Home-based versus office-based biofeedback therapy for constipation with dyssynergic defecation: a randomised controlled trial.
Level 2 - randomized trial
Individual randomized controlled non-inferiority trial
PubMed 30236904 · doi:10.1016/S2468-1253(18)30266-8
What was done
Adult outpatients (n = 100, aged 18–80) with Rome III functional constipation and dyssynergic defecation unresponsive to routine management were randomly assigned 1:1 to office-based biofeedback (6 therapist-guided pelvic floor sessions over 3 months) or home-based biofeedback (20-minute self-training sessions twice daily using a self-inserted probe and handheld monitor). Primary outcomes were presence of dyssynergic defecation pattern, balloon expulsion time, weekly complete spontaneous bowel movements (CSBMs), and bowel satisfaction, evaluated for non-inferiority via intention-to-treat and per-protocol analyses.
What was found
Eighty-three patients completed training (38/50 [76%] home vs 45/50 [90%] office). Responder rates (normalization of dyssynergia plus increased weekly CSBMs) were 68% (34/50) in the home group and 70% (35/50) in the office group. All primary outcomes improved significantly from baseline in both arms (all p < 0.0001). Home biofeedback was non-inferior to office biofeedback for CSBMs, satisfaction, and balloon expulsion time in intention-to-treat and per-protocol analyses, and for dyssynergia in the per-protocol analysis. No adverse events occurred. Median cost was significantly lower for home therapy (US$1,081.70 vs $1,942.50, p = 0.009).
Why it matters
Home-based biofeedback achieves clinical and physiological outcomes comparable to office-based training at significantly lower cost, offering a scalable treatment option where specialized therapist access is limited.
Limits
Single-center trial with a modest sample size. Completion rate was lower in the home arm (76% vs 90%), dyssynergia resolution met non-inferiority only in per-protocol analysis, and the responder definition was post hoc. Long-term durability beyond 3 months was not reported.
Cited by
- supports Biofeedback physical therapy for pelvic floor dyssynergia is approximately 80% effective after two to three months of treatment.