Clinical trial Recruiting at 1 site Interventional Ages 6 to 80

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 typeInterventional
Ages6 Years to 80 Years
SexAll
Enrollment20 (estimated)
SponsorMcMaster University
Academic / other
Locations1 site (Hamilton, Ontario)
StatusRecruiting
StartedSeptember 8, 2019
Main results expectedFebruary 1, 2025
Study endsFebruary 1, 2027
Registry record updatedApril 5, 2022
Trial IDNCT03825575 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.