Irritable Bowel Syndrome
Conditions
Keywords
Irritable Bowel Syndrome, Sacral Nerve Stimulation, Symptoms, Quality of Life, Bowel habits
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 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
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.
Interventions
DEVICESubsensory
The stimulation is here set to 90% of the sensory threshold
DEVICEOFF
The stimulation is here turned OFF
DRUGSuprasensory
The stimulation is here set suprasensory
Sponsors
Medtronic
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome version questionnaire | Every week during the 6 weeks test period | The GRSRS-IBS questionnaire is filled in every week during the test period allowing comparison between OFF, subsensory and suprasensory stimulation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Irritable Bowel Syndrome - Impact Scale questionnaire | Every week during the 6 weeks test period | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Bowel habit diary | Every day during the 6 weeks test period | The bowel habit diary is filled in every day during the test period allowing comparison between OFF, subsensory and suprasensory stimulation |
Countries
Denmark
Outcome results
None listed