A 12-Month Clinical Durability of Effectiveness and Safety Evaluation of a Vaginal Bowel Control System for the Nonsurgical Treatment of Fecal Incontinence

The vaginal bowel control system achieved a 72.6% success rate (50% or greater reduction in FI episodes) at 3 months in the ITT population, with success rates sustained at 6 and 12 months and reaching

Effect: improvement; 72.6% success rate (ITT) at 3 months; CI: 95% CI, 61%-82%

The VBC system produced significant improvement in all Fecal Incontinence Quality of Life subscales and St Mark's score, meeting minimally clinically important differences for both instruments at 3, 6

Effect: improvement; Significant improvement in all FIQOL subscales and St Mark's score meeting minimally important differences

Patient satisfaction with the VBC system was 91.7%, 89.7%, and 94.4% at 3, 6, and 12 months respectively, and 77-80% reported symptoms very much or much better on the PGI-I across all time points.

Effect: improvement; 94.4% satisfaction at 12 months

The most common adverse event was vaginal wall injury, with most adverse events (90/134, 67%) occurring during the fitting period rather than the treatment period. No serious device-related adverse ev

Effect: adverse; 28/73 (38%) experienced mild or moderate device-related AEs during treatment period

Of 137 subjects who entered the fitting assessment, 62% achieved a successful fit, an improvement from the 54.5% in the initial study, possibly related to the provider learning curve.

Effect: improvement; 62.0% (85/137) achieved successful fit