Clinical Trial

Balloon Inflation in Biofeedback

Recruiting
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Summary
Chronic constipation, particularly due to dyssynergic defecation, is common and impacts quality of life. Biofeedback therapy (BFT) is the most effective conservative treatment, teaching patients to coordinate abdominal and anal muscles during defecation. In standard practice, the rectal balloon used in high-resolution anorectal manometry (HRAM) and biofeedback is left deflated, though some centres inflate it to simulate a more natural urge to defecate. However, the efficacy of this modification has not been validated. This study aims to determine whether performing BFT with the balloon inflated to a patient's defecatory desire volume enhances physiological coordination and patient understanding compared to the standard deflated approach.
Trial Details
NCT Number NCT07705542
Lead Sponsor Hull University Teaching Hospitals NHS Trust
Conditions Constipation, Chronic Constipation, Dyssynergia, Anismus
Enrollment 10 participants
Start Date 2026-05-13
Primary Completion 2026-07 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2026-07-15