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Irritable Bowel Syndrome | Subsensory Sacral Nerve Stimulation for Irritable Bowel Syndrome

Irritable Bowel Syndrome research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Irritable Bowel Syndrome

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:SubsensoryThe stimulation is here set to 90% of the sensory threshold

Device:OFFThe stimulation is here turned OFF

Drug:SuprasensoryThe stimulation is here set suprasensory

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

OFF, subsensory, suprasensoryHere 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, OFF, suprasensoryHere 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.

Study Status

Completed

Start Date: September 2013

Completed Date: March 2018

Phase: N/A

Type: Interventional

Design:

Primary Outcome: The Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome version questionnaire

Secondary Outcome: Irritable Bowel Syndrome - Impact Scale questionnaire

Study sponsors, principal investigator, and references

Principal Investigator: Janne Fassov, PhD

Lead Sponsor: University of Aarhus

Collaborator: Medtronic

More information:https://clinicaltrials.gov/show/NCT01948973

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