Objective: To evaluate the safety and efficacy of the tension-free vaginal tape procedure in the treatment of female stress urinary incontinence during the learning phase. Design: Retrospective clinical trial. Setting: Obstetrics and Gynecology Department, 2ndMedicalFaculty, Charles University and Faculty Hospital Motol, Prague. Methods: A group of first 20 patients with stress urinary incontinence who underwent tension-free vaginal tape procedure was studied. Surgical procedure was performed according to Ulmsten’s technique under the spinal anaesthesia. All patients were operated on by one surgeon and none had undergone any previous antiincontinence surgery. Preoperative evaluation consisted of urodynamic examination, Q-tip test, stress test, age, parity, body mass index, history of previous pelvic surgery and hormonal status. The cure rate and complications were determined in short-term postoperative follow-up. Results: The mean age was 59.5 (43–74) years, the median parity was 1.55 (1–2), 16 (80%) patients were slightly overweight (BMI 25–30 kg/m2) and others had normal weight (20–25 kg/m2). The cure rate in 6 months follow-up was 95% (19 of 20 patients). The complications occured in 7 (35%) cases. 5 (25%) patients had mild early postoperative complications (two lower urinary tract infections, one defect healing of vaginal suture, one urge symptomatology, one short-time urinary retention) and 2 (10%) had serious late postoperative complications (urethral diverticulum, retropubic haematoma) which required surgery (diverticulectomy, transabdominal evacuation of the haematoma). All complications were resolved and the patients were 6 month after the procedure free of negative postoperative symptoms. Conclusions: This study shows that tension-free vaginal tape procedure is an effective and safe minimally invasive surgical procedure in the treatment of stress urinary incontinence in short-term follow-up. The study also suggests that a learning phase of approximately 20 operations performed in a standard manner by one surgeon is required for good results. The operative technique is simple but theTVTprocedure should be performed by experienced urogynecologistswhoare able to resolve intraoperative and postoperative complications.

        Key words: tension-free vaginal tape, TVT, learning phase, learning curve, cure rate, safety