Long-term Efficacy of Sacral Nerve Stimulation for Irritable Bowel Syndrome. A Randomised Controlled Crossover Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Irritable Bowel Syndrome
- Sponsor
- University of Aarhus
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- The Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome version
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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 bowel syndrome (IBS). Relief of IBS symptoms during SNS is associated with consistent changes in rectal sensitivity and biomechanical wall properties.
The aim of the present study is to evaluate long-term efficacy of sacral nerve stimulation on symptoms and quality of life in patients with IBS in a randomised, placebo-controlled, crossover study.
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 weeks and then randomised to receive either OFF-subsensory or subsensory-OFF stimulation in a 4+4-week period. During the PNE test the effect of the stimulation is evaluated by specific IBS symptom and quality of life questionnaires (GSRS-IBS and IBS-IS) and bowel habit diaries.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
The Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome version
Time Frame: Change in the IBS-specific symptom score between the subsensory and the OFF period in the crossover study
The questionnaire is filled in every week of the 12 week study period
Secondary Outcomes
- Irritable Bowel Syndrome - Impact Scale questionnaire(Change in the IBS-specific quality of life score between the subsensory and the OFF period in the crossover study)