Study of a Small Device Using Sacral Neuromodulation to Treat Ulcerative Colitis by Reducing Bowel Urgency in Adults

What this Trial Is About

Ulcerative colitis is a chronic condition causing swelling and sores in the large intestine. This trial evaluates whether a small device placed under the skin, which sends mild signals to a nerve near the tailbone, can help reduce bowel urgency in adults aged 18 to 85 with ulcerative colitis. The study aims to measure improvement in bowel urgency over 12 weeks using a standard rating scale. All participants receive the investigational neuromodulation device during a same-day procedure. There is no placebo group. After implantation, study visits and monitoring continue for 12 months to assess ongoing effects and safety. Participants will attend scheduled visits for assessments and follow-up over the course of the year. Researchers will evaluate bowel urgency and device operation, ensuring participants can use the patient programmer. Safety and effectiveness data will be collected throughout the study period.

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