NCT03825575
Recruiting
Not Applicable
Sacral Neuromodulation as Treatment for Fecal Incontinence
ConditionsFecal Incontinence
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fecal Incontinence
- Sponsor
- McMaster University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in number of fecal incontinence episodes
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Jihong Chen
Assistant Professor
McMaster University
Eligibility 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.
Outcomes
Primary Outcomes
Change in number of fecal incontinence episodes
Time Frame: 4 weeks and 12 weeks
Number of fecal incontinence episodes per week
Secondary Outcomes
- Change in anal sphincter tone(12 weeks)
- Change in increase of anal sphincter pressure during squeezing(12 weeks)
- Change in squeezing duration(12 weeks)
- Change in Quality of Life(4 weeks and 12 weeks)
- Change in symptoms score(4 and 12 weeks)
Study Sites (1)
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