Long-term Sacral Nerve Stimulation for Irritable Bowel Syndrome.

Irritable Bowel Syndrome Clinical Trial

Official title:

Long-term Efficacy of Sacral Nerve Stimulation for Irritable Bowel Syndrome. A Randomised Controlled Crossover Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02294760
• Other study ID #: 44418
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

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