LLLT-FI: Sacral Neuromodulation as Treatment for Fecal Incontinence
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.
|Condition or Disease||Intervention/Treatment||Phase|
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.
Arms and Interventions
|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
Primary Outcome Measures
- Change in number of fecal incontinence episodes [4 weeks and 12 weeks]
Number of fecal incontinence episodes per week
Secondary Outcome Measures
- Change in Quality of Life [4 weeks and 12 weeks]
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 [4 and 12 weeks]
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 [12 weeks]
Anal sphincter tone (mmHg)
- Change in increase of anal sphincter pressure during squeezing [12 weeks]
Difference between anal sphincter squeeze pressure and resting pressure (mmHg)
- Change in squeezing duration [12 weeks]
Anal sphincter sustained squeezing duration (seconds)
Patients with fecal incontinence
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.
Contacts and Locations
Sponsors and Collaborators
- McMaster University
- Principal Investigator: Jihong Chen, MD PhD, McMaster University
Study Documents (Full-Text)None provided.
- 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. Available from http://www.ncbi.nlm.nih.gov/books/NBK356097/
- 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.
- Vaizey CJ, Carapeti E, Cahill JA, Kamm MA. Prospective comparison of faecal incontinence grading systems. Gut. 1999 Jan;44(1):77-80.