Multimodal Stimulation Before and After Sacral Nerve Stimulation for Irritable Bowel Syndrome

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Device: sacral nerve stimulation

• Registration Number: NCT01950715
• Lead Sponsor: University of Aarhus

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. 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.

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 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).

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-12
• Study First Submitted QC: 2013-09-22
• Study First Posted: 2013-09-25
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-16
• Last Update Posted: 2018-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 questionnaire evaluated at baseline

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sacral nerve stimulation	sacral nerve stimulation	A single armed study to evaluate the on the gastro-colic response in IBS patients treated with sacral nerve stimulation

Primary Outcome Measures

Name	Time	Method
Cross sectional area	Change from baseline in cross sectional area at 6 weeks of stimulation	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

Secondary Outcome Measures

Name	Time	Method
Compliance	Change from baseline in compliance at 6 weeks of stimulation	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
Cold	Change from baseline in cold tolerance at 6 weeks of stimulation	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
Wall stiffness	Change from baseline in wall stiffness at 6 weeks of stimulation	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
Heat	Change from baseline in heat tolerance at 6 weeks of stimulation	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

Trial Locations

Locations (1)

Surgical Research Unit, Department of Surgery P, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark