Sacral Neuromodulation as Treatment for Chronic Constipation

What this Trial Is About

Researchers are investigating whether low level laser therapy (LLLT) can benefit patients suffering from severe chronic refractory constipation. This study is a proof of concept without a placebo group and focuses on patients whose autonomic nervous system shows impaired communication between the spinal cord nerves and the colon-rectum-anus area, as determined by high-resolution colonic manometry and autonomic assessments. The goal is to understand if this therapy can improve symptoms and quality of life in these patients. The treatment involves eight sessions of low level laser therapy spread over three weeks. Patients will receive this therapy if tests confirm a lack of coordination between colon movement and recto-anal activity. The effects of the treatment will be evaluated at 4 weeks and 12 weeks after starting therapy using questionnaires about symptoms and quality of life, as well as physiological tests assessing colon and pelvic floor function. Participants will be closely monitored through symptom and quality of life questionnaires, autonomic function tests, and measurements of anal sphincter pressure both at rest and during attempts to defecate. The main outcome measured is the change in the number of bowel movements per week after 12 weeks. Secondary outcomes include changes in symptom scores, quality of life, and anal sphincter function. The study runs from September 2019 and is expected to complete by February 2027.

Sacral Neuromodulation as Treatment for Chronic Constipation