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NCT Number: NCT02294760

Long-term Sacral Nerve Stimulation for Irritable Bowel Syndrome.

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.

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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 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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Subsensory

Device

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

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

OFF

Device

The stimulation is turned OFF.

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 19, 2014
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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