OBJECTIVE: To compare the safety and efficacy of an inexpensive-modified transobturator vaginal tape procedure with the transobturator tension-free vaginal tape (TVT-O) procedure for the surgical treatment of female stress urinary incontinence (SUI). MATERIALS AND METHODS:Patients with SUI were randomly allocated to either the test group receiving the inexpensive-modified transobturator vaginal tape procedure or the control group receiving the GYNECARE TVT-O procedure. Treatment outcomes and Quality-of-life scores were recorded and analyzed between two groups. RESULTS:A total of 156 patients were enrolled in this trial. Eighty patients underwent the modified transobturator vaginal tape procedure. Among them 75(93.8%) were cured and 5(6.2%) were improved. The rest of the 76 patients underwent the GYNECARE TVT-O procedure with a 92% (70 of 76) cure rate and an 8% (6 of 76) improvement rate. No inefficient or aggravated cases occurred in both groups. The success rates between groups had no significant statistic difference (p > 0.05). The operative time, blood loss, hospital stay, and medical cost were significantly lower in the test group (p < 0.01); the increases in Quality-of-life scores were comparable between groups. CONCLUSIONS: The modified transobturator vaginal tape procedure is an efficacious and economic surgical treatment for female SUI.
RCT Entities:
OBJECTIVE: To compare the safety and efficacy of an inexpensive-modified transobturator vaginal tape procedure with the transobturator tension-free vaginal tape (TVT-O) procedure for the surgical treatment of female stress urinary incontinence (SUI). MATERIALS AND METHODS:Patients with SUI were randomly allocated to either the test group receiving the inexpensive-modified transobturator vaginal tape procedure or the control group receiving the GYNECARE TVT-O procedure. Treatment outcomes and Quality-of-life scores were recorded and analyzed between two groups. RESULTS: A total of 156 patients were enrolled in this trial. Eighty patients underwent the modified transobturator vaginal tape procedure. Among them 75(93.8%) were cured and 5(6.2%) were improved. The rest of the 76 patients underwent the GYNECARE TVT-O procedure with a 92% (70 of 76) cure rate and an 8% (6 of 76) improvement rate. No inefficient or aggravated cases occurred in both groups. The success rates between groups had no significant statistic difference (p > 0.05). The operative time, blood loss, hospital stay, and medical cost were significantly lower in the test group (p < 0.01); the increases in Quality-of-life scores were comparable between groups. CONCLUSIONS: The modified transobturator vaginal tape procedure is an efficacious and economic surgical treatment for female SUI.