What side effects are associated with this type of intervention?

Common treatments for bowel incontinence include dietary changes, medications, pelvic floor exercises, and surgical interventions. Treatments similar to Low-Level Laser Therapy, such as electrical stimulation and biofeedback, aim to improve muscle function and reduce inflammation. Known side effects of these treatments can include discomfort during the procedure, temporary skin irritation, and, in rare cases, infection or worsening of symptoms. Overall, these treatments are generally well-tolerated, but patients should discuss potential risks with their healthcare provider.

What prior FDA approvals exist?

There are no specific FDA approvals for low-level laser therapy (LLLT) for the treatment of bowel incontinence. However, treatments that focus on similar mechanisms, such as stimulation of cellular function, reduction of inflammation, and promotion of tissue repair, include sacral neuromodulation and biofeedback therapy. Sacral neuromodulation involves electrical stimulation to improve bowel control, while biofeedback therapy helps patients strengthen their pelvic floor muscles. These treatments aim to enhance cellular function and tissue repair, indirectly addressing inflammation and improving continence.

What other types of research exist?

Promising novel alternatives to Low Level Laser Therapy for bowel incontinence include sacral neuromodulation, stem cell therapy, and hyperbaric oxygen therapy. These treatments aim to stimulate cellular function, reduce inflammation, and promote tissue repair.

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Device

Low Level Laser Therapy for Bowel Incontinence (LLLT-FI Trial)

N/A

Recruiting

Led By Jihong Chen, MD PhD

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with fecal incontinence

Must not have

Active bleeding in area of treatment

Known malignancies in the area of treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 and 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a special light therapy to help people who can't control their bowel movements and haven't been helped by other treatments. The therapy involves multiple sessions over a few weeks. Researchers will check if it improves symptoms and quality of life by looking at questionnaires and physical tests.

Who is the study for?

This trial is for individuals with severe fecal incontinence, which means they have trouble controlling their bowel movements. It's not open to pregnant people, those on steroids, anyone with active deep vein thrombosis or bleeding in the treatment area, light-sensitive patients, or if there are tattoos or known cancers where the therapy will be applied.

What is being tested?

The study is testing low level laser therapy (LLLT) to see if it helps patients with severe refractory fecal incontinence. There isn't a placebo group being compared against; this is an initial test of the concept to understand its effects.

What are the potential side effects?

Since LLLT doesn't involve drugs and uses low-intensity lasers, side effects might include local skin irritation at the site of application. However, specific side effect profiles will be studied as part of this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I experience loss of bowel control.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently experiencing bleeding in the area that needs treatment.

Select...

I have cancer in the area where treatment is planned.

Select...

I currently have a deep vein thrombosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 and 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 and 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in number of fecal incontinence episodes

Secondary study objectives

Change in Quality of Life

Change in anal sphincter tone

Change in increase of anal sphincter pressure during squeezing

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Incontinence and low level laser therapyExperimental Treatment1 Intervention

Intervention: Low level laser therapy (sacral neuromodulation or photobiomodulation) will be administered to patients with fecal incontinence

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Low level laser therapy (LLLT)

2021

N/A

~200

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for bowel incontinence include anal bulking agents, endoanal electrical stimulation with biofeedback, and low-level laser therapy. Anal bulking agents work by increasing the bulk of the anal canal, thereby improving sphincter function. Endoanal electrical stimulation with biofeedback helps strengthen the pelvic floor muscles and improve coordination. Low-level laser therapy stimulates cellular function, reduces inflammation, and promotes tissue repair. These mechanisms are crucial for bowel incontinence patients as they address the underlying issues of muscle weakness, tissue damage, and inflammation, leading to improved control and quality of life.

Administration of an Anal Bulking Agent With Polyacrylate-Polyalcohol Copolymer Particles Versus Endoanal Electrical Stimulation With Biofeedback for the Management of Mild and Moderate Anal Incontinence: A Randomized Prospective Study.Combined application of chondroitinase ABC and photobiomodulation with low-intensity laser on the anal sphincter repair in rabbit.Systematic Review of Surgical Treatments for Fecal Incontinence.