Five-year follow-up study of Monarc transobturator tape for surgical treatment of primary stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: We hypothesized that transobturator tape (TOT) is safe and efficacious for the treatment of urodynamic stress incontinence in the long term.

METHODS: We conducted a prospective study of patients with confirmed urodynamic stress incontinence (USI) who underwent a Monarc(TM) TOT procedure in a tertiary center between February 2006 and March 2009 without other concurrent surgical procedures. Urodynamics were conducted at 1 and 3 years postoperatively. Subjective evaluation included Incontinence Impact Questionnaire (IIQ-7), Urinary Distress Inventory Questionnaire (UDI-6), and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Objective cure was defined as no urinary leakage demonstrable on provocative filling cystometry and/ or 1-h pad test of <2 g. Subjective cure was based on a negative response to question 3 in UDI-6. Paired-samples t test, chi-square, and Fisher exact tests were applied; p < 0.05 was considered significant. The log-rank tests were used to compare event-free survival.

RESULTS: Sixty patients were enrolled, and 56 were evaluated at 5 years postoperatively. The majority were middle aged, postmenopausal, and overweight. Mean operating time was 31.1 ± 8.9 min, intraoperative complications were minor, and median period of follow-up was 80.3 ± 9.6 months. At 5 years of follow-up, objective and subjective cure rates were 89.3 % and 87.5 %, respectively. No mesh-related complications were seen. One patient needed a repeat midurethral sling procedure, and one patient each had bladder and bowel cancer.

CONCLUSION: Monarc TOT was safe and retained its high cure rate in the short- and long-term treatment of stress urinary incontinence.