Long-term Sacral Nerve Stimulation for Irritable Bowel Syndrome.

May 16, 2018 updated by: University of Aarhus

Long-term Efficacy of Sacral Nerve Stimulation for Irritable Bowel Syndrome. A Randomised Controlled Crossover Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Surgical Research Unit, Department of Surgery P, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Subsensory, OFF, 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.
Device: Subsensory
The stimulation is set to 90% of the sensory threshold.
Other Names:
  • Device: External pacemaker, model 3625, Medtronic Inc.
Device: OFF
The stimulation is turned OFF.
Other Names:
  • Device: External pacemaker, model 3625, Medtronic Inc.
Active Comparator: Subsensory, subsensory, 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.
Device: Subsensory
The stimulation is set to 90% of the sensory threshold.
Other Names:
  • Device: External pacemaker, model 3625, Medtronic Inc.
Device: OFF
The stimulation is turned OFF.
Other Names:
  • Device: External pacemaker, model 3625, Medtronic Inc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome version
Time Frame: 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
Change in the IBS-specific symptom score between the subsensory and the OFF period in the crossover study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Irritable Bowel Syndrome - Impact Scale questionnaire
Time Frame: 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
Change in the IBS-specific quality of life score between the subsensory and the OFF period in the crossover study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

November 10, 2014

First Submitted That Met QC Criteria

November 14, 2014

First Posted (Estimate)

November 19, 2014

Study Record Updates

Last Update Posted (Actual)

May 17, 2018

Last Update Submitted That Met QC Criteria

May 16, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 44418

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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