Long-term Sacral Nerve Stimulation for Irritable Bowel Syndrome.

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

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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Device: Subsensory; Device: OFF

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Surgical Research Unit, Department of Surgery P, Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Subsensory, OFF, subsensory; The stimulator is set subsensory for the first 4 weeks (90% of sensory threshold), then turned OFF for the next 4 weeks and finally set subsensory for the last 4 weeks.	Device: Subsensory; The stimulation is set to 90% of the sensory threshold.; Other Names: Device: External pacemaker, model 3625, Medtronic Inc.; Device: OFF; The stimulation is turned OFF.; Other Names: Device: External pacemaker, model 3625, Medtronic Inc.
Active Comparator: Subsensory, subsensory, OFF; The stimulator is set subsensory for the first 4 weeks (90% of sensory threshold), then set subsensory for another 4 weeks and finally turned OFF for the last 4 weeks.	Device: Subsensory; The stimulation is set to 90% of the sensory threshold.; Other Names: Device: External pacemaker, model 3625, Medtronic Inc.; Device: OFF; The stimulation is turned OFF.; Other Names: Device: External pacemaker, model 3625, Medtronic Inc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Aarhus

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: November 10, 2014
• First Submitted That Met QC Criteria: November 14, 2014
• First Posted (Estimate): November 19, 2014

Study Record Updates

• Last Update Posted (Actual): May 17, 2018
• Last Update Submitted That Met QC Criteria: May 16, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Irritable Bowel Syndrome; Quality of Life; Symptoms; Sacral Nerve Stimulation
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: 44418

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED