INTRODUCTION AND HYPOTHESIS: A study was conducted to compare the efficacy and complications of TVT and TVT-O. METHODS: This study is a prospective randomized trial involving 300 women with primary SUI; 149 received TVT, and 151 patients were treated withTVT-O. At the 1 year follow-up, 141 TVT patients and 147 TVT-O patients (dropout, 5.3% and 2.6%) were evaluated using urodynamic studies, validated questionnaires, and a 1-h pad test. RESULTS: The mean operating time was shorter in the TVT-O group (p < 0.001). Urinary retention was not significantly different (p > 0.05). Inner thigh discomfort was reported by 5.4% of TVT-O patients. In the TVT and the TVT-O groups, respectively, 90.1% and 88.4% women were objectively cured. The satisfaction with the surgical outcome reflects the significant decrease in the questionnaire mean symptom scores in both groups. Postoperative de novo urgency was significantly more common in the TVT-O patients (p = 0.015). CONCLUSION: The groups showed comparable objective and subjective cure rates.
RCT Entities:
INTRODUCTION AND HYPOTHESIS: A study was conducted to compare the efficacy and complications of TVT and TVT-O. METHODS: This study is a prospective randomized trial involving 300 women with primary SUI; 149 received TVT, and 151 patients were treated with TVT-O. At the 1 year follow-up, 141 TVTpatients and 147 TVT-Opatients (dropout, 5.3% and 2.6%) were evaluated using urodynamic studies, validated questionnaires, and a 1-h pad test. RESULTS: The mean operating time was shorter in the TVT-O group (p < 0.001). Urinary retention was not significantly different (p > 0.05). Inner thigh discomfort was reported by 5.4% of TVT-Opatients. In the TVT and the TVT-O groups, respectively, 90.1% and 88.4% women were objectively cured. The satisfaction with the surgical outcome reflects the significant decrease in the questionnaire mean symptom scores in both groups. Postoperative de novo urgency was significantly more common in the TVT-Opatients (p = 0.015). CONCLUSION: The groups showed comparable objective and subjective cure rates.
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