Subsensory Sacral Nerve Stimulation for Irritable Bowel Syndrome

Status Completed

Clinical Trial 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. 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.

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01948973
Study type	Interventional
Source	University of Aarhus
Contact
Status	Completed
Phase	N/A
Start date	September 2013
Completion date	March 2018

View Details

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