Subsensory Sacral Nerve Stimulation for Irritable Bowel Syndrome

May 16, 2018 updated by: University of Aarhus

A Randomised, Controlled Crossover Study of Subsensory Sacral Nerve Stimulation for Irritable Bowel Syndrome

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.

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 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 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 quistionnaire 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: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: OFF, subsensory, 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.
Device: Subsensory
The stimulation is here set to 90% of the sensory threshold
Other Names:
  • Device: External pacemaker, model 3625, Medtronic Inc.
Device: OFF
The stimulation is here turned OFF
Other Names:
  • Device: External pacemaker, model 3625, Medtronic Inc.
Drug: Suprasensory
The stimulation is here set suprasensory
Other Names:
  • Device: External pacemaker, model 3625, Medtronic Inc.
ACTIVE_COMPARATOR: Subsensory, OFF, 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.
Device: Subsensory
The stimulation is here set to 90% of the sensory threshold
Other Names:
  • Device: External pacemaker, model 3625, Medtronic Inc.
Device: OFF
The stimulation is here turned OFF
Other Names:
  • Device: External pacemaker, model 3625, Medtronic Inc.
Drug: Suprasensory
The stimulation is here set suprasensory
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 questionnaire
Time Frame: 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
Every week during the 6 weeks test period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Irritable Bowel Syndrome - Impact Scale questionnaire
Time Frame: 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
Every week during the 6 weeks test period

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bowel habit diary
Time Frame: Every day during the 6 weeks test period
The bowel habit diary is filled in every day during the test period allowing comparison between OFF, subsensory and suprasensory stimulation
Every day during the 6 weeks test period

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 11, 2013

First Submitted That Met QC Criteria

September 23, 2013

First Posted (ESTIMATE)

September 24, 2013

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

  • 1-10-72-170-13, JLF
  • 1-10-72-170-13 (OTHER: VEK)

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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