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Subsensory Sacral Nerve Stimulation for Irritable Bowel Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by University of Aarhus
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01948973
First received: September 11, 2013
Last updated: November 10, 2014
Last verified: November 2014
  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. 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.


Condition Intervention
Irritable Bowel Syndrome
Device: Subsensory
Device: OFF
Drug: Suprasensory

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Controlled Crossover Study of Subsensory Sacral Nerve Stimulation for Irritable Bowel Syndrome

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • The Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome version questionnaire [ Time Frame: Every week during the 6 weeks test period ] [ Designated as safety issue: No ]
    The GRSRS-IBS questionnaire is filled in every week during the test period allowing comparison between OFF, subsensory and suprasensory stimulation


Secondary Outcome Measures:
  • Irritable Bowel Syndrome - Impact Scale questionnaire [ Time Frame: Every week during the 6 weeks test period ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Bowel habit diary [ Time Frame: Every day during the 6 weeks test period ] [ Designated as safety issue: No ]
    The bowel habit diary is filled in every day during the test period allowing comparison between OFF, subsensory and suprasensory stimulation


Estimated Enrollment: 24
Study Start Date: September 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: OFF, subsensory, suprasensory
Here the stimulator is turned OFF for the first 2 weeks, then set subsensory (90% of sensory threshold) for the next 2 weeks and finally set suprasensory for the last 2 weeks.
Device: Subsensory
The stimulation is here set to 90% of the sensory threshold
Other Name: Device: External pacemaker, model 3625, Medtronic Inc.
Device: OFF
The stimulation is here turned OFF
Other Name: Device: External pacemaker, model 3625, Medtronic Inc.
Drug: Suprasensory
The stimulation is here set suprasensory
Other Name: Device: External pacemaker, model 3625, Medtronic Inc.
Active Comparator: Subsensory, OFF, suprasensory
Here the stimulator is set subsensory (90% of sensory threshold), then turned OFF for the next 2 weeks and finally set suprasensory in the last 2 weeks.
Device: Subsensory
The stimulation is here set to 90% of the sensory threshold
Other Name: Device: External pacemaker, model 3625, Medtronic Inc.
Device: OFF
The stimulation is here turned OFF
Other Name: Device: External pacemaker, model 3625, Medtronic Inc.
Drug: Suprasensory
The stimulation is here set suprasensory
Other Name: Device: 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 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.

  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 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
  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: NCT01948973

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       janfas@rm.dk   
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: NCT01948973     History of Changes
Other Study ID Numbers: 1-10-72-170-13, JLF, 1-10-72-170-13
Study First Received: September 11, 2013
Last Updated: November 10, 2014
Health Authority: Denmark: The National Committee on Health Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Irritable Bowel Syndrome
Sacral Nerve Stimulation
Symptoms
Quality of Life
Bowel habits

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

ClinicalTrials.gov processed this record on November 20, 2014