Multimodal Stimulation Before and After Sacral Nerve Stimulation for Irritable Bowel Syndrome

This study is currently recruiting participants.
Verified September 2013 by University of Aarhus
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01950715
First received: September 12, 2013
Last updated: September 22, 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 changes in both colonic motility and rectal sensibility. The investigators have previously shown IBS patients to benefit from sacral nerves stimulation. With the present study, the investigators aim to evaluate if sacral nerve stimulation alters the gastro-colic response in IBS patients.


Condition Intervention
Irritable Bowel Syndrome
Device: sacral nerve stimulation

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Gastro-colic Response in IBS Patients Treated With Sacral Nerve Stimulation

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Cross sectional area [ Time Frame: Change from baseline in cross sectional area at 6 weeks of stimulation ] [ Designated as safety issue: No ]
    Patients will be examined with Multimodal Stimulation using impedance planimetry measuring the cross sectional area before and after a standardised meal at baseline and at 6 weeks of stimulation


Secondary Outcome Measures:
  • Wall stiffness [ Time Frame: Change from baseline in wall stiffness at 6 weeks of stimulation ] [ Designated as safety issue: No ]
    Patients will be examined with Multimodal Stimulation using impedance planimetry calculating the wall stiffness before and after a standardised meal at baseline and at 6 weeks of stimulation

  • Compliance [ Time Frame: Change from baseline in compliance at 6 weeks of stimulation ] [ Designated as safety issue: No ]
    Patients will be examined with Multimodal Stimulation using impedance planimetry measuring the compliance before and after a standardised meal at baseline and at 6 weeks of stimulation

  • Cold [ Time Frame: Change from baseline in cold tolerance at 6 weeks of stimulation ] [ Designated as safety issue: No ]
    Patients will be examined with Multimodal Stimulation using impedance planimetry measuring the cold tolerance before and after a standardised meal at baseline and at 6 weeks of stimulation

  • Heat [ Time Frame: Change from baseline in heat tolerance at 6 weeks of stimulation ] [ Designated as safety issue: No ]
    Patients will be examined with Multimodal Stimulation using impedance planimetry measuring the heat tolerance before and after a standardised meal at baseline and at 6 weeks of stimulation


Estimated Enrollment: 24
Study Start Date: September 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
sacral nerve stimulation
A single armed study to evaluate the on the gastro-colic response in IBS patients treated with sacral nerve stimulation
Device: sacral nerve stimulation
Other Name: External pacemaker, model 3625, Medtronic Inc.

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 will be examined with Multimodal Stimulation at baseline and at six weeks in the sacral nerve stimulation test period.

During the Multimodal Stimulation the patients will have impedance planimetry conducted before and after a standardised meal to evaluate on their gastro-colic response without and during sacral nerve stimulation.

The patients enrolled in the study will in the same time period participate in another study evaluating subsensory sacral nerve stimulation. A study registered at clinical trials.

Here 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 stimulation test period of a total of 6 weeks (a permanent electrode is used).

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
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-D or IBS-M according to the Rome III criteria
  • Minimum average of 40 points in the symptom questionnaire 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01950715

Contacts
Contact: Janne Fassov, PhD janfas@rm.dk

Locations
Denmark
Surgical Research Unit, Department of Surgery P, Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Janne Fassov, PhD         
Contact: Lilli Lundby, PhD         
Principal Investigator: Janne Fassov, PhD         
Sponsors and Collaborators
University of Aarhus
Medtronic
Investigators
Principal Investigator: Janne Fassov, PhD Surgical Research Unit, Department of Surgery P, Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01950715     History of Changes
Other Study ID Numbers: 201302, JLF
Study First Received: September 12, 2013
Last Updated: September 22, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Irritable Bowel Syndrome
Sacral Nerve Stimulation
Gastro-colic response
Multimodal Stimulation

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 April 17, 2014