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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Incontinence and low level laser therapy | Experimental | Intervention: Low level laser therapy (sacral neuromodulation or photobiomodulation) will be administered to patients with fecal incontinence |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low level laser therapy (LLLT) | Device | A 3 week treatment period with a total of 8 treatments of 1 hour over the sacral spinal cord |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in number of fecal incontinence episodes | Number of fecal incontinence episodes per week | 4 weeks and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Patients with fecal incontinence
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jihong Chen, MD PhD | Contact | 1-226-3439909 | chen338@mcmaster.ca | |
| Jan D Huizinga, PhD | Contact | 1-226-3438888 | huizinga@mcmaster.ca |
| Name | Affiliation | Role |
|---|---|---|
| Jihong Chen, MD PhD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University | Recruiting | Hamilton | Ontario | L8N3Z5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27099893 | Background | 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/ | |
| 9862829 | Background | 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. |
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| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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Proof of concept
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|
| 4 weeks and 12 weeks |
| 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) | 4 and 12 weeks |
| Change in anal sphincter tone | Anal sphincter tone (mmHg) | 12 weeks |
| Change in increase of anal sphincter pressure during squeezing | Difference between anal sphincter squeeze pressure and resting pressure (mmHg) | 12 weeks |
| Change in squeezing duration | Anal sphincter sustained squeezing duration (seconds) | 12 weeks |
| 10813117 | Background | 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. |