Sacral Neuromodulation as Treatment for Fecal Incontinence (LLLT-FI)

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.

Study Overview

• Status: Recruiting
• Conditions: Fecal Incontinence
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jihong Chen, MD PhD; Phone Number: 1-226-3439909; Email: chen338@mcmaster.ca
• Study Contact Backup: Name: Jan D Huizinga, PhD; Phone Number: 1-226-3438888; Email: huizinga@mcmaster.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N3Z5
      • Recruiting
      • McMaster University
      • Contact: Jihong Chen, MD PhD; Email: chen338@mcmaster.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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: Photobiomodulation; Sacral neuromodulation; BioFlex laser stimulation

What is the study measuring?

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7. doi: 10.1007/BF02237236.
• Vaizey CJ, Carapeti E, Cahill JA, Kamm MA. Prospective comparison of faecal incontinence grading systems. Gut. 1999 Jan;44(1):77-80. doi: 10.1136/gut.44.1.77.
• Forte ML, Andrade KE, Butler M, Lowry AC, Bliss DZ, Slavin JL, Kane RL. Treatments for Fecal Incontinence [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2016 Mar. Report No.: 15(16)-EHC037-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK356097/

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2019
• Primary Completion (Anticipated): February 1, 2025
• Study Completion (Anticipated): February 1, 2027

Study Registration Dates

• First Submitted: January 30, 2019
• First Submitted That Met QC Criteria: January 30, 2019
• First Posted (Actual): January 31, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Anorectal manometry; Fecal Incontinence
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: McMasterChenFI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No