Randomized trial of graft materials in transobturator tape operation: biological versus synthetic.

objectiveTo compare the outcome of outside-in biological and synthetic transobturator tape (TOT) operation, including subjective and objective success rates, urodynamics, and quality of life. MATERIALS AND

methodsOne hundred patients suffering from clinical and/or urodynamic stress urinary incontinence (SUI) were randomized into biological material TOT (PELVILACE® TO) or synthetic material TOT (ALIGN®TO Urethral Support System) groups. Preoperative and at 1 year postoperative urogynecological symptom assessment, 1-h pad test, 4-day bladder diary, stress test, Q-tip test, and urodynamics were performed. For the evaluation of quality of life, the King's Health Questionnaire, Urogenital Distress Inventory-6, Incontinence Impact Questionnaire-7, and Prolapse Quality of Life were used.

resultsThere was no significant difference between the two groups regarding objective and subjective cure rates and quality of life. At 1-year follow-up, the subjective cure rate was 68 % in the biological material TOT and 70 % in the synthetic material TOT group. No perioperative complications developed. Groin pain developed in 2 patients in the biological TOT group and 1 patient had dehiscence in the periurethral incision, which healed with local estrogen. Two patients had transient urinary retention in the synthetic TOT group, 1 patient developed groin pain, and 1 patient had mesh erosion observed at the 1-year follow-up.

conclusionTransobturator tape with biological material in the management of SUI has a rate of success and patient satisfaction similar to those of synthetic material at 1-year follow-up. Studies with longer follow-up and larger cohorts are necessary to evaluate possible autolysis and degradation of biological slings and a possible reduction in efficacy over time.