CompletedInterventional

A comparison of two medical devices that assess how people sense the need to empty their bowels

This study is looking at two different devices used to understand how people sense the need to empty their bowels. Many hospitals use an elastic balloon, but another less common device, called a rectal barostat, uses a non-elastic bag. This study wants to find out if both devices lead to the same diagnosis for conditions like constipation, leaking stool, or feeling the need to go to the toilet too often. By comparing the two, researchers hope to see if the newer barostat device gives a more accurate diagnosis, which could help more people get the right treatment for their bowel issues. It focuses on symptoms that can affect daily life.

At a glance

Status

Completed

Sponsor

Newcastle upon Tyne Hospitals NHS Foundation Trust

Enrolment target

Start

29 Apr 2024

Estimated completion

01 Jan 2026

Patients with bowel symptoms including symptoms of constipation or disorder of evacuation, faecal incontinence functional anorectal pain, faecal urgency and frequency of moving bowels, or a constant urge to move bowels

What is this study about?

When we need to empty our bowels, sensors in the lower part of our bowel (called the rectum) tell our brain what's happening. For some people, these sensors don't work properly – they might not feel anything, or they might feel too much. This can lead to uncomfortable problems like constipation, needing to go to the toilet urgently, or even accidentally leaking stool, all of which can really affect someone's quality of life.

Currently, many hospitals in the UK use a small, stretchy balloon placed inside the rectum to test these sensations. Patients are asked to report what they feel as the balloon inflates, and this helps doctors understand the problem and plan treatment. However, there's another device called a rectal barostat, which uses a non-stretchy bag. Because this bag doesn't stretch, it can also measure how much space there is in the rectum and how flexible its walls are. This study aims to see if undergoing tests with both the common elastic balloon and the newer barostat device will lead to the same diagnosis. If the barostat gives a different or more accurate diagnosis, it suggests that more hospitals might benefit from using it.

This research is important because getting an accurate diagnosis is the first step towards getting the right treatment. By comparing these two methods, the study hopes to improve how we diagnose and help people with bowel control problems, ultimately leading to better care and improved daily lives for many individuals.

Key takeaways

Compares two devices (elastic balloon and non-stretchy bag) to check bowel sensation.
Aims to improve diagnosis for common bowel problems like constipation or urgency.
Participation adds about 30 minutes to a standard hospital appointment.
Results of the new test will be added to your medical report.
Small risks, but steps are taken to keep you comfortable and safe.

Who may be eligible?

This study is looking for adults between 18 and 90 years old who are already coming to the hospital for tests because of bowel problems. These problems might include constipation, difficulty emptying your bowels, leaking stool, pain in the back passage, or frequently needing to go to the toilet or feeling a constant urge.

You would also need to have had another check-up of your lower bowel in the last two years, such as a colonoscopy or a digital rectal examination. It's important that participants can understand English, both spoken and written, to take part.

However, some people will not be able to join the study. This includes pregnant women, anyone who has had certain types of bowel surgery or radiotherapy to the pelvic area, or those with inflammatory bowel disease, or any history of certain cancers in the bowel or back passage. If you've had recent haemorrhoid treatment or have unexplained bleeding or weight loss without recent investigations, you also wouldn't be able to participate.

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 between 18 and 90 years old?
Do you experience bowel symptoms like constipation, leaking stool, or urgency?
Have you had a lower bowel check-up (e.g., colonoscopy) in the last two years?
Can you understand written and spoken English?
Have you *not* had recent bowel surgery, pelvic radiotherapy, or inflammatory bowel disease?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll already be coming for your usual bowel tests. During this same appointment, you would also have the rectal barostat test. This means you'll have the standard tests (which include an ultrasound and another sensitivity test using an elastic balloon) and then the additional barostat test. The barostat test is expected to add about 30 minutes to your appointment, but it's done at the same visit to save you an extra trip. After your appointment, you'll be offered a short questionnaire to fill out at reception before you leave. Once that's done, your involvement in the study is complete.

Potential risks and benefits

A potential benefit of joining this study is that the results from the additional barostat test will be included in your medical report. This means your doctor will have more information when planning your care. However, there are some small risks, similar to the standard tests. You might feel some discomfort or pain during the test, and there's a very small chance (less than 1 in 1000) of bleeding or a tiny tear in the rectum. The study team takes steps to minimise these risks, such as using lubrication and stopping the test if you feel too much discomfort. You are in control and can withdraw from the study at any point, and the test will be stopped immediately.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

The Royal Victoria Infirmary and Associated Hospitals NHS Trust
City only
Newcastle upon Tyne, England
University Hospital of North Durham Cdc
City only
Durham, England

Common questions

What is a rectal barostat test?

It's a test that uses a non-stretchy bag placed in your lower bowel (rectum) to measure how your body senses the need to empty your bowels and how flexible your bowel walls are.

Will this test be painful?

You might feel some discomfort during the test, similar to other bowel examinations. The team will use lubrication and can stop the test at any time if you're uncomfortable.

How long will the study add to my hospital visit?

The additional rectal barostat test will add about 30 minutes to your regular appointment. It will all be done during one hospital visit.

Who is funding this research?

The study is funded by Newcastle upon Tyne Hospitals NHS Foundation Trust in the UK.

Will I get to see the results of the barostat test?

Yes, the results of the rectal barostat test will be included in the report your doctor receives from your clinic appointment.

How to find out more

Natalie Page

natalie.page9@nhs.net +44 (0)191 282 4493 Official trial record

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