Sacral Neurostimulation for Inflammatory Bowel Disease, a Pilot Study

Completed

• Conditions: Inflammatory Bowel Disease; Ulcerative Colitis; 10017969

• Registration Number: NL-OMON47585
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

- distal colitis with refractory symptoms on enteral steroids
- age >/<= 18 years
- endoscopic disease activity
- informed consent

Exclusion Criteria

- Previous rectal of sigmoid surgery
- Presence of a stoma
- No or poor understanding of Dutch language
- Cognitive not able to provide required information in follow-up

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>the primary objective is to investigate the feasibility of the use of SNS as a<br /><br>potential treatment for distal colitis in patients with inflammatory bowel<br /><br>disease. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Objective(s):<br /><br>- whether there is a beneficial effect of sacral neurostimulation on disease<br /><br>activity and severity by a combination of parameters: endoscopic disease<br /><br>severity score, fecal calprotectin and serum CRP levels.<br /><br>- Patient reported disease symptoms (SIBDQ)<br /><br>- Histopathologic changes in biopsies<br /><br>- Bowel wall integrity and permeability<br /><br>- Bowel wall inflammation activity<br /><br>- Patient reported quality of life<br /><br>- Reduction of anti-inflammatory medication<br /><br>- Side effects<br /><br>- Costs of care</p><br>