Using low level laser therapy to treat fecal incontinence
Official title: Sacral Neuromodulation as Treatment for Fecal Incontinence
Run by McMaster University · NCT03825575 · Data updated 2026-11-12
This study is testing if low level laser therapy can help people with severe fecal incontinence feel better and improve their quality of life.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 80 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | McMaster University Academic / other |
| Locations | 1 site (Hamilton, Ontario) |
| Status | Recruiting |
| Started | September 8, 2019 |
| Main results expected | February 1, 2025 |
| Study ends | February 1, 2027 |
| Registry record updated | April 5, 2022 |
| Trial ID | NCT03825575 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients experiencing severe refractory fecal incontinence.
✕Probably not a fit
Patients who are pregnant, have malignancies in the treatment area, or are light sensitive may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of low level laser therapy (LLLT) for patients suffering from severe refractory fecal incontinence. Participants will undergo a 3-week treatment regimen consisting of 8 sessions of LLLT. The study will assess the therapy's impact on symptoms and quality of life through questionnaires and physiological evaluations of pelvic floor function at 4 and 12 weeks post-treatment. This proof of concept study does not include a placebo group.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with fecal incontinence.
How similar studies have gone: While this approach is novel, similar studies exploring laser therapy for other conditions have shown promising results.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients with fecal incontinence Exclusion Criteria: * Pregnant patients * Known malignancies in the area of treatment * Active bleeding in area of treatment * Active deep vein thrombosis * When tatoos are present at area of treatment * Patients that are light sensitive * Patients who take steroids.
Where it's running
-
McMaster University
Hamilton, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Jihong Chen, MD PhD — McMaster University
- Study coordinator: Jihong Chen, MD PhD
- Email: chen338@mcmaster.ca
- Phone: 1-226-3439909
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Active vs. Passive Anal Sphincter Training in Fecal Incontinence
This home-based trial tests whether adding active sphincter contractions to electrical stimulation helps adults with fecal incontinence more than stimulation alone.
-
Beta-glucan cream added to standard skin care for IAD in hospitalized adults
This study tests whether adding a 0.5% beta-glucan moisturizing cream to usual skin care helps adults with incontinence-associated dermatitis heal faster and feel better.
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R20 Sacral Neuromodulation for Fecal Incontinence: Post‑Market Follow‑Up
This registry test checks how well the Axonics R20 rechargeable device works for adults with fecal incontinence after it’s on the market.
-
High-intensity electromagnetic stimulation for bowel control after J-pouch surgery
Aims to see if the Emsella chair can help people with a J pouch who have fecal incontinence after ulcerative colitis surgery.
-
Intra-rectal Botulinum Toxin Injection for Children with Non-Retentive Fecal Incontinence
This trial tests whether injecting botulinum toxin into the rectum can help children who have frequent non-retentive fecal incontinence that isn’t caused by constipation.
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Investigating the effects of sacral neuromodulation on fecal incontinence and the external anal sphincter
This study is trying to see how a treatment called sacral neuromodulation can help people with fecal incontinence by looking at changes in the muscles around the anus.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.