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Long-term Sacral Nerve Stimulation for Irritable Bowel Syndrome.

NCT02294760 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2018-05-17

No results posted yet for this study

Summary

A recent randomised, controlled, crossover study has shown that sacral nerve stimulation (SNS) significantly reduces symptoms and improves quality of life of highly selected patients with irritable bowel syndrome (IBS). Relief of IBS symptoms during SNS is associated with consistent changes in rectal sensitivity and biomechanical wall properties.

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.

Conditions

  • Irritable Bowel Syndrome

Interventions

DEVICE

Subsensory

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

DEVICE

OFF

The stimulation is turned OFF.

Sponsors & Collaborators

  • 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
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Denmark

Study Locations

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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 NCT02294760 on ClinicalTrials.gov