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| ID | Type | Description | Link |
|---|---|---|---|
| 1-10-72-170-13 | Other Identifier | VEK |
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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. 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OFF, subsensory, suprasensory | Active Comparator | 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. |
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| Subsensory, OFF, suprasensory | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subsensory | Device | The stimulation is here set to 90% of the sensory threshold |
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| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Bowel habit diary | The bowel habit diary is filled in every day during the test period allowing comparison between OFF, subsensory and suprasensory stimulation | Every day during the 6 weeks test period |
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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39754648 | Derived | Fassov J, Hoyer KL, Lundby L, Laurberg S, Scott SM, Krogh K. Long-term efficacy and safety of sacral neuromodulation for diarrhoea-predominant and mixed irritable bowel syndrome. Tech Coloproctol. 2025 Jan 4;29(1):41. doi: 10.1007/s10151-024-03066-3. |
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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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| OFF | Device | The stimulation is here turned OFF |
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| Suprasensory | Drug | The stimulation is here set suprasensory |
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| D004066 | Digestive System Diseases |