Using low level laser therapy to treat fecal incontinence
Sacral Neuromodulation as Treatment for Fecal Incontinence
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 6 Years to 80 Years |
| Sex | All |
| Sponsor | McMaster University Academic / other |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT03825575 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients experiencing severe refractory fecal incontinence.
Not a fit: Patients who are pregnant, have malignancies in the treatment area, or are light sensitive may not benefit from this study.
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 performed: While this approach is novel, similar studies exploring laser therapy for other conditions have shown promising results.
Eligibility criteria
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 this trial is running
Hamilton, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.