RecruitingNAINTERVENTIONAL

Sacral Neuromodulation as Treatment for Chronic Constipation

This UK study is exploring a new treatment called low level laser therapy for people who suffer from severe, long-term constipation that hasn't improved with other usual treatments. The main goal is to see if this laser therapy can genuinely help these patients and if it's safe to use. Researchers want to understand if it could offer a new option for people whose colon and bowel muscles aren't working together properly. This is an early-stage study, meaning it doesn't compare the treatment to a dummy treatment, but aims to find out if it has any positive effects at all. Participants will receive laser therapy over three weeks, and then their symptoms and quality of life will be checked several weeks later.

At a glance

Status

Recruiting

Phase

Sponsor

McMaster University

Enrolment target

Start

08 Sep 2019

Estimated completion

01 Feb 2027

Chronic Constipation

What is this study about?

This study is investigating a new way to help people in the UK who have severe, long-term constipation. This isn't just everyday constipation; it's for people who have tried other standard treatments without success. The researchers are looking at a treatment called low level laser therapy. This therapy uses a special laser device on the skin to see if it can improve how the digestive system works.

The main idea behind this research is to find out if this type of laser therapy can actually make a difference for patients whose bowel and pelvic floor muscles aren't coordinating properly. Doctors can tell if this is happening through a special test called High-Resolution Colonic Manometry. This study is an early step, often called a 'proof of concept' study, which means they are simply trying to see if the treatment has any positive effects at all before comparing it to other treatments or a placebo.

Patients who take part will receive eight sessions of the laser therapy over three weeks. After the treatment, researchers will check their progress at four weeks and again at twelve weeks. They’ll use questionnaires to see if symptoms have improved and if the patient's quality of life has gotten better. They will also do physical tests to see if the colon and pelvic floor are working more effectively.

Key takeaways

New study explores laser therapy for severe constipation.
Aimed at those who haven't found relief from other treatments.
Involves 8 laser sessions over 3 weeks.
Checks if a person's bowel muscles are not coordinating properly.
Not a comparison study; aims to see if treatment works at all.
Follow-up assessments at 4 and 12 weeks after treatment.

Who may be eligible?

To be considered for this study, you must be a patient in the UK who has severe, ongoing constipation that hasn't improved with current treatments. You would also need to have had a specific test called 'High-Resolution Colonic Manometry' that showed your colon movement and bowel control aren't working together as they should. You should be between 6 and 70 years old.

There are several reasons why you might not be able to join the study. This includes if you are pregnant, have cancer in the area where the laser treatment would be, or have active bleeding or a blood clot in that area. You also can't participate if you have tattoos in the treatment area, are sensitive to light, or are currently taking certain pain relievers (like ibuprofen or aspirin) or steroids.

The study is open to both men and women who meet the other criteria.

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.

Do I have severe, long-term constipation that hasn't improved with other treatments?
Have I had a High-Resolution Colonic Manometry test showing abnormal bowel muscle coordination?
Am I between 6 and 70 years old?
Am I pregnant, or do I have cancer, active bleeding, or a blood clot in the treatment area?
Do I have tattoos in the treatment area, or am I sensitive to light?
Am I currently taking NSAIDS (like ibuprofen) or steroid medications?

Answer every question to see your result.

What does participation involve?

If you join this study, you will have a special test called High-Resolution Colonic Manometry if you haven't already had one. This test checks how your colon and back passage are working together. If you're suitable, you'll then have eight sessions of low level laser therapy over a three-week period. These sessions involve having a special laser applied to the skin over the area being treated.

After the treatment, you won't need to take any new medications as part of the study. Your symptoms will be checked at two points: four weeks and twelve weeks after your treatment finishes. This will involve filling out questionnaires about your symptoms and how your daily life is affected. You will also have follow-up physical assessments of your colon and pelvic floor function. The total duration of your active participation in the study from the start of treatment to your final assessment will be about 15 weeks.

Potential risks and benefits

This study is an early exploration of low level laser therapy for severe constipation, and it's not guaranteed to help everyone. Potential benefits might include an improvement in your constipation symptoms and a better quality of life if the treatment proves effective. However, there's always a chance that the treatment might not work for you, or it could potentially cause mild side effects like temporary skin redness in the treated area, though no serious risks are expected with low level laser therapy. Remember, you have the right to withdraw from the study at any time without giving a reason, and it will not affect your usual medical care.

Locations (1)

McMaster University
Verified postcode
Hamilton, Canada· Recruiting

Common questions

What is 'low level laser therapy'?

It's a treatment that uses special low-power lasers on the skin. It's thought to help relieve pain and promote healing without causing heat or damage.

How many treatment sessions would I have?

You would have a total of eight laser therapy sessions spread out over three weeks.

Will I have to stop my current constipation medicines?

The study information doesn't say you need to stop current medicines, but you should discuss all your medications with the study doctor.

What does 'High-Resolution Colonic Manometry' involve?

It's a test where a thin tube is passed into your bowel to measure the pressure and movements of your colon and rectum, helping doctors understand how they're working.

Could I get a dummy treatment instead of the real laser?

No, this study does not include a dummy treatment (a placebo). Everyone in the study will receive the active low level laser therapy.

How to find out more

Jihong Chen, MD PhD

chen338@mcmaster.ca 2263439909 Official trial record

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