Home versus office biofeedback therapy for dyssynergic defecation: parallel ARM randomized controlled trial
Abstract
Background: Office-based biofeedback therapy (OB) is efficacious for constipation with dyssynergic defecation (DD). However, it requires skilled staff, multiple visits and only available in selected centers. Whether home-based biofeedback therapy (HB) is also effective is not known. Methods: In a randomized controlled trial, patients with DD (Rome III) received either OB or HB. OB comprised of therapist-guided six biweekly sessions of pelvic floor training. HB comprised of self-training at home, 20 minutes, twice a day, after self-inserting a probe attached to a display box that provided individual, performance-specific, visual feedback. Anorectal physiology and daily symptom diary were assessed and compared. Subjects with normalization of dyssynergic defecation and ≥1 increase in number of complete spontaneous bowel movements (CSBM)/week at 3 months were considered responders. Cost outcomes were assessed using hospital billing records and questionnaires. ITT non-inferiority analyses and per protocol analyses were performed using the one-sided t-test with a margin (bound) added to the null value. Clinical trials.gov no NCT03202771. Results: 100 subjects (96 F) participated, 83 completed [Home = 38/50, office= 45/50]. Thirty-four (68%) patients were responders in HB and 35/50 (70%) in OB. The number of CSBM/week, dyssynergia pattern, balloon expulsion time, digital maneuver use and bowel satisfaction improved significantly (p<0.0001) from baseline with both treatments. The…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 100 participants or records.
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