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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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. The investigators have previously shown IBS patients to benefit from sacral nerves stimulation. With the present study, the investigators aim to evaluate if sacral nerve stimulation alters the gastro-colic response in IBS patients.
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 will be examined with Multimodal Stimulation at baseline and at six weeks in the sacral nerve stimulation test period.
During the Multimodal Stimulation the patients will have impedance planimetry conducted before and after a standardised meal to evaluate on their gastro-colic response without and during sacral nerve stimulation.
The patients enrolled in the study will in the same time period participate in another study evaluating subsensory sacral nerve stimulation. A study registered at clinical trials.
Here 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 stimulation test period of a total of 6 weeks (a permanent electrode is used).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sacral nerve stimulation | Other | A single armed study to evaluate the on the gastro-colic response in IBS patients treated with sacral nerve stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sacral nerve stimulation | Device | Sacral nerve stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cross sectional area | Patients will be examined with Multimodal Stimulation using impedance planimetry measuring the cross sectional area before and after a standardised meal at baseline and at 6 weeks of stimulation | Change from baseline in cross sectional area at 6 weeks of stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Wall stiffness | Patients will be examined with Multimodal Stimulation using impedance planimetry calculating the wall stiffness before and after a standardised meal at baseline and at 6 weeks of stimulation | Change from baseline in wall stiffness at 6 weeks of stimulation |
| Compliance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janne Fassov, PhD | Surgical Research Unit, Department of Surgery P, Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Surgical Research Unit, Department of Surgery P, Aarhus University Hospital | Aarhus | 8000 | Denmark |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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Patients will be examined with Multimodal Stimulation using impedance planimetry measuring the compliance before and after a standardised meal at baseline and at 6 weeks of stimulation |
| Change from baseline in compliance at 6 weeks of stimulation |
| Cold | Patients will be examined with Multimodal Stimulation using impedance planimetry measuring the cold tolerance before and after a standardised meal at baseline and at 6 weeks of stimulation | Change from baseline in cold tolerance at 6 weeks of stimulation |
| Heat | Patients will be examined with Multimodal Stimulation using impedance planimetry measuring the heat tolerance before and after a standardised meal at baseline and at 6 weeks of stimulation | Change from baseline in heat tolerance at 6 weeks of stimulation |
| D004066 | Digestive System Diseases |