INTRODUCTION AND HYPOTHESIS: The purpose of the study was to evaluate and compare the clinical values of tension-free vaginal tape (TVT), tension-free vaginal tape-transobturator (TVT-O), or tension-free vaginal tape-Secur (TVT-Secur) as treatment for female stress urinary incontinence. METHODS: The pre-operative and 1-year post-operative follow-up protocols for patients who were treated with serial mid-urethral tension-free tape procedures in two hospitals from October 2008 to December 2009 were prospectively studied. These patients were randomly allocated to TVT, TVT-O, or TVT-Secur. RESULTS: A total of 102 women participated. At the 1-year follow-up, complications were not statistically different across the three groups except for pain in the thigh, which was more common in the TVT-O group. The overall efficacy and cure rate were similar between the TVT and TVT-O groups, but were significantly lower in the TVT-Secur group. CONCLUSIONS: A comparison of the three procedures shows that TVT-O is easy to operate and is as safe as TVT-Secur, and it has similar long-term efficacy to TVT, though, as one of the third-generation mid-urethral tension-free tapes, TVT-Secur is still being evaluated. Basing on the outcome of our study, it had rare complications but unsatisfactory efficacy, and we suggest that TVT-Secur is not fit for severe cases. However, observation and comparison of these groups in a larger sample size on a longer term are needed.
RCT Entities:
INTRODUCTION AND HYPOTHESIS: The purpose of the study was to evaluate and compare the clinical values of tension-free vaginal tape (TVT), tension-free vaginal tape-transobturator (TVT-O), or tension-free vaginal tape-Secur (TVT-Secur) as treatment for female stress urinary incontinence. METHODS: The pre-operative and 1-year post-operative follow-up protocols for patients who were treated with serial mid-urethral tension-free tape procedures in two hospitals from October 2008 to December 2009 were prospectively studied. These patients were randomly allocated to TVT, TVT-O, or TVT-Secur. RESULTS: A total of 102 women participated. At the 1-year follow-up, complications were not statistically different across the three groups except for pain in the thigh, which was more common in the TVT-O group. The overall efficacy and cure rate were similar between the TVT and TVT-O groups, but were significantly lower in the TVT-Secur group. CONCLUSIONS: A comparison of the three procedures shows that TVT-O is easy to operate and is as safe as TVT-Secur, and it has similar long-term efficacy to TVT, though, as one of the third-generation mid-urethral tension-free tapes, TVT-Secur is still being evaluated. Basing on the outcome of our study, it had rare complications but unsatisfactory efficacy, and we suggest that TVT-Secur is not fit for severe cases. However, observation and comparison of these groups in a larger sample size on a longer term are needed.
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Authors: Ana Maria H M Bianchi-Ferraro; Zsuzsanna I K Jarmy-DiBella; Rodrigo de Aquino Castro; Maria Augusta T Bortolini; Marair G F Sartori; Manoel J B C Girão Journal: Int Urogynecol J Date: 2014-03-19 Impact factor: 2.894
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