Sacral Neuromodulation as Treatment for Fecal Incontinence

Not Applicable

Recruiting

• Conditions: Fecal Incontinence
• Interventions: Device: Low level laser therapy (LLLT)

• Registration Number: NCT03825575
• Lead Sponsor: McMaster University

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.

Study Timeline

• Study First Submitted: 2019-01-30
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-01-31
• Study Start: 2019-09-08
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-05
• Primary Completion: 2025-02-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Incontinence and low level laser therapy	Low level laser therapy (LLLT)	Intervention: Low level laser therapy (sacral neuromodulation or photobiomodulation) will be administered to patients with fecal incontinence

Primary Outcome Measures

Name	Time	Method
Change in number of fecal incontinence episodes	4 weeks and 12 weeks	Number of fecal incontinence episodes per week

Secondary Outcome Measures

Name	Time	Method
Change in anal sphincter tone	12 weeks	Anal sphincter tone (mmHg)
Change in increase of anal sphincter pressure during squeezing	12 weeks	Difference between anal sphincter squeeze pressure and resting pressure (mmHg)
Change in squeezing duration	12 weeks	Anal sphincter sustained squeezing duration (seconds)
Change in Quality of Life	4 weeks and 12 weeks	The Fecal Incontinence Quality of Life Assessment is a subject-completed questionnaire. It is measured in each of four areas of depression/self-perception (7 items), lifestyle (10 items), coping (9 items), and embarrassment (3 items). Area scores are measured on a 1 (worse) to 4 (best) scale and are each the average of their component individual item scores measured on the same scale. The total score is the mean of all non-missing items. A negative change from baseline indicates improvement. Minimum important difference is 4 (Forte et al., 2016)
Change in symptoms score	4 and 12 weeks	St. Mark's Incontinence (Vaizey) Score, it is a scale from 0-24 where 0=perfect continence and 24 is complete continence. Minimal important difference is 3 (Forte et al., 2016)

Trial Locations

Locations (1)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada