Long-term Sacral Nerve Stimulation for Irritable Bowel Syndrome.

Not Applicable

Completed

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

• Registration Number: NCT02294760
• Lead Sponsor: University of Aarhus

Brief Summary

A recent randomised, controlled, crossover study has shown that sacral nerve stimulation (SNS) significantly reduces symptoms and improves quality of life of highly selected patients with irritable bowel syndrome (IBS). Relief of IBS symptoms during SNS is associated with consistent changes in rectal sensitivity and biomechanical wall properties.

The aim of the present study is to evaluate long-term efficacy of sacral nerve stimulation on symptoms and quality of life in patients with IBS in a randomised, placebo-controlled, crossover study.

Detailed Description

Twenty two patients with IBS-D or IBS-M according to the ROME III criteria, will be enrolled by invitation in the study.

Having meet inclusion criteria, the patients are first set subsensory for 4 weeks and then randomised to receive either OFF-subsensory or subsensory-OFF stimulation in a 4+4-week period.

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: 2014-11
• Study First Submitted: 2014-11-10
• Study First Submitted QC: 2014-11-14
• Study First Posted: 2014-11-19
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-16
• Last Update Posted: 2018-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Patients who are psychologically stable and suitable for intervention and able to provide informed consent
• Patients who are diagnosed with IBS according to the Rome III criteria and characterised with IBS-D or IBS-M.
• Patients who have been treated with sacral nerve stimulation for a minimum of 3 years.

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Exclusion Criteria

• Other 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 diseases.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Subsensory, OFF, subsensory	OFF	The stimulator is set subsensory for the first 4 weeks (90% of sensory threshold), then turned OFF for the next 4 weeks and finally set subsensory for the last 4 weeks.
Subsensory, OFF, subsensory	Subsensory	The stimulator is set subsensory for the first 4 weeks (90% of sensory threshold), then turned OFF for the next 4 weeks and finally set subsensory for the last 4 weeks.
Subsensory, subsensory, OFF	OFF	The stimulator is set subsensory for the first 4 weeks (90% of sensory threshold), then set subsensory for another 4 weeks and finally turned OFF for the last 4 weeks.
Subsensory, subsensory, OFF	Subsensory	The stimulator is set subsensory for the first 4 weeks (90% of sensory threshold), then set subsensory for another 4 weeks and finally turned OFF for the last 4 weeks.

Primary Outcome Measures

Name	Time	Method
The Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome version	Change in the IBS-specific symptom score between the subsensory and the OFF period in the crossover study	The questionnaire is filled in every week of the 12 week study period

Secondary Outcome Measures

Name	Time	Method
Irritable Bowel Syndrome - Impact Scale questionnaire	Change in the IBS-specific quality of life score between the subsensory and the OFF period in the crossover study	The questionnaire is filled in every week of the 12 week study period

Trial Locations

Locations (1)

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