Multimodal Stimulation Before and After Sacral Nerve Stimulation for Irritable Bowel Syndrome
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
sacral nerve stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome, Sacral Nerve Stimulation, Gastro-colic response, Multimodal Stimulation
Eligibility 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
Sites / Locations
- Surgical Research Unit, Department of Surgery P, Aarhus University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
sacral nerve stimulation
Arm Description
A single armed study to evaluate the on the gastro-colic response in IBS patients treated with sacral nerve stimulation
Outcomes
Primary Outcome Measures
Cross sectional area
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
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
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
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
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
Full Information
NCT ID
NCT01950715
First Posted
September 12, 2013
Last Updated
May 16, 2018
Sponsor
University of Aarhus
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT01950715
Brief Title
Multimodal Stimulation Before and After Sacral Nerve Stimulation for Irritable Bowel Syndrome
Official Title
Evaluation of the Gastro-colic Response in IBS Patients Treated With Sacral Nerve Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Medtronic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Irritable Bowel Syndrome, Sacral Nerve Stimulation, Gastro-colic response, Multimodal Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sacral nerve stimulation
Arm Type
Other
Arm Description
A single armed study to evaluate the on the gastro-colic response in IBS patients treated with sacral nerve stimulation
Intervention Type
Device
Intervention Name(s)
sacral nerve stimulation
Other Intervention Name(s)
External pacemaker, model 3625, Medtronic Inc.
Intervention Description
Sacral nerve stimulation
Primary Outcome Measure Information:
Title
Cross sectional area
Description
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
Time Frame
Change from baseline in cross sectional area at 6 weeks of stimulation
Secondary Outcome Measure Information:
Title
Wall stiffness
Description
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
Time Frame
Change from baseline in wall stiffness at 6 weeks of stimulation
Title
Compliance
Description
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
Time Frame
Change from baseline in compliance at 6 weeks of stimulation
Title
Cold
Description
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
Time Frame
Change from baseline in cold tolerance at 6 weeks of stimulation
Title
Heat
Description
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
Time Frame
Change from baseline in heat tolerance at 6 weeks of stimulation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janne Fassov, PhD
Organizational Affiliation
Surgical Research Unit, Department of Surgery P, Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Surgical Research Unit, Department of Surgery P, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Multimodal Stimulation Before and After Sacral Nerve Stimulation for Irritable Bowel Syndrome
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