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Completed

NCT Number: NCT01948973

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Surgical Research Unit, Department of Surgery P, Aarhus University Hospital

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Subsensory

Device

The stimulation is here set to 90% of the sensory threshold

Other names: Device: External pacemaker, model 3625, Medtronic Inc.

OFF

Device

The stimulation is here turned OFF

Other names: Device: External pacemaker, model 3625, Medtronic Inc.

Suprasensory

Drug

The stimulation is here set suprasensory

Other names: Device: External pacemaker, model 3625, Medtronic Inc.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Medtronic

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Sep 24, 2013
Registry last updated
May 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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