Overview

The BOOM-IBD2 clinical trial is designed to evaluate the effectiveness of sacral neuromodulation for the treatment of IBD.

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Inability to operate the patient programmer