RecruitingNAINTERVENTIONAL

Sacral Neuromodulation as Treatment for Fecal Incontinence

This study investigates a new treatment called low-level laser therapy (LLLT) for people experiencing severe bowel incontinence that hasn't responded to other treatments. The main goal is to see if this laser therapy can improve symptoms and how people feel about their quality of life. Participants will have 8 laser sessions over three weeks. Researchers will then check progress at 4 and 12 weeks after starting the treatment. There won't be a control group receiving a fake treatment, as this is a first look at whether the treatment shows promise. Participants aged 6 to 80, male or female, may be able to join, as long as they don't have certain other health conditions.

At a glance

Status

Recruiting

Phase

Sponsor

McMaster University

Enrolment target

Start

08 Sep 2019

Estimated completion

01 Feb 2027

Fecal Incontinence

What is this study about?

Bowel incontinence is when you have trouble controlling your bowel movements, which can be very upsetting and affect your daily life. This study is exploring a new way to help people with severe bowel incontinence that hasn't gotten better with other treatments. The new approach uses something called low-level laser therapy, which involves applying a laser to the affected area. The study aims to find out if this therapy can make a real difference in reducing symptoms and improving how people feel about their lives.

Think of this study as an early exploration. The researchers want to see if this laser treatment is helpful without comparing it to a 'dummy' treatment (a placebo). It's sometimes called a 'proof of concept' study, meaning they are trying to see if the idea of using this laser therapy for bowel incontinence has any merit before moving on to larger studies.

The main goals are to see if the laser therapy can improve your bowel control and overall well-being. They will measure this by asking you to fill out questionnaires about your symptoms and how your quality of life has changed. They will also do some physical checks to see if your pelvic floor muscles, which are important for bowel control, are working better.

Key takeaways

This study is testing a new laser treatment for severe bowel incontinence.
It involves 8 laser sessions over three weeks, followed by check-ups.
The goal is to see if the laser can improve symptoms and quality of life.
There is no 'fake' treatment group; everyone gets the laser therapy.
Both men and women, aged 6 to 80, may be able to participate.

Who may be eligible?

This study is looking for people who are experiencing bowel incontinence. Both men and women between the ages of 6 and 80 can potentially take part.

However, there are some reasons why you wouldn't be able to join. For example, if you are pregnant, have any known cancers in the area where the laser treatment would be applied, or if you have any active bleeding or a recent deep vein clot in that area, you wouldn't be eligible. Also, if you have tattoos in the treatment area, are very sensitive to light, or are currently taking steroid medications, you wouldn't be able to participate. These rules are in place to keep everyone safe during the study.

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 bowel incontinence?
Am I between 6 and 80 years old?
Am I pregnant or could I be?
Do I have any cancer or active bleeding in the treatment area?
Do I have tattoos in the area where the laser would be applied?
Am I sensitive to light or taking steroid medications?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, it will involve a few visits over a short period. You'll receive the laser treatment over three weeks, with a total of 8 sessions. Each session will involve applying the low-level laser. After these treatments, the researchers will check in with you twice more. You'll have assessments at 4 weeks and again at 12 weeks after your treatment started. These assessments will include filling out questionnaires about your symptoms and how you're feeling, as well as some physical checks of your pelvic floor muscles. The total duration of your active participation, from the first treatment to the final follow-up, will be around 12 weeks.

Potential risks and benefits

Participating in this study might offer a potential benefit if the low-level laser therapy helps to improve your bowel incontinence symptoms and your quality of life. However, as this is a new approach being tested, there's no guarantee it will help everyone, and it's possible it may not work for you. While low-level laser therapy is generally considered safe, potential risks might include temporary discomfort or skin irritation in the treated area, or other unforeseen side effects. All possible risks will be explained to you in detail by the study team. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

McMaster University
Verified postcode
Hamilton, Canada· Recruiting

Common questions

What is bowel incontinence?

Bowel incontinence is when you have difficulty controlling your bowel movements.

What is low-level laser therapy?

It's a treatment that uses a special laser close to the skin. It's meant to help body tissues heal and function better.

Will I receive a fake treatment?

No, this study does not include a fake treatment (placebo). Everyone who participates will receive the active laser therapy.

How long will the study last for me?

Your active participation, including treatments and follow-up, will last about 12 weeks.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time without having to give a reason, and it won't affect your medical care.

How to find out more

Jihong Chen, MD PhD

chen338@mcmaster.ca 1-226-3439909 Official trial record

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