Sacral Neuromodulation as Treatment for Fecal Incontinence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low level laser therapy (LLLT).
- Who it may be relevant to
- Registry conditions: Fecal Incontinence. Basic parameters: 6 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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
Primary outcome measures
- Change in number of fecal incontinence episodes [Time frame: 4 weeks and 12 weeks]
Secondary outcome measures (5)
- Change in Quality of Life [Time frame: 4 weeks and 12 weeks]
- Change in symptoms score [Time frame: 4 and 12 weeks]
- Change in anal sphincter tone [Time frame: 12 weeks]
- Change in increase of anal sphincter pressure during squeezing [Time frame: 12 weeks]
- Change in squeezing duration [Time frame: 12 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- McMaster University — Hamilton
Publications
- 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 27099893
- 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. PMID 9862829
- 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. PMID 10813117
Identifiers
NCT: NCT03825575 · McMasterChenFI