A randomized comparison of a single-incision needleless (Contasure-needleless®) mini-sling versus a mid-urethral sling (Contasure-KIM®): 60-month follow-up results.

OBJECTIVES

Mid-urethral sling (MUS) insertion is the gold standard approach to treat stress urinary incontinence (SUI) and adaptable single-incision mini-slings (SIMSs) aim to reduce complications. A previous study of our team has found that SIMSs were comparable to transobturator slings in cure rates after 24 months of follow-up. This study aims to compare the rates of cure, complications and re-intervention of both slings over a long-term follow-up of 5 years.

STUDY

DESIGN

In this prospective trial, 179 women with SUI were randomly assigned to groups. A single surgeon performed all surgeries, and a blinded surgeon conducted 60-month follow-up exams. Objective and subjective cure was defined as a negative cough-stress test, and the absence of SUI based on ICIQ-SF, particularly. Failure was defined as the need for reoperation.

RESULTS

The 5-year subjective cure rates were comparable between TOT (75.0 %) and SIMS (65.8 %) groups (p = 0.281). Both groups exhibited decreased subjective cure rates from 24 to 60 months (p = 0.044 for TOT, p = 0.001 for SIMS). Mesh complication rates over 24 months were similar in TOT (7.9 %) and SIMS (6.8 %) groups (p = 0.528). Objective cure rates at 60 months were similar for both TOT (78.9 %) and SIMS (69.9 %) groups (p = 0.139). Reintervention for SUI was not significantly different between TOT (6.6 %) and SIMS (12.3 %) at 60 months (p = 0.098).

CONCLUSION

Single-incision needleless mini-slings showed similar cure rates to trans-obturator mid-urethral slings in 60-month follow-up. However, the objective cure rates decreased significantly from 24 to 60 months in the SIMS group (89.9 % to 69.9 %) compared to the TOT group (85.4 % to 78.9 %) (p = 0.002).