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NCT Number: NCT07705542

Balloon Inflation in Biofeedback

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hull University Teaching Hospitals

Hull, HU16 5JQ, United Kingdom

Location status: Recruiting

Location contact

Leanne Cox

CONTACT

[email protected]

07731098066

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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

No intervention

Other

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

Primary outcomes

  1. Physiological improvement

    Time frame: During a single study visit; baseline measurements (balloon deflated) and intervention measurements (balloon inflated to the participant's desire-to-defecate volume) are obtained sequentially during the same HRAM examination.

    The primary outcome measure for this study is the change in anorectal pressure gradient (the difference between rectal and anal canal pressures) recorded during the push manoeuvre on high-resolution anorectal manometry (HRAM). This measurement reflects how effectively the rectal and anal muscles work together to open the bowels - known as defecatory coordination.

    The study will compare each participant's average pressure gradient when performing push manoeuvres:

    • with the balloon deflated (standard practice), and
    • with the balloon inflated to the level that gives the natural sensation of needing to open the bowels.

    An improvement in the pressure gradient (i.e. a higher rectal pressure relative to anal pressure) will indicate better defecatory performance.

Secondary outcomes

  1. Patient experience

    Time frame: During the study visit; immediately following completion of both balloon conditions during the HRAM biofeedback session.

    The secondary outcome measures for this study focus on participants' experiences and perceptions during the biofeedback session, as well as the consistency of their physiological responses.

    • Patient-perceived ease and naturalness of the push manoeuvre
    • Participants will rate how easy or natural it felt to perform the push manoeuvre under each condition - with the balloon inflated and deflated.
    • Responses will be collected immediately after the procedure using a short, structured questionnaire (e.g. Likert-type scale).
    • This will help determine which condition feels more realistic and comfortable to participants.
    • Reproducibility of defecatory pressure patterns
    • The consistency of push manoeuvre pressure profiles will be compared between the inflated and deflated balloon conditions.
    • This will assess whether balloon inflation improves the reliability of muscle coordination during repeated attempts.

Study contacts

Contact information is provided by the study sponsor or research team.

John Gallagher, Clinical Scientist

CONTACT

[email protected]

01482624036

Sponsors and collaborators

Lead sponsor

Hull University Teaching Hospitals NHS Trust

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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