LLLT-FI: Sacral Neuromodulation as Treatment for Fecal Incontinence

McMaster University (Other)
Overall Status
CT.gov ID

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Low level laser therapy (LLLT)

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 Design

Study Type:
Anticipated Enrollment :
20 participants
Intervention Model:
Single Group Assignment
Intervention Model Description:
Proof of conceptProof of concept
None (Open Label)
Primary Purpose:
Official Title:
Sacral Neuromodulation as Treatment for Fecal Incontinence
Actual Study Start Date :
Sep 8, 2019
Anticipated Primary Completion Date :
Feb 1, 2025
Anticipated Study Completion Date :
Feb 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Incontinence and low level laser therapy

Intervention: Low level laser therapy (sacral neuromodulation or photobiomodulation) will be administered to patients with fecal incontinence

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
Other Names:
  • Sacral neuromodulation
  • Photobiomodulation
  • BioFlex laser stimulation
  • Outcome Measures

    Primary Outcome Measures

    1. Change in number of fecal incontinence episodes [4 weeks and 12 weeks]

      Number of fecal incontinence episodes per week

    Secondary Outcome Measures

    1. 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)

    2. 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)

    3. Change in anal sphincter tone [12 weeks]

      Anal sphincter tone (mmHg)

    4. Change in increase of anal sphincter pressure during squeezing [12 weeks]

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

    5. Change in squeezing duration [12 weeks]

      Anal sphincter sustained squeezing duration (seconds)

    Eligibility Criteria


    Ages Eligible for Study:
    6 Years to 80 Years
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    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.

    Contacts and Locations


    Site City State Country Postal Code
    1 McMaster University Hamilton Ontario Canada L8N3Z5

    Sponsors and Collaborators

    • McMaster University


    • Principal Investigator: Jihong Chen, MD PhD, McMaster University

    Study Documents (Full-Text)

    None provided.

    More Information


    Responsible Party:
    Jihong Chen, Assistant Professor, McMaster University
    ClinicalTrials.gov Identifier:
    Other Study ID Numbers:
    • McMasterChenFI
    First Posted:
    Jan 31, 2019
    Last Update Posted:
    Apr 5, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Keywords provided by Jihong Chen, Assistant Professor, McMaster University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 5, 2022