journal: PLoS One Date: 2018-08-16 Impact factor: 3.240