Status:
COMPLETED
Long-term Sacral Nerve Stimulation for Irritable Bowel Syndrome.
Lead Sponsor:
University of Aarhus
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
A recent randomised, controlled, crossover study has shown that sacral nerve stimulation (SNS) significantly reduces symptoms and improves quality of life of highly selected patients with irritable bo...
Detailed Description
Twenty two patients with IBS-D or IBS-M according to the ROME III criteria, will be enrolled by invitation in the study. Having meet inclusion criteria, the patients are first set subsensory for 4 we...
Eligibility Criteria
Inclusion
- 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 and characterised with IBS-D or IBS-M.
- Patients who have been treated with sacral nerve stimulation for a minimum of 3 years.
Exclusion
- Other 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 diseases.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT02294760
Start Date
November 1 2014
End Date
December 1 2016
Last Update
May 17 2018
Active Locations (1)
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1
Surgical Research Unit, Department of Surgery P, Aarhus University Hospital
Aarhus, Denmark, 8000