Single-incision Mini-slings Versus Retropubic Tension-free Vaginal Tapes: A Multicenter Clinical Trial

Abstract

Study ObjectiveTo compare single-incision mini-slings (SIMSs) and retropubic tension-free vaginal tape (r-TVT) in terms of the long-term efficacy and safety for the treatment of female stress (SUI) or mixed urinary incontinence (MUI). DesignProspective multicenter cohort trial (registration number NCT00751088) (Canadian Task Force II). SettingsDepartment of Obstetrics and Gynecology, Italy. PatientsTwo hundred-forty women with SUI/MUI. InterventionsSIMS or r-TVT. Measurements and Main ResultsThe operative time and the use of analgesic tablets were significantly (p < .001) higher and lower, respectively, in the r-TVT group versus the SIMS group. After 24 months of follow-up, no difference between the study arms was observed in terms of the complication rate (30/120 [25%] vs 19/120 [15.8%] for the r-TVT and SIMS arms, respectively; relative risk = 1.58; 95% confidence interval, 0.94–2.65; p = .083), whereas the subjective cure rate was significantly lower in the SIMS arm than in the r-TVT arm (57/103 [55.3%] vs 89/106 [84.0%] for the r-TVT and SIMS arms, respectively; relative risk = 0.66; 95% confidence interval, 0.54–0.80]; p < .001). The proportion of retreated patients for SUI/MUI was significantly higher in the SIMS arm than in the r-TVT arm (37/103 [34.9%] vs 12/106 [11.3%] for SIMS and r-TVT arm, respectively; p < .001). ConclusionSIMS has no advantage in terms of safety over r-TVT and was found to be less effective than r-TVT. Thus, its use in the clinical practice should be questioned.