Safety and Efficacy of the TVT Procedureduring the Learning Phase

Overview

Objective:
To evaluate the safety and efficacy of the tension-free vaginal tape procedure in thetreatment of female stress urinary incontinence during the learning phase.Design: Retrospective clinical trial.Setting: Obstetrics and Gynecology Department, 2ndMedicalFaculty, Charles University and FacultyHospital Motol, Prague.Methods: A group of first 20 patients with stress urinary incontinence who underwent tension-freevaginal tape procedure was studied. Surgical procedure was performed according to Ulmsten’stechnique under the spinal anaesthesia. All patients were operated on by one surgeon and none hadundergone any previous antiincontinence surgery. Preoperative evaluation consisted of urodynamicexamination, Q-tip test, stress test, age, parity, body mass index, history of previous pelvicsurgery and hormonal status. The cure rate and complications were determined in short-termpostoperative follow-up.Results: The mean age was 59.5 (43–74) years, the median parity was 1.55 (1–2), 16 (80%) patients wereslightly overweight (BMI 25–30 kg/m2) and others had normal weight (20–25 kg/m2). The cure rate in6 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 defecthealing of vaginal suture, one urge symptomatology, one short-time urinary retention) and 2 (10%)had serious late postoperative complications (urethral diverticulum, retropubic haematoma) whichrequired surgery (diverticulectomy, transabdominal evacuation of the haematoma). All complicationswere resolved and the patients were 6 month after the procedure free of negative postoperativesymptoms.Conclusions: This study shows that tension-free vaginal tape procedure is an effective and safeminimally invasive surgical procedure in the treatment of stress urinary incontinence in short-termfollow-up. The study also suggests that a learning phase of approximately 20 operations performedin a standard manner by one surgeon is required for good results. The operative technique is simplebut theTVTprocedure should be performed by experienced urogynecologistswhoare able to resolveintraoperative and postoperative complications.

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