Status:
COMPLETED
Treatment of Irritable Bowel Syndrome (IBS) With Sacral Nerve Stimulation
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Medtronic
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Sacral nerve stimulation (SNS) has become a well-established treatment for patients with fecal incontinence since 1995. The mechanism of action of SNS is still not fully understood but recent studies ...
Eligibility Criteria
Inclusion
- Patients aged over 18
- Patients who are psychologically stable and suitable for intervention and able to provide informed consent.
- Patients who are diagnosed with IBS according to the Rome III criteria
- Minimum 30% reduction of the IBS symptoms during the PNE-test (a criteria for implantation of the neurostimulator)
Exclusion
- Overt bowel diseases including inflammatory bowel disease
- Pregnant or breast feeding
- Patients who are considered unable to follow the planned programme of the study, including mentally illness or physiological instability
- Patients who are on medication with known influence on gastrointestinal motility including those for thyroid disease, diabetes mellitus, celiac disease and neurological disease
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00919672
Start Date
April 1 2009
End Date
November 1 2013
Last Update
May 17 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Analfysiologisk Klinik, University Hospital of Aarhus
Aarhus, Denmark, 8000