Balloon Inflation in Biofeedback

July 13, 2026 updated by: Hull University Teaching Hospitals NHS Trust

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Hull, United Kingdom, HU16 5JQ
        • Recruiting
        • Hull University Teaching Hospitals
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Balloon deflated on push manoeuvre during biofeedback therapy
Other: No intervention
The patient will do the manoeuvres in the usual way during our clinic appointments which is with the balloon deflated.
Active Comparator: Balloon inflated to defecatory desire volume on push manoeuvre during biofeedback therapy
Other: Inflating 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

  1. 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.

  2. 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.
During the study visit; immediately following completion of both balloon conditions during the HRAM biofeedback session.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hull University Teaching Hospitals NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

June 22, 2026

First Submitted That Met QC Criteria

July 13, 2026

First Posted (Actual)

July 15, 2026

Study Record Updates

Last Update Posted (Actual)

July 15, 2026

Last Update Submitted That Met QC Criteria

July 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 367053

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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