Sacral Neuromodulation as Treatment for Fecal Incontinence (LLLT-FI)

McMaster University

Status: Enrolling

Conditions: Fecal Incontinence

Treatments: Device: Low level laser therapy (LLLT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03825575

McMasterChenFI

Details and patient eligibility

About

The objective of this study is to investigate if low level laser therapy will do more good than harm for patients with severe refractory fecal incontinence. It is a proof of concept study without a placebo arm.

Full description

The therapy consists of a 3 week treatment with a total of 8 sessions of low level laser therapy. Effects will be assessed using symptoms and quality of life questionnaires and physiological assessments of pelvic floor function, at 4 weeks and 12 weeks after beginning of treatment.

Enrollment: 20 estimated patients

Sex: All

Ages: 6 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Incontinence and low level laser therapy

Experimental group

Description:

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

Treatment:

Device: Low level laser therapy (LLLT)