Objective: The aim of this study is to present our first experience with a novel modification of the tension-free sling idea and to evaluate the safety and efficacy of this new procedure for the treatment of stress urinary incontinence in women.
Study design: Eighty-five women with previously untreated stress urinary incontinence were recruited to participate in a clinical study. The efficacy of this surgical procedure was evaluated perioperatively and 3 months (+/-1 week) after operation--objectively by cough test and subjectively by the questionnaires Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire and the International Consultation on Incontinence Questionnaire-Short Form. All data were processed and statistical analyses performed in statistical environment R, version 2.5.1.
Results: From our results we conclude that there were no perioperative complications, objectively 62% of these patients were completely dry and 25% of patients improved. We observed a higher proportion of vaginal wall erosion (7/85) and urgency de novo (5/85) in the learning period group with respect to the routine period group.
Conclusions: Our first experience with the tension-free vaginal tape secur system procedure is that it has a low percentage of perioperative complications. The learning curve has to be taken in account with reference to postoperative complications.