A randomized comparison of a single-incision needleless (Contasure-needleless®) mini-sling versus an inside-out transobturator (Contasure-KIM®) mid-urethral sling in women with stress urinary incontinence: 24-month follow-up results.

INTRODUCTION AND HYPOTHESIS: There is a shortage of reliable data on the efficiency of the under-investigated mini-slings to treat stress urinary incontinence (SUI). We aimed to compare the effectiveness of the single-incision needleless mini-sling (SIMS) with the transobturator inside-out mid-urethral sling (TOT).

MATERIALS AND METHODS: Two hundred one women with clinically proven SUI were included in this single-center prospective randomized trial. The patients were randomly allocated to the groups. All surgeries were done by the same single surgeon. Examinations were done by one other blinded surgeon. The patients were followed up for 24 months. Objective cure was defined as the absence of SUI and negative cough-stress test. Subjective cure was defined as no stress leakage of urine after surgery in a validated questionnaire. Failure of the surgery was defined as the need for reoperation. Every complaint was categorized by the IUGA/ICS Classification of Prosthesis-related Complications.

RESULTS: The objective (85.4% versus 89.9%, p = 0.362) and subjective (87.6% versus 89.9%, p = 0.636) cure rates were similar with the TOT and SIMS at the postoperative month 24, respectively. The mesh exposure ≤ 1 cm rate was 3.4% for both groups, and the mesh exposure > 1 cm rate was 2.2% for both groups. Overall failure rates were 3.4% and 2.2% for the TOT and SIMS group, respectively. No viscus organ perforation was noted. Complications with the SIMS procedure were less painful compared with TOT (p = 0.024).

CONCLUSIONS: Single-incision needleless mini-slings exhibited similar cure rates as the trans-obturator mid-urethral slings from both the patient and clinician points of view in 24 months of follow-up. Mini-slings resulted in significantly less postoperative pain than trans-obturator mid-urethral slings.