8-week home biofeedback system equivalent to 16-week for fecal incontinence in women

This single-blind, equivalence randomized clinical trial enrolled 38 women with fecal incontinence (FI), with 36 (18 per arm) providing complete data. Participants had a mean age of 62.4 years, and 97.3% were non-Hispanic White. The study compared an 8-week duration versus a 16-week duration of the same home-based digital therapeutic pelvic health system, which included biofeedback and optional remote health coaching with twice-daily exercises. The primary outcome was change in FI severity measured by the Vaizey score from baseline to 16 weeks.

Both treatment durations led to significant improvement in FI severity over time. The 8-week group had a mean score change of -4.7 (±5.1), and the 16-week group had a change of -4.8 (±4.5). The between-group difference was not statistically significant (P = 0.918), indicating equivalence. The improvements in both groups met the threshold for the minimal clinically important difference for the Vaizey score.

Safety and tolerability data were not reported. The study has several key limitations, including a small sample size (targeted 15 per arm, achieved 18 per arm), limited demographic diversity (predominantly non-Hispanic White women), and a follow-up period limited to 16 weeks. Funding sources and conflicts of interest were not reported.

For practice, this preliminary evidence suggests that an 8-week home-based biofeedback program may be as effective as a 16-week program for improving FI symptoms in the short term among a specific patient population. However, clinicians should interpret these results cautiously due to the small study size and lack of generalizability. The findings highlight a potential avenue for more efficient treatment delivery but require validation in larger, more diverse trials with longer follow-up.