Long-term Sacral Nerve Stimulation for Irritable Bowel Syndrome.
NCT ID: NCT02294760
Last Updated: 2018-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2014-11-30
2016-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Subsensory, OFF, subsensory
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.
Subsensory
The stimulation is set to 90% of the sensory threshold.
OFF
The stimulation is turned OFF.
Subsensory, subsensory, OFF
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.
Subsensory
The stimulation is set to 90% of the sensory threshold.
OFF
The stimulation is turned OFF.
Interventions
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Subsensory
The stimulation is set to 90% of the sensory threshold.
OFF
The stimulation is turned OFF.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
60 Years
ALL
No
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Janne Fassov, PhD
Role: PRINCIPAL_INVESTIGATOR
Surgical Research Unit, Department of Surgery P, Aarhus University Hospital
Locations
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Surgical Research Unit, Department of Surgery P, Aarhus University Hospital
Aarhus, , Denmark
Countries
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Other Identifiers
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44418
Identifier Type: -
Identifier Source: org_study_id
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