Tunable tension tape versus transobturator tape in treatment of stress urinary incontinence in women: Randomized controlled trial.

INTRODUCTION: The synthetic mid-urethral slings are currently considered to be the most widely used technique for the surgical treatment of stress urinary incontinence (SUI). The most challenging aspect of the existing approaches is to achieve the optimal tension of the sling which treatment results are directly dependent on. To solve this problem, sling systems enabling an adjustment of the tension in the early postoperative period were created. A comparative study of the effectiveness and safety of such a system and a nonadjustable sling seems to be a relevant task.

MATERIALS AND METHODS: A double-blind, randomized, multicenter trial enrolled 320 patients with a mean age of 55.2 ± 11.2 years and confirmed SUI. Patients were randomized into two groups: the first group underwent a standard synthetic suburethral sling (transobturator tape [TOT]) procedure and the second group underwent a tunable tension tape sling (TTT) procedure. All patients underwent stress test, uroflowmetry and ultrasound scan to determine the postvoid residual volume. Urinary Distress Inventory Short Form 6, International Consultation on Incontinence Questionnaire-Short Form, Pelvic Organ Prolapse Incontinence Sexual Questionnaire 12 questionnaires were used to assess subjective efficacy.

RESULTS: Enhancement of prosthesis tension in the second group was required in 44 (28%) patients. Due to the possibility of tightening of the sling in the early postoperative period, the operation was effective in 143 (89%) patients in the adjustable sling group and in 109 (68%) patients in Group 1, p < 0.001. Loosening of the sling tension was performed in 25 (16%) patients in Group 2. The signs of obstructive voiding symptoms at the follow-up time of 36 months remained in Group 1 in 13 (8%) patients. Subjective satisfaction with treatment on the PGI-I scale was higher in Group 2: 100 (62%) versus 132 (82%), p < 0.001.

CONCLUSION: A synthetic mid-urethral TTT is superior to a standard nonadjustable sling in long-term effectiveness and safety.