Importance Access to biofeedback, a first-line treatment for fecal incontinence (FI), is limited. Objective The objective of this study was to evaluate whether an 8-week duration of a home-based digital therapeutic pelvic health system to treat FI in women is equivalent to a 16-week duration. Study Design We conducted a single-blind, randomized, equivalence trial in women with FI. Participants were randomized to 8 or 16 weeks of twice-daily exercises using the system and could opt to participate in remote health coaching. The primary outcome was the change in FI severity as measured by the Vaizey score from baseline to 16 weeks. Our target sample size was 15 participants per arm. Paired t test, χ 2 test, and McNemar-Bowker test compared differences over time and between groups. Results Among 38 women enrolled, 36 (18 per arm) provided complete data. All received allocated treatment, with a mean adherence of 75.2%. Most participants identified as non-Hispanic White (97.3%), with a mean age of 62.4 ± 15.4 years and a mean body mass index 29.5 ± 8.9. Baseline FI severity was high and improved significantly over time in both groups. Treatment duration of 8 weeks was equivalent to 16 weeks with changes in Vaizey scores that reached the minimal clinically important difference in both groups (-4.7 ± 5.1 vs -4.8 ± 4.5, P = 0.918). Conclusions FI outcomes improved significantly with a home-based pelvic health system with biofeedback and remote health coaching used for either 8 or 16 weeks, without significant differences between groups.
Patel et al. (Fri,) studied this question.