Sacral Neuromodulation as Treatment for Fecal Incontinence
NCT ID: NCT03825575
Last Updated: 2022-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2019-09-08
2027-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Incontinence and low level laser therapy
Intervention: Low level laser therapy (sacral neuromodulation or photobiomodulation) will be administered to patients with fecal incontinence
Low level laser therapy (LLLT)
A 3 week treatment period with a total of 8 treatments of 1 hour over the sacral spinal cord
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
6 Years
80 Years
ALL
No
Sponsors
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McMaster University
OTHER
Responsible Party
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Jihong Chen
Assistant Professor
Principal Investigators
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Jihong Chen, MD PhD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
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McMaster University
Hamilton, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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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/
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.
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.
Other Identifiers
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McMasterChenFI
Identifier Type: -
Identifier Source: org_study_id
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