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

Primary Purpose

Fecal Incontinence

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Low level laser therapy (LLLT)
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fecal Incontinence focused on measuring Fecal Incontinence, Anorectal manometry

Eligibility Criteria

6 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • McMaster UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Incontinence and low level laser therapy

Arm Description

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

Outcomes

Primary Outcome Measures

Change in number of fecal incontinence episodes
Number of fecal incontinence episodes per week

Secondary Outcome Measures

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)
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)
Change in anal sphincter tone
Anal sphincter tone (mmHg)
Change in increase of anal sphincter pressure during squeezing
Difference between anal sphincter squeeze pressure and resting pressure (mmHg)
Change in squeezing duration
Anal sphincter sustained squeezing duration (seconds)

Full Information

First Posted
January 30, 2019
Last Updated
April 4, 2022
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT03825575
Brief Title
Sacral Neuromodulation as Treatment for Fecal Incontinence
Acronym
LLLT-FI
Official Title
Sacral Neuromodulation as Treatment for Fecal Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2019 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
February 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence
Keywords
Fecal Incontinence, Anorectal manometry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Proof of concept
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Incontinence and low level laser therapy
Arm Type
Experimental
Arm Description
Intervention: Low level laser therapy (sacral neuromodulation or photobiomodulation) will be administered to patients with fecal incontinence
Intervention Type
Device
Intervention Name(s)
Low level laser therapy (LLLT)
Other Intervention Name(s)
Sacral neuromodulation, Photobiomodulation, BioFlex laser stimulation
Intervention Description
A 3 week treatment period with a total of 8 treatments of 1 hour over the sacral spinal cord
Primary Outcome Measure Information:
Title
Change in number of fecal incontinence episodes
Description
Number of fecal incontinence episodes per week
Time Frame
4 weeks and 12 weeks
Secondary Outcome Measure Information:
Title
Change in Quality of Life
Description
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
Title
Change in symptoms score
Description
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
Title
Change in anal sphincter tone
Description
Anal sphincter tone (mmHg)
Time Frame
12 weeks
Title
Change in increase of anal sphincter pressure during squeezing
Description
Difference between anal sphincter squeeze pressure and resting pressure (mmHg)
Time Frame
12 weeks
Title
Change in squeezing duration
Description
Anal sphincter sustained squeezing duration (seconds)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jihong Chen, MD PhD
Phone
1-226-3439909
Email
chen338@mcmaster.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Jan D Huizinga, PhD
Phone
1-226-3438888
Email
huizinga@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jihong Chen, MD PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N3Z5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jihong Chen, MD PhD
Email
chen338@mcmaster.ca

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27099893
Citation
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/
Results Reference
background
PubMed Identifier
9862829
Citation
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.
Results Reference
background
PubMed Identifier
10813117
Citation
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.
Results Reference
background

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Sacral Neuromodulation as Treatment for Fecal Incontinence

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