NCT03825575

Sacral Neuromodulation as Treatment for Fecal Incontinence

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: McMaster University · Academic / Other
• Sex: All
• Age: 6 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
DEVICE	Low level laser therapy (LLLT)	A 3 week treatment period with a total of 8 treatments of 1 hour over the sacral spinal cord

Timeline

• Start date: 2019-09-08
• Primary completion: 2025-02-01
• Completion: 2027-02-01
• First posted: 2019-01-31
• Last updated: 2022-04-05

Locations

1 site across 1 country: Canada