Subsensory Sacral Nerve Stimulation for Irritable Bowel Syndrome

Study Overview
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Brief Summary
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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 have shown changes in both colonic motility and rectal sensibility. We have previously shown IBS patients to benefit from sacral nerves stimulation. With the present study, we aim to evaluate if subsensory sacral nerve stimulation is as effective as suprasensory sacral nerve stimulation.

Detailed Description
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Twenty four patients with IBS-D or IBS-M according to the ROME III criteria, will be enrolled in the study. Having meet inclusion criteria, the patients are randomised to receive either OFF-subsensory or subsensory-OFF stimulation in a 2+2-week period followed by 2 weeks of suprasensory stimulation. Hereby rendering a percutaneous nerve evaluation (PNE) test of a total of 6 weeks. 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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A Randomised, Controlled Crossover Study of Subsensory Sacral Nerve Stimulation for Irritable Bowel Syndrome

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Device: Subsensory
* Device: OFF
* Drug: Suprasensory


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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-D or IBS-M according to the Rome III criteria Minimum average of 40 points in the symptom quistionnaire evaluated at baseline Exclusion Criteria: 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

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OFF, subsensory, suprasensory<br>Here the stimulator is turned OFF for the first 2 weeks, then set subsensory (90% of sensory threshold) for the next 2 weeks and finally set suprasensory for the last 2 weeks. | Device: Subsensory<br>* The stimulation is here set to 90% of the sensory threshold<br>* Other names: Device: External pacemaker, model 3625, Medtronic Inc.;Device: OFF<br>* The stimulation is here turned OFF<br>* Other names: Device: External pacemaker, model 3625, Medtronic Inc.;Drug: Suprasensory<br>* The stimulation is here set suprasensory<br>* Other names: Device: External pacemaker, model 3625, Medtronic Inc.;|
| Active Comparator: Subsensory, OFF, suprasensory<br>Here the stimulator is set subsensory (90% of sensory threshold), then turned OFF for the next 2 weeks and finally set suprasensory in the last 2 weeks. | Device: Subsensory<br>* The stimulation is here set to 90% of the sensory threshold<br>* Other names: Device: External pacemaker, model 3625, Medtronic Inc.;Device: OFF<br>* The stimulation is here turned OFF<br>* Other names: Device: External pacemaker, model 3625, Medtronic Inc.;Drug: Suprasensory<br>* The stimulation is here set suprasensory<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 questionnaire | The GRSRS-IBS questionnaire is filled in every week during the test period allowing comparison between OFF, subsensory and suprasensory stimulation | Every week during the 6 weeks test period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irritable Bowel Syndrome - Impact Scale questionnaire | The IBS-IS questionnaire is filled in every week during the test period allowing comparison of quality of life between OFF, subsensory and suprasensory stimulation | Every week during the 6 weeks test period | 

 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, Bowel habits