The main goal is to find out if bowel urgency gets better after 12 weeks, using a standard rating scale for bowel urgency. Adults ages 18 to 85 with ulcerative colitis may be able to join. Everyone in the study gets the device. There is no placebo group. Study visits continue for 12 months.
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female
18 to 85 years of age
Diagnosed with ulcerative colitis
Ability and willingness to consent to participate by signing the informed consent form
Ability to comply with the protocol and willingness to comply with all follow up requirements
You may not be if
Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound the results of the study
Any psychiatric or personality disorder at the discretion of the study investigator
Any active bacterial infection with a risk of bacteremia or sepsis (e.g. presence of abscess)
Active clostridium difficile infection of the colon
Active cytomegalovirus (CMV) infection of the colon
Evidence of colonic perforation
Fulminant colitis requiring emergency surgery
Microscopic, ischemic or infectious colitis
Unresected neoplasia of the colon
Colonic stricture unable to pass a colonoscope
Current evidence of cancer in the gastrointestinal tract
Current participation in another clinical trial
Previous history of surgery for ulcerative colitis, or probably to require such intervention
Previously implanted with a neurostimulation device or participated in a neurostimulation trial
