RecruitingNot ApplicableNCT07705542

Balloon Inflation in Biofeedback

Analysing the Impact of Balloon Inflated vs Balloon Deflated Push Manoeuvres in Chronically Constipated Patients During Biofeedback Therapy


Sponsor

Hull University Teaching Hospitals NHS Trust

Enrollment

10 participants

Start Date

May 13, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria1

  • dyssynergia, constipation, obstructive defecation

Exclusion Criteria6

  • 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

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Interventions

OTHERInflating anorectal catheter balloon to defecatory desired volume during push manoeuvres in biofeedback therapy.

This study specifically uses the patient's own defecatory desire volume during biofeedback therapy to help improve physiological push technique.

OTHERNo intervention

The patient will do the manoeuvres in the usual way during our clinic appointments which is with the balloon deflated.


Locations(1)

Hull University Teaching Hospitals

Hull, United Kingdom

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NCT07705542


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