Balloon Inflation in Biofeedback
Recruiting now · Not applicable
Conditions studied: Constipation, Chronic Constipation, Dyssynergia, Anismus
In brief
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.
Key facts
- Study ID
- NCT07705542
- Run by
- Hull University Teaching Hospitals NHS Trust
- People needed
- 10
- Starts
- 2026-05-13
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2026-07-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- dyssynergia, constipation, obstructive defecation
You may not qualify if…
- Patients with anorectal inflammation due to conditions such as solitary rectal ulcer syndrome
- Patients with significantly altered anorectal anatomy due to abnormalities such as large rectocele, rectal prolapse or intussusception
- History of major anorectal surgery
- Unable to be investigated with HR-ARM due to contraindications such as recent anorectal surgery (<6 weeks), active anorectal infections, severe anal pain or fissures(?), thrombosed haemorrhoids, or inability to tolerate anorectal catheters
- Patients with pre-existing co-morbid inflammatory gastrointestinal conditions, including
- Coeliac and Crohn's disease
Where it is running
- Hull University Teaching Hospitals — Hull, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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