Back to results

Subsensory Sacral Nerve Stimulation for Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Subsensory

OFF

Suprasensory

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome, Sacral Nerve Stimulation, Symptoms, Quality of Life, Bowel habits

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients aged over 18
Patients who are psychologically stable and suitable for intervention and able to provide informed consent.
Patients who are diagnosed with IBS-D or IBS-M according to the Rome III criteria
Minimum average of 40 points in the symptom quistionnaire evaluated at baseline

Exclusion Criteria:

Overt 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 disease

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

OFF, subsensory, suprasensory

Subsensory, OFF, suprasensory

Arm Description

Here the stimulator is turned OFF for the first 2 weeks, then set subsensory (90% of sensory threshold) for the next 2 weeks and finally set suprasensory for the last 2 weeks.

Here the stimulator is set subsensory (90% of sensory threshold), then turned OFF for the next 2 weeks and finally set suprasensory in the last 2 weeks.

Outcomes

Primary Outcome Measures

The Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome version questionnaire

The GRSRS-IBS questionnaire is filled in every week during the test period allowing comparison between OFF, subsensory and suprasensory stimulation

Secondary Outcome Measures

Irritable Bowel Syndrome - Impact Scale questionnaire

The IBS-IS questionnaire is filled in every week during the test period allowing comparison of quality of life between OFF, subsensory and suprasensory stimulation

Full Information

NCT ID

NCT01948973

First Posted

September 11, 2013

Last Updated

May 16, 2018

Sponsor

University of Aarhus

Collaborators

Medtronic

1. Study Identification

Unique Protocol Identification Number

NCT01948973

Brief Title

Subsensory Sacral Nerve Stimulation for Irritable Bowel Syndrome

Official Title

A Randomised, Controlled Crossover Study of Subsensory Sacral Nerve Stimulation for Irritable Bowel Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

March 2018 (Actual)

Study Completion Date

March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Aarhus

Collaborators

Medtronic

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Sacral nerve stimulation (SNS) has become a well-established treatment for patients with fecal incontinence since 1995. The mechanism of action of SNS is still not fully understood but recent studies have shown changes in both colonic motility and rectal sensibility. We have previously shown IBS patients to benefit from sacral nerves stimulation. With the present study, we aim to evaluate if subsensory sacral nerve stimulation is as effective as suprasensory sacral nerve stimulation.

Detailed Description

Twenty four patients with IBS-D or IBS-M according to the ROME III criteria, will be enrolled in the study. Having meet inclusion criteria, the patients are randomised to receive either OFF-subsensory or subsensory-OFF stimulation in a 2+2-week period followed by 2 weeks of suprasensory stimulation. Hereby rendering a percutaneous nerve evaluation (PNE) test of a total of 6 weeks. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome, Sacral Nerve Stimulation, Symptoms, Quality of Life, Bowel habits

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OFF, subsensory, suprasensory

Arm Type

Active Comparator

Arm Description

Here the stimulator is turned OFF for the first 2 weeks, then set subsensory (90% of sensory threshold) for the next 2 weeks and finally set suprasensory for the last 2 weeks.

Arm Title

Subsensory, OFF, suprasensory

Arm Type

Active Comparator

Arm Description

Here the stimulator is set subsensory (90% of sensory threshold), then turned OFF for the next 2 weeks and finally set suprasensory in the last 2 weeks.

Intervention Type

Device

Intervention Name(s)

Subsensory

Other Intervention Name(s)

Device: External pacemaker, model 3625, Medtronic Inc.

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

OFF

Other Intervention Name(s)

Device: External pacemaker, model 3625, Medtronic Inc.

Intervention Description

The stimulation is here turned OFF

Intervention Type

Drug

Intervention Name(s)

Suprasensory

Other Intervention Name(s)

Device: External pacemaker, model 3625, Medtronic Inc.

Intervention Description

The stimulation is here set suprasensory

Primary Outcome Measure Information:

Title

The Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome version questionnaire

Description

The GRSRS-IBS questionnaire is filled in every week during the test period allowing comparison between OFF, subsensory and suprasensory stimulation

Time Frame

Every week during the 6 weeks test period

Secondary Outcome Measure Information:

Title

Irritable Bowel Syndrome - Impact Scale questionnaire

Description

The IBS-IS questionnaire is filled in every week during the test period allowing comparison of quality of life between OFF, subsensory and suprasensory stimulation

Time Frame

Every week during the 6 weeks test period

Other Pre-specified Outcome Measures:

Title

Bowel habit diary

Description

The bowel habit diary is filled in every day during the test period allowing comparison between OFF, subsensory and suprasensory stimulation

Time Frame

Every day during the 6 weeks test period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients aged over 18 Patients who are psychologically stable and suitable for intervention and able to provide informed consent. Patients who are diagnosed with IBS-D or IBS-M according to the Rome III criteria Minimum average of 40 points in the symptom quistionnaire evaluated at baseline Exclusion Criteria: Overt 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 disease

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janne Fassov, PhD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Aarhus

ZIP/Postal Code

8000

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Subsensory Sacral Nerve Stimulation for Irritable Bowel Syndrome

We'll reach out to this number within 24 hrs