NCT03819062

Sacral Neuromodulation as Treatment for Chronic Constipation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: McMaster University · Academic / Other
• Sex: All
• Age: 6 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to study if low level laser therapy will do more good than harm for patients with severe chronic refractory constipation. It is a proof of concept study without a placebo arm.

Detailed description

Patients will be offered the therapy if High-Resolution Colonic Manometry has shown that coordination between colon motility and recto-anal activity is abnormal and that autonomic nervous system assessment suggests a dysfunction of communication between the spinal cord autonomic nerves and the colon-rectum-anus. The therapy consists of a 3 week treatment with a total of 8 sessions of low level laser therapy. Effects will be assessed using symptom and quality of life questionnaires and physiological assessments of colon and pelvic floor function, at 4 weeks and 12 weeks.

Conditions

• Chronic Constipation

Interventions

Type	Name	Description
DEVICE	Low Level Laser Therapy	A 3 week treatment period with 8 treatment sessions in total.

Timeline

• Start date: 2019-09-08
• Primary completion: 2025-02-01
• Completion: 2027-02-01
• First posted: 2019-01-28
• Last updated: 2022-04-05

Locations

1 site across 1 country: Canada