[Clinical study on tension-free vaginal tape and tension-free vaginal tape obturator for surgical treatment of severe stress urinary incontinence].

OBJECTIVE: To investigate the clinical efficacy and improvement of patients' quality of life in tension-free vaginal tape (TVT) and tension-free vaginal tape obturator (TVT-O) for surgical treatment of severe female stress urinary incontinence. METHODS: This study was a randomized, single-blinded, controlled trial. Patients were randomized by a computer-generated randomization schedule with allocation to either TVT or TVT-O procedure. TVT procedure was performed in 35 cases and TVT-O in 34 cases. None had received surgery for urinary incontinence or was in pregnancy. Transvaginal hysterectomy and prolapse reparation were done simultaneously in some of the patients. All patients were requested to complete the Urinary Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7) as part of their pre- and postoperative assessment. RESULTS: All patients were evaluable and the mean follow-up was 14.5 months. The mean operative time was (18 +/- 5) min in the TVT-O group, significantly shorter than in the TVT group (27 +/- 5) min (P < 0.01). The two groups did not differ significantly in perioperative blood loss, postoperative complications (including tape erosion, pain in thigh or behind pubis), postvoid residual volume, hospital stays or expenses (all P > 0.05). Sixty patients were successfully treated for stress urinary incontinence (88.6% and 85.3% for TVT and TVT-O groups, respectively). There were significant improvements in postoperative scores for both the IIQ-7 and the UDI-6 (P < 0.01), except in subscale measuring symptoms of voiding dysfunction (P > 0.05). CONCLUSIONS: Both techniques appear to be equally effective in the surgical treatment of severe stress urinary incontinence in a short term review. Significant improvements could also be seen in patients' quality of life. However, TVT-O has a shorter operative time. No evidence of increasing risk of urethral obstruction after the operation could be found. Long term follow-ups are necessary to evaluate outcomes of different types of surgery for stress urinary incontinence.