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Balloon Inflation in Biofeedback

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Trial completed Show 6 more changesShow less
    • Final enrollment: 8 participants (planned 10)
    • Primary and study completion dates changed from estimate of Jul 2026 to Jul 6, 2026
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised
    • Publications: details revised at 14 of 14 entries
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
(from sponsor)		 Constipation, Chronic Constipation, Dyssynergia, Anismus
Related terms Ataxia, Constipation
Enrollment 8 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov