Fecal Incontinence
Conditions
Keywords
Fecal Incontinence, Anorectal manometry
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.
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
A 3 week treatment period with a total of 8 treatments of 1 hour over the sacral spinal cord
Sponsors
McMaster University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Proof of concept
Eligibility
Sex/Gender
ALL
Age
6 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in number of fecal incontinence episodes | 4 weeks and 12 weeks | Number of fecal incontinence episodes per week |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Canada
Contacts
Primary ContactJihong Chen, MD PhD
Backup ContactJan D Huizinga, PhD
Outcome results
None listed