OBJECTIVES: To assess the efficacy, safety and quality of life impact of the tension-free vaginal tape (TVT) procedure in the treatment of female stress urinary incontinence. MATERIALS AND METHODS: From November 1999 through May 2001, 32 TVT procedures performed by a single surgeon in the Department of Urology were prospectively analyzed. Preoperative work-up included a questionnaire regarding urinary symptoms and quality of life (QOL) assessment, a 1-hour pad test, voiding cystourethrography (VCUG), and urodynamic studies. The questionnaire, pad test, and uroflowmetry were repeated 6 months after the operation. RESULTS: The mean age of these women was 58.2 (range, 32 to 78) years, and the mean parity was 3.6 (range, 0 to 7); the mean operation time was 31.2±16.2 (range, 15-75) minutes. Bladder perforations occurred in 2 patients and were treated uneventfully with prolonged indwelling catheterization for 7 days; 87% of the women voided satisfactory immediately after catheter removal. The success rate (cure or improvement) was 93%. There was no significant change in urinary flow (maximal flow rate 21.8±6.9 ml/s preoperatively vs. 18.6±7.6 ml/s postoperatively, p>0.05) or percentage residual urine volume (8.7%±5.6% preoperatively vs. 10.3%±6.7% postoperatively, p>0.05). The QOL score improved from 4.9±1.6 to 1.7±1.3 (p<0.01). In addition to urinary incontinence, urinary frequency, nocturia, and urgency were also significantly improved by the operation. CONCLUSIONS: The TVT procedure is a promising technique that in this short-term analysis, appears to be safe and effective, producing substantial improvement in patients’ quality of life. Follow-up studies are warranted to evaluate the long-term outcome of this procedure.