Sacral Neuromodulation as Treatment for Fecal Incontinence

Fecal Incontinence Clinical Trial

— LLLT-FI  

Official title:

Sacral Neuromodulation as Treatment for Fecal Incontinence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03825575
• Other study ID #: McMasterChenFI
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2019
• Est. completion date: February 1, 2027

Study information

• Verified date: April 2022
• Source: McMaster University
• Contact: Jihong Chen, MD PhD
• Phone: 1-226-3439909
• Email: chen338[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 1, 2027
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

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

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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/ — View Citation

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. — View Citation

Vaizey CJ, Carapeti E, Cahill JA, Kamm MA. Prospective comparison of faecal incontinence grading systems. Gut. 1999 Jan;44(1):77-80. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of fecal incontinence episodes	Number of fecal incontinence episodes per week	4 weeks and 12 weeks
Secondary	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)	4 weeks and 12 weeks
Secondary	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
Secondary	Change in anal sphincter tone	Anal sphincter tone (mmHg)	12 weeks
Secondary	Change in increase of anal sphincter pressure during squeezing	Difference between anal sphincter squeeze pressure and resting pressure (mmHg)	12 weeks
Secondary	Change in squeezing duration	Anal sphincter sustained squeezing duration (seconds)	12 weeks