Subsensory Sacral Nerve Stimulation for Irritable Bowel Syndrome
NCT ID: NCT01948973
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
21 participants
INTERVENTIONAL
2013-09-30
2018-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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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.
Subsensory
The stimulation is here set to 90% of the sensory threshold
OFF
The stimulation is here turned OFF
Suprasensory
The stimulation is here set suprasensory
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.
Subsensory
The stimulation is here set to 90% of the sensory threshold
OFF
The stimulation is here turned OFF
Suprasensory
The stimulation is here set suprasensory
Interventions
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Subsensory
The stimulation is here set to 90% of the sensory threshold
OFF
The stimulation is here turned OFF
Suprasensory
The stimulation is here set suprasensory
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
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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References
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Fassov J, Hoyer KL, Lundby L, Laurberg S, Scott SM, Krogh K. Long-term efficacy and safety of sacral neuromodulation for diarrhoea-predominant and mixed irritable bowel syndrome. Tech Coloproctol. 2025 Jan 4;29(1):41. doi: 10.1007/s10151-024-03066-3.
Other Identifiers
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1-10-72-170-13
Identifier Type: OTHER
Identifier Source: secondary_id
1-10-72-170-13, JLF
Identifier Type: -
Identifier Source: org_study_id
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