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Subsensory Sacral Nerve Stimulation for Irritable Bowel Syndrome

NCT01948973 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2018-05-17

No results posted yet for this study

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.

Conditions

  • Irritable Bowel Syndrome

Interventions

DEVICE

Subsensory

The stimulation is here set to 90% of the sensory threshold

DEVICE

OFF

The stimulation is here turned OFF

DRUG

Suprasensory

The stimulation is here set suprasensory

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Janne Fassov, PhD · Surgical Research Unit, Department of Surgery P, Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • Denmark

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01948973 on ClinicalTrials.gov