NCT02294760

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 19, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 17, 2018

Status Verified

May 1, 2018

Enrollment Period

2.1 years

First QC Date

November 10, 2014

Last Update Submit

May 16, 2018

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel SyndromeSacral Nerve StimulationSymptomsQuality of Life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Irritable Bowel Syndrome - Impact Scale questionnaire

    Change in the IBS-specific quality of life score between the subsensory and the OFF period in the crossover study

Study Arms (2)

Subsensory, OFF, subsensory

ACTIVE COMPARATOR

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: SubsensoryDevice: OFF

Subsensory, subsensory, OFF

ACTIVE COMPARATOR

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: SubsensoryDevice: OFF

Interventions

SubsensoryDEVICE

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

Also known as: Device: External pacemaker, model 3625, Medtronic Inc.
Subsensory, OFF, subsensorySubsensory, subsensory, OFF
OFFDEVICE

The stimulation is turned OFF.

Also known as: Device: External pacemaker, model 3625, Medtronic Inc.
Subsensory, OFF, subsensorySubsensory, subsensory, OFF

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Surgical Research Unit, Department of Surgery P, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Janne Fassov, PhD

    Surgical Research Unit, Department of Surgery P, Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2014

First Posted

November 19, 2014

Study Start

November 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

May 17, 2018

Record last verified: 2018-05

Locations

DK(1)