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

May 16, 2018 updated by: University of Aarhus

Evaluation of the Gastro-colic Response in IBS Patients Treated With Sacral Nerve Stimulation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

21

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 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

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: sacral nerve stimulation
A single armed study to evaluate the on the gastro-colic response in IBS patients treated with sacral nerve stimulation
Device: sacral nerve stimulation
Sacral nerve stimulation
Other Names:
  • External pacemaker, model 3625, Medtronic Inc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cross sectional area
Time Frame: 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
Change from baseline in cross sectional area at 6 weeks of stimulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wall stiffness
Time Frame: 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
Change from baseline in wall stiffness at 6 weeks of stimulation
Compliance
Time Frame: 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
Change from baseline in compliance at 6 weeks of stimulation
Cold
Time Frame: 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
Change from baseline in cold tolerance at 6 weeks of stimulation
Heat
Time Frame: 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
Change from baseline in heat tolerance at 6 weeks of stimulation

Collaborators and Investigators

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

Sponsor

University of Aarhus

Collaborators

Medtronic

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

September 1, 2013

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

September 12, 2013

First Submitted That Met QC Criteria

September 22, 2013

First Posted (Estimate)

September 25, 2013

Study Record Updates

Last Update Posted (Actual)

May 21, 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

  • 201302, JLF

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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