Back to resultsLong-term Sacral Nerve Stimulation for Irritable Bowel Syndrome.
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Subsensory
OFF
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome, Sacral Nerve Stimulation, Symptoms, Quality of Life
Eligibility Criteria
Inclusion Criteria:
- 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 and characterised with IBS-D or IBS-M.
- Patients who have been treated with sacral nerve stimulation for a minimum of 3 years.
Exclusion Criteria:
- Other 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 diseases.
Sites / Locations
- Surgical Research Unit, Department of Surgery P, Aarhus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Subsensory, OFF, subsensory
Subsensory, subsensory, OFF
Arm Description
The stimulator is set subsensory for the first 4 weeks (90% of sensory threshold), then turned OFF for the next 4 weeks and finally set subsensory for the last 4 weeks.
The stimulator is set subsensory for the first 4 weeks (90% of sensory threshold), then set subsensory for another 4 weeks and finally turned OFF for the last 4 weeks.
Outcomes
Primary Outcome Measures
The Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome version
The questionnaire is filled in every week of the 12 week study period
Secondary Outcome Measures
Irritable Bowel Syndrome - Impact Scale questionnaire
The questionnaire is filled in every week of the 12 week study period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02294760
Brief Title
Long-term Sacral Nerve Stimulation for Irritable Bowel Syndrome.
Official Title
Long-term Efficacy of Sacral Nerve Stimulation for Irritable Bowel Syndrome. A Randomised Controlled Crossover Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A recent randomised, controlled, crossover study has shown that sacral nerve stimulation (SNS) significantly reduces symptoms and improves quality of life of highly selected patients with irritable bowel syndrome (IBS). Relief of IBS symptoms during SNS is associated with consistent changes in rectal sensitivity and biomechanical wall properties.
The aim of the present study is to evaluate long-term efficacy of sacral nerve stimulation on symptoms and quality of life in patients with IBS in a randomised, placebo-controlled, crossover study.
Detailed Description
Twenty two patients with IBS-D or IBS-M according to the ROME III criteria, will be enrolled by invitation in the study.
Having meet inclusion criteria, the patients are first set subsensory for 4 weeks and then randomised to receive either OFF-subsensory or subsensory-OFF stimulation in a 4+4-week period.
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.
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, Symptoms, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subsensory, OFF, subsensory
Arm Type
Active Comparator
Arm Description
The stimulator is set subsensory for the first 4 weeks (90% of sensory threshold), then turned OFF for the next 4 weeks and finally set subsensory for the last 4 weeks.
Arm Title
Subsensory, subsensory, OFF
Arm Type
Active Comparator
Arm Description
The stimulator is set subsensory for the first 4 weeks (90% of sensory threshold), then set subsensory for another 4 weeks and finally turned OFF for the last 4 weeks.
Intervention Type
Device
Intervention Name(s)
Subsensory
Other Intervention Name(s)
Device: External pacemaker, model 3625, Medtronic Inc.
Intervention Description
The stimulation is set to 90% of the sensory threshold.
Intervention Type
Device
Intervention Name(s)
OFF
Other Intervention Name(s)
Device: External pacemaker, model 3625, Medtronic Inc.
Intervention Description
The stimulation is turned OFF.
Primary Outcome Measure Information:
Title
The Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome version
Description
The questionnaire is filled in every week of the 12 week study period
Time Frame
Change in the IBS-specific symptom score between the subsensory and the OFF period in the crossover study
Secondary Outcome Measure Information:
Title
Irritable Bowel Syndrome - Impact Scale questionnaire
Description
The questionnaire is filled in every week of the 12 week study period
Time Frame
Change in the IBS-specific quality of life score between the subsensory and the OFF period in the crossover study
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 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 and characterised with IBS-D or IBS-M.
Patients who have been treated with sacral nerve stimulation for a minimum of 3 years.
Exclusion Criteria:
Other 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 diseases.
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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Long-term Sacral Nerve Stimulation for Irritable Bowel Syndrome.
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