RecruitingNAINTERVENTIONAL

Balloon Inflation in Biofeedback

This study is for people who suffer from ongoing constipation, especially when their bowel muscles don't coordinate correctly (called 'dyssynergia'). The best treatment for this is called biofeedback therapy, which teaches you how to use your tummy and bottom muscles when going to the toilet. Normally, a small balloon used in this therapy is kept flat. However, some doctors think filling the balloon a little could make it feel more like having to poo naturally, potentially helping people learn faster. This research aims to find out if using this slightly inflated balloon during biofeedback therapy is better at helping people control their muscles and understand the process compared to the standard flat balloon method. We want to see if this change can make biofeedback therapy even more effective.

At a glance

Status

Recruiting

Phase

Sponsor

Hull University Teaching Hospitals NHS Trust

Enrolment target

Start

13 May 2026

Estimated completion

01 Jul 2026

Constipation Chronic Constipation Dyssynergia Anismus

What is this study about?

If you have ongoing constipation, especially where your body's muscles don't work together properly when you try to have a bowel movement, you'll know how frustrating it can be. This problem is quite common and can really affect your day-to-day life. The good news is there's a treatment called biofeedback therapy (BFT), which is considered the best non-surgical way to help.

Biofeedback therapy teaches you how to coordinate your stomach and bottom muscles so you can have a bowel movement more easily. During this therapy, a small, soft balloon is gently placed inside your bottom. Usually, this balloon is kept flat. However, some doctors believe that if the balloon is slightly inflated, it might give you a more natural feeling of needing to go to the toilet, which could help you learn the muscle coordination more effectively.

This study wants to find out if this idea is true. We're testing whether doing biofeedback therapy with a slightly inflated balloon helps people learn to control their muscles better and understand the process more clearly than if the balloon stays flat. We hope this research will show us a better way to do biofeedback therapy, making it even more helpful for people with ongoing constipation.

Key takeaways

This study explores a new way to make biofeedback therapy for constipation more effective.
It focuses on people with ongoing constipation where muscles don't coordinate correctly.
Participants will undergo biofeedback therapy, either with a flat or slightly inflated balloon.
The goal is to see if an inflated balloon helps people learn muscle control better.
It aims to improve treatment options for chronic constipation.
You won't be given any new medications as part of the study.

Who may be eligible?

This study is designed for adults aged 18 and over who experience ongoing constipation because their muscles aren't working together properly when they try to have a bowel movement. This condition is sometimes called dyssynergia or obstructive defecation.

However, some people won't be able to join. For example, if you have any swelling or irritation in your bottom due to conditions like solitary rectal ulcer syndrome, or if your bottom area has changed significantly due to problems like a large rectocele, rectal prolapse, or intussusception. Also, if you've had major surgery on your bottom recently, you won't be able to take part.

We also can't include people with certain health conditions that might make the tests unsafe or difficult to tolerate. This includes recent bottom surgery (in the last 6 weeks), active infections in the bottom area, severe anal pain, bleeding piles (thrombosed haemorrhoids), or existing inflammatory gut problems like Coeliac disease or Crohn's disease.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you experience ongoing constipation because your muscles don't work together properly?
Do you have any significant inflammation, swelling, or major changes to the anatomy of your bottom area (e.g., large rectocele or prolapse)? (If yes, you likely can't join)
Have you had major surgery on your bottom in the last 6 weeks, or do you have any active infections or severe pain in that area? (If yes, you likely can't join)
Do you have inflammatory gut conditions like Coeliac or Crohn's disease? (If yes, you likely can't join)

Answer every question to see your result.

What does participation involve?

If you join this study, you won't need to take any new medicines. Your involvement will focus on special exercise sessions called biofeedback therapy. During these sessions, a small, soft balloon will be gently placed inside your bottom. Depending on which group you're in, this balloon will either be kept flat or slightly inflated to a comfortable level that mimics the feeling of needing to have a bowel movement.

You will learn and practice exercises to help you coordinate your muscles for easier bowel movements. We will use special equipment to measure how your muscles are working. The total duration of your participation will involve a few visits over a period, and we will explain the specific schedule and number of sessions needed during the consent process.

Potential risks and benefits

Participating in this study might offer you the benefit of potentially improved biofeedback therapy for your constipation. You might learn to control your muscles better, which could make going to the toilet easier and improve your quality of life. The main risks are generally mild discomfort from the balloon or the procedures, similar to what you might experience during standard tests for constipation. We will ensure your comfort throughout. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Hull University Teaching Hospitals
Verified postcode
Hull, United Kingdom· Recruiting

Common questions

What is 'biofeedback therapy'?

It's a special exercise programme that teaches you how to use your tummy and bottom muscles properly to have a bowel movement more easily.

What is 'dyssynergia'?

It means your muscles in your bottom area aren't working together in the right way when you try to pass a stool, making it difficult.

Will I have to take new medicines in this study?

No, this study is about improving a physical therapy, not testing new medicines. You won't be given any new medications for the trial.

Is the balloon uncomfortable?

The balloon is small and soft, and we will ensure it's placed gently. If you're in the group with the inflated balloon, it will only be filled to a comfortable level that feels like needing to go to the toilet.

How long will I be in the study?

Your participation will involve a few visits over a period, to complete the therapy sessions and assessments. The exact duration will be explained before you join.

How to find out more

John Gallagher, Clinical Scientist

john.gallagher6@nhs.net 01482624036 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.