| NCT ID | NCT07705542 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hull University Teaching Hospitals NHS Trust |
| Condition | Constipation |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2026-05-13 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2026-05-13 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * dyssynergia, constipation, obstructive defecation Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07705542 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Constipation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07705542 currently recruiting?
Yes, NCT07705542 is actively recruiting participants. Contact the research team at john.gallagher6@nhs.net for enrollment information.
Where is the NCT07705542 trial being conducted?
This trial is being conducted at Hull, United Kingdom.
Who is sponsoring the NCT07705542 clinical trial?
NCT07705542 is sponsored by Hull University Teaching Hospitals NHS Trust. The trial plans to enroll 10 participants.