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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02294760
Other study ID # 44418
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2014
Est. completion date December 2016

Study information

Verified date May 2018
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Twenty two patients with IBS-D or IBS-M according to the ROME III criteria, will be enrolled by invitation in the study.

Having meet inclusion criteria, the patients are first set subsensory for 4 weeks and then randomised to receive either OFF-subsensory or subsensory-OFF stimulation in a 4+4-week period.

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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Patients who are psychologically stable and suitable for intervention and able to provide informed consent

- Patients who are diagnosed with IBS according to the Rome III criteria and characterised with IBS-D or IBS-M.

- Patients who have been treated with sacral nerve stimulation for a minimum of 3 years.

Exclusion Criteria:

- Other 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 diseases.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Subsensory
The stimulation is set to 90% of the sensory threshold.
OFF
The stimulation is turned OFF.

Locations

Country Name City State
Denmark Surgical Research Unit, Department of Surgery P, Aarhus University Hospital Aarhus

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome version The questionnaire is filled in every week of the 12 week study period Change in the IBS-specific symptom score between the subsensory and the OFF period in the crossover study
Secondary Irritable Bowel Syndrome - Impact Scale questionnaire The questionnaire is filled in every week of the 12 week study period Change in the IBS-specific quality of life score between the subsensory and the OFF period in the crossover study
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