Subsensory Sacral Nerve Stimulation for Irritable Bowel Syndrome

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Device: Subsensory; Device: OFF; Drug: Suprasensory

• Registration Number: NCT01948973
• 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. 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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-11
• Study First Submitted QC: 2013-09-23
• Study First Posted: 2013-09-24
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-16
• Last Update Posted: 2018-05-17

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 quistionnaire 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: CROSSOVER

Arm && Interventions

Group	Intervention	Description
OFF, subsensory, suprasensory	Subsensory	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.
Subsensory, OFF, suprasensory	Subsensory	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.
OFF, subsensory, suprasensory	OFF	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.
OFF, subsensory, suprasensory	Suprasensory	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.
Subsensory, OFF, suprasensory	Suprasensory	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.
Subsensory, OFF, suprasensory	OFF	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

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