Treatment of Irritable Bowel Syndrome (IBS) With Sacral Nerve Stimulation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00919672
First received: May 25, 2009
Last updated: September 11, 2013
Last verified: September 2013
  Purpose

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 that the motility of the whole colon is modulated during the stimulation. This modulation of the colonic motility could be a potential mechanism of an action to relieve the symptoms in patients with IBS.

Twenty eight patients with IBS will be enrolled in the study. They have to meet the ROME III criteria, and also satisfy the criteria for implantation of a neurostimulator.

After a post implantation period where the programming of the neurostimulator is optimised, the patient is randomized in a double blinded design to receive either ON-OFF or OFF-ON stimulation in a 2-month period.

At the end of each period (ON/OFF) the patient will be examined with Magnet Tracking System (MTS) for motility and with impedance planimetry including thermal stimulation (circulating water)for multimodal sensory testing of the rectum.

This is based on the study hypothesis that the motility of the small intestine and the colon is changed in IBS patients according to their subtype (Diarrhoea-IBS, Constipation-IBS and Disordered bowel habit-IBS) compared to healthy persons. And that SNS will affect the motility of the small intestine and the colon in IBS patients as well as SNS will affect the perception of pain/discomfort in the rectum in IBS patients.

The effect of ON-OFF-sacral nerve stimulation on the IBS patients and thereby their IBS symptoms will also be evaluated by an IBS score (GSRS-IBS)and on quality of life by an IBS Impact Scale (IBS-IS) as well as the significance of placebo effect in the treatment of patients with IBS with SNS will be evaluated.


Condition Intervention
Irritable Bowel Syndrome
Device: Sacral nerve stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Irritable Bowel Syndrome (IBS) With Sacral Nerve Stimulation. A Blinded, Randomized Crossover Study

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Comparing the investigations with MTS and impedance planimetry as well as the GSRS-IBS and IBS-IS scores in the the two periods (ON/OFF periods) in the single IBS patient. Nonparametrics tests. [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 28
Study Start Date: April 2009
Estimated Study Completion Date: November 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sacral nerve stimulation ON-OFF
As previously described the patients will be randomized in a blinded design to receive either ON-OFF or OFF-ON stimulation in a 2 month period.
Device: Sacral nerve stimulation
The stimulation is set individually to provide the best possible stimulation for each individual person. This setting is found before the study starts and will not be altered during the study.
Other Names:
  • Irritable Bowel Syndrome
  • Sacral nerve stimulation
Active Comparator: Sacral nerve stimulation OFF-ON
As previously described the patients will be randomized in a blinded design to receive either ON-OFF or OFF-ON stimulation in a 2 month period.
Device: Sacral nerve stimulation
The stimulation is set individually to provide the best possible stimulation for each individual person. This setting is found before the study starts and will not be altered during the study.
Other Names:
  • Irritable Bowel Syndrome
  • Sacral nerve stimulation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 according to the Rome III criteria
  • Minimum 30% reduction of the IBS symptoms during the PNE-test (a criteria for implantation of the neurostimulator)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00919672

Locations
Denmark
Analfysiologisk Klinik, University Hospital of Aarhus
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Medtronic
Investigators
Study Director: Lilli Lundbye, PhD Analfysiologisk Klinik, University Hospital of Aarhus
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00919672     History of Changes
Other Study ID Numbers: 20070218,JLF
Study First Received: May 25, 2009
Last Updated: September 11, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Irritable bowel syndrome
Sacral nerve stimulation
Motility
Pain perception
GSRS-IBS
IBS-IS

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 29, 2014