Sacral Neuromodulation as Treatment for Fecal Incontinence

McMaster University20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fecal Incontinence

Interventions

Low level laser therapy (LLLT)DEVICE

A 3 week treatment period with a total of 8 treatments of 1 hour over the sacral spinal cord

Eligibility

Sex: ALLMin age: 6 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

McMaster University

Hamilton, Ontario, Canada

RECRUITING

Outcomes

Primary Outcomes

Change in number of fecal incontinence episodes

Number of fecal incontinence episodes per week

Time frame: 4 weeks and 12 weeks

Secondary Outcomes

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)

Time frame: 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)

Time frame: 4 and 12 weeks

Change in anal sphincter tone

Anal sphincter tone (mmHg)

Time frame: 12 weeks

Change in increase of anal sphincter pressure during squeezing

Difference between anal sphincter squeeze pressure and resting pressure (mmHg)

Time frame: 12 weeks

Change in squeezing duration

Anal sphincter sustained squeezing duration (seconds)

Time frame: 12 weeks