Midurethral slings are effective for stress urinary incontinence (SUI) but are associated with mesh-related complications and long-term decline in efficacy. Vaginal arcocolposuspension (VACS) is a mesh-free native tissue repair technique designed to restore urethral support via fixation to the arcus tendineus fascia pelvis. We hypothesized that VACS provides objective continence outcomes comparable to transobturator midurethral sling (TOT) while avoiding implant-related risks and potentially improving patient-reported outcomes.

This was a prospective randomized open-label parallel-group clinical trial including women with urodynamically confirmed pure SUI. Participants were randomized 1:1 to VACS or TOT. Co-primary outcomes were objective continence assessed by one-hour pad test and provoked cough stress test at 12 months. Secondary outcomes included validated questionnaires (UDI-6, IIQ-7, I-QOL, OAB-V8, FSFI) and adverse events. Extended follow-up was performed at approximately 43 months. Sample size was calculated to detect clinically meaningful differences in objective continence with 80% power and α=0.05, requiring 60 participants. Analyses included intention-to-treat principles and longitudinal comparisons.

A total of 60 participants were randomized; 57 completed 12-month follow-up and 36 were available at mid-term follow-up (~43 months). Objective dryness rates were comparable between groups at 12 months (VACS 88.9% vs TOT 77.8%) and at extended follow-up (64.7% vs 61.1%), with no statistically significant differences. Both groups demonstrated a decline in continence over time consistent with known long-term patterns.

Patient-reported outcomes improved substantially in both groups. At extended follow-up, UDI-6 scores were significantly lower in the VACS group (4.5 vs 8.0), and I-QOL scores were significantly higher (94.3 vs 74.4), indicating lower symptom burden and better quality of life. Change-from-baseline analyses showed similar magnitudes of improvement between groups.

No mesh-related complications occurred in the VACS group. In contrast, two cases of delayed mesh extrusion were observed in the TOT group during extended follow-up. Sexual function remained stable and comparable between groups.

VACS achieves objective continence outcomes within the established efficacy range of midurethral sling procedures while avoiding synthetic material use. The absence of mesh-related complications and favorable patient-reported outcomes suggest a potential clinical advantage of native tissue repair. The comparable change scores indicate similar treatment effects, while absolute differences may reflect residual symptom burden differences over time.

Vaginal arcocolposuspension is a viable mesh-free alternative for the surgical treatment of SUI, providing comparable objective outcomes to TOT with improved patient-reported outcomes and no implant-related complications at mid-term follow-up. These findings support further evaluation of native tissue approaches in larger randomized trials.

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