Abstract
To evaluate the safety and efficacy of surgeon-tailored polypropylene mesh (STM) through a needle-less single incision mini-slings (SIMS) vs. standard trans-obturator tape (TOT) in the treatment of female stress urinary incontinence (SUI). Methods: We conducted an open-label randomized controlled trial that included women with SUI. Eligible women were randomized in a 1:1 ratio to receive either standard TOT or SIMS techniques. All procedures were performed using a surgeon-tailored polypropylene mesh and monofilament tape. Results: A total of 60 women were included. The mean operative time was significantly longer in the standard TOT group. The mean bleeding rate was significantly higher in the standard TOT group (87.6 ± 10.6 cc) compared to the SIMS group (60.0 ± 8.1 cc). There was no urethral injury in both groups. Transient thigh pain occurs in 12 cases (40 %) of the standard TOT and no cases in the SIMS group (p < 0.001). After three months, there was no significant statistical difference between the result of the two groups as regard to cure or improvement rate. No failed cases were reported in both groups (p = 0.64). Likewise, there was no significant difference between the two groups regarding patients' satisfaction rate. Conclusions: SIMS was not inferior to standard TOT. STM SIMS is a mini-invasive, relatively safe, reproducible, easy to perform in a short time, with excellent patient tolerability and minimal pain, allowing early return to work and economically effective surgical procedure for the treatment of female stress urinary incontinence.