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

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ClinicalTrials.gov Identifier: NCT00919672
Recruitment Status : Completed
First Posted : June 12, 2009
Last Update Posted : May 17, 2018
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
University of Aarhus

Tracking Information
First Submitted Date  ICMJE May 25, 2009
First Posted Date  ICMJE June 12, 2009
Last Update Posted Date May 17, 2018
Study Start Date  ICMJE April 2009
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2012)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2009)
Comparing the investigations with MTS and impedance planimetry in the the two periods (ON/OFF periods) in the single IBS patient. Nonparametrics tests. [ Time Frame: 2 months ]
Change History Complete list of historical versions of study NCT00919672 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Irritable Bowel Syndrome (IBS) With Sacral Nerve Stimulation
Official Title  ICMJE Treatment of Irritable Bowel Syndrome (IBS) With Sacral Nerve Stimulation. A Blinded, Randomized Crossover Study
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Irritable Bowel Syndrome
Intervention  ICMJE 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 Name: Irritable Bowel Syndrome
Study Arms  ICMJE
  • 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.
    Intervention: Device: 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.
    Intervention: Device: Sacral nerve stimulation
Publications * Fassov J, Lundby L, Worsøe J, Buntzen S, Laurberg S, Krogh K. A randomised, controlled study of small intestinal motility in patients treated with sacral nerve stimulation for irritable bowel syndrome. BMC Gastroenterol. 2014 Jun 25;14:111. doi: 10.1186/1471-230X-14-111.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 16, 2018)
21
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2009)
28
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00919672
Other Study ID Numbers  ICMJE 20070218,JLF
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Aarhus
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE Medtronic
Investigators  ICMJE
Study Director: Lilli Lundbye, PhD Analfysiologisk Klinik, University Hospital of Aarhus
PRS Account University of Aarhus
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP