Prospective and randomized clinical trial comparing transobturator versus retropubic sling in terms of efficacy and safety

Abstract

Introduction and hypothesis: The midurethral sling is the most commonly performed surgical procedure for stress urinary incontinence (SUI). We compared the efficacy of transobturator tape (TOT) and retropubic (RP) slings by evaluating objective and subjective cure rates at 12 months postsurgery and evaluate the impact on quality of life (QoL) and record intra- and postoperative complications.

Methods: This was a randomized, controlled, prospective, clinical trial with analysis of noninferiority. The hypothesis was that the TOT sling is not inferior to the RP sling. A total of 92 women with SUI were selected and randomized into two groups: TOT and RP slings.

Results: Eighty-one patients maintained follow-up 12 months postoperatively. In the per-protocol analysis, the objective cure rates were 100% for the RP sling and 93% for the TOT sling (p = 0.029). The subjective cure rates were 92% for the RP sling and 90% for the TOT sling (p = 0.02). Because none of the upper limits of the confidence interval (CI) were above the noninferiority margin, noninferiority of the TOT sling could be concluded. In contrast, the intention-to-treat analysis could not show that the TOT sling was not inferior to the RP sling, because the upper limit of the CI surpassed the noninferiority margin. Postoperative complications were similar for both groups, except for higher urinary retention rates in the RP group. Regarding QoL, there was a significant improvement.

Conclusions: The cure rates of the per-protocol analysis showed the noninferiority of the TOT relative to the RP sling. The RP sling group exhibited higher urinary retention. Quality of life improved significantly in both groups.

Keywords: Midurethral sling; Noninferiority analysis; Quality of life; Retropubic sling; Stress urinary incontinence; Transobturator sling.