Sacral Neuromodulation as Treatment for Fecal Incontinence

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Sacral Neuromodulation as Treatment for Fecal Incontinence

Conditions
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Fecal Incontinence

Intervention / Treatment
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* Device: Low level laser therapy (LLLT)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Proof of concept
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Incontinence and low level laser therapy<br>Intervention: Low level laser therapy (sacral neuromodulation or photobiomodulation) will be administered to patients with fecal incontinence | Device: Low level laser therapy (LLLT)<br>* A 3 week treatment period with a total of 8 treatments of 1 hour over the sacral spinal cord<br>* Other names: BioFlex laser stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of fecal incontinence episodes | Number of fecal incontinence episodes per week | 4 weeks and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life | 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) | 4 weeks and 12 weeks | 
| Change in symptoms score | 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) | 4 and 12 weeks | 
| Change in anal sphincter tone | Anal sphincter tone (mmHg) | 12 weeks | 
| Change in increase of anal sphincter pressure during squeezing | Difference between anal sphincter squeeze pressure and resting pressure (mmHg) | 12 weeks | 
| Change in squeezing duration | Anal sphincter sustained squeezing duration (seconds) | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fecal Incontinence, Anorectal manometry