Sacral Neuromodulation as Treatment for Fecal Incontinence
LLLT-FI
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2019
CompletedFirst Posted
Study publicly available on registry
January 31, 2019
CompletedStudy Start
First participant enrolled
September 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
ExpectedApril 5, 2022
April 1, 2022
5.4 years
January 30, 2019
April 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in number of fecal incontinence episodes
Number of fecal incontinence episodes per week
4 weeks and 12 weeks
Secondary Outcomes (5)
Change in Quality of Life
4 weeks and 12 weeks
Change in symptoms score
4 and 12 weeks
Change in anal sphincter tone
12 weeks
Change in increase of anal sphincter pressure during squeezing
12 weeks
Change in squeezing duration
12 weeks
Study Arms (1)
Incontinence and low level laser therapy
EXPERIMENTALIntervention: Low level laser therapy (sacral neuromodulation or photobiomodulation) will be administered to patients with fecal incontinence
Interventions
A 3 week treatment period with a total of 8 treatments of 1 hour over the sacral spinal cord
Eligibility Criteria
You may qualify if:
- Patients with fecal incontinence
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
McMaster University
Hamilton, Ontario, L8N3Z5, Canada
Related Publications (3)
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/
PMID: 27099893BACKGROUNDVaizey 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.
PMID: 9862829BACKGROUNDRockwood 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.
PMID: 10813117BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jihong Chen, MD PhD
McMaster University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 30, 2019
First Posted
January 31, 2019
Study Start
September 8, 2019
Primary Completion
February 1, 2025
Study Completion (Estimated)
February 1, 2027
Last Updated
April 5, 2022
Record last verified: 2022-04