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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.
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.
Age
6 - 80 years
Sex
ALL
Healthy Volunteers
No
McMaster University
Hamilton, Ontario, Canada
Start Date
September 8, 2019
Primary Completion Date
February 1, 2025
Completion Date
February 1, 2027
Last Updated
April 5, 2022
20
ESTIMATED participants
Low level laser therapy (LLLT)
DEVICE
Lead Sponsor
McMaster University
NCT05626816
NCT06532123
NCT06186765
Data Source & Attribution
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