Application of single-incision mini-sling surgery versus standard mid-urethral sling surgery in female stress urinary incontinence: a systematic review and meta-analysis of randomized controlled trials

Objective: Suburethral mid-urethral sling (SMUS) is considered the gold standard for the treatment of female stress urinary incontinence (SUI). In recent years, the vaginal single-incision mini-sling (SIMS) has emerged as a new approach for treating SUI. However, the efficacy and safety of SIMS require further experimental validation. This study aimed to evaluate the efficacy and safety of the vaginal SIMS compared to SMUS in the treatment of female SUI. Data sources: This study incorporated studies published from January 2007 to May 2024, encompassing our complete literature search and selection timeline. Following the inclusion criteria for systematic reviews and meta-analyses, we performed a meta-analysis of all randomized controlled trials (RCTs) comparing the vaginal SIMS and SMUS. Study eligibility criteria: All published RCTs involving women with SUI receiving SIMS or SMUS were eligible for inclusion, with no exclusion criteria based on language, type of SIMS/SMUS devices, or publication status. Study appraisal and synthesis methods: Data were analyzed using Review Manager 5.3, with primary outcomes being patient-reported and objective cure rates. Secondary outcomes included operative time, length of hospital stay, postoperative day one pain scores, quality of life assessments, and certain safety-related surgical indicators. Results: A total of 24 RCTs were included, comprising 3687 women, of whom 328 were lost to follow-up, with a mean follow-up duration of 13.42 months. SIMS showed a slight superiority over SMUS in terms of objective cure rates (risk ratio [RR]: 0.93; 95% CI [confidence interval], [0.85, 0.98]). Compared to SMUS, SIMS was significantly associated with reduced operative time (mean difference [MD]: −6.52; 95% CI, [−9.47, −3.57]), shorter hospital stays (MD: −0.23; 95% CI, [−0.42, −0.05]), lower pain scores on postoperative day one (MD: −2.28; 95% CI, [−3.21, −1.36]), lower incidence of organ injury (RR: 0.30; 95% CI, [0.13, 0.69]), less groin pain (RR: 0.24; 95% CI, [0.08, 0.73]) and less postoperative bleeding (MD: −24.27 ml; 95% CI, [−32.32, −16.23]). However, there were no statistically significant differences between SIMS and SMUS regarding patient-reported cure rates, quality of life, urinary difficulties, sling erosion, dyspareunia, reoperation, new-onset urgency incontinence, postoperative urinary tract infections, or other postoperative complications. Conclusions: SIMS is not inferior to SMUS in terms of patient-reported cure rates, objective cure rates, quality of life, and postoperative complications in treating female SUI. Additionally, SIMS demonstrates advantages over SMUS in terms of operative time, length of hospital stay, postoperative pain, incidence of organ injury, and amount of postoperative bleeding.