Long-term Sacral Nerve Stimulation for Irritable Bowel Syndrome.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Long-term Efficacy of Sacral Nerve Stimulation for Irritable Bowel Syndrome. A Randomised Controlled Crossover Study

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Device: Subsensory
* Device: OFF


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Subsensory, OFF, subsensory<br>The stimulator is set subsensory for the first 4 weeks (90% of sensory threshold), then turned OFF for the next 4 weeks and finally set subsensory for the last 4 weeks. | Device: Subsensory<br>* The stimulation is set to 90% of the sensory threshold.<br>* Other names: Device: External pacemaker, model 3625, Medtronic Inc.;Device: OFF<br>* The stimulation is turned OFF.<br>* Other names: Device: External pacemaker, model 3625, Medtronic Inc.;|
| Active Comparator: Subsensory, subsensory, OFF<br>The stimulator is set subsensory for the first 4 weeks (90% of sensory threshold), then set subsensory for another 4 weeks and finally turned OFF for the last 4 weeks. | Device: Subsensory<br>* The stimulation is set to 90% of the sensory threshold.<br>* Other names: Device: External pacemaker, model 3625, Medtronic Inc.;Device: OFF<br>* The stimulation is turned OFF.<br>* Other names: Device: External pacemaker, model 3625, Medtronic Inc.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome version | The questionnaire is filled in every week of the 12 week study period | Change in the IBS-specific symptom score between the subsensory and the OFF period in the crossover study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irritable Bowel Syndrome - Impact Scale questionnaire | The questionnaire is filled in every week of the 12 week study period | Change in the IBS-specific quality of life score between the subsensory and the OFF period in the crossover study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Irritable Bowel Syndrome, Sacral Nerve Stimulation, Symptoms, Quality of Life