Multimodal Stimulation Before and After Sacral Nerve Stimulation for Irritable Bowel Syndrome

May 16, 2018 updated by: University of Aarhus

Evaluation of the Gastro-colic Response in IBS Patients Treated With Sacral Nerve Stimulation

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. The investigators have previously shown IBS patients to benefit from sacral nerves stimulation. With the present study, the investigators aim to evaluate if sacral nerve stimulation alters the gastro-colic response in IBS patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 will be examined with Multimodal Stimulation at baseline and at six weeks in the sacral nerve stimulation test period.

During the Multimodal Stimulation the patients will have impedance planimetry conducted before and after a standardised meal to evaluate on their gastro-colic response without and during sacral nerve stimulation.

The patients enrolled in the study will in the same time period participate in another study evaluating subsensory sacral nerve stimulation. A study registered at clinical trials.

Here 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 stimulation test period of a total of 6 weeks (a permanent electrode is used).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 questionnaire 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: sacral nerve stimulation
A single armed study to evaluate the on the gastro-colic response in IBS patients treated with sacral nerve stimulation
Device: sacral nerve stimulation
Sacral nerve stimulation
Other Names:
  • External pacemaker, model 3625, Medtronic Inc.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cross sectional area
Time Frame: Change from baseline in cross sectional area at 6 weeks of stimulation
Patients will be examined with Multimodal Stimulation using impedance planimetry measuring the cross sectional area before and after a standardised meal at baseline and at 6 weeks of stimulation
Change from baseline in cross sectional area at 6 weeks of stimulation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Wall stiffness
Time Frame: Change from baseline in wall stiffness at 6 weeks of stimulation
Patients will be examined with Multimodal Stimulation using impedance planimetry calculating the wall stiffness before and after a standardised meal at baseline and at 6 weeks of stimulation
Change from baseline in wall stiffness at 6 weeks of stimulation
Compliance
Time Frame: Change from baseline in compliance at 6 weeks of stimulation
Patients will be examined with Multimodal Stimulation using impedance planimetry measuring the compliance before and after a standardised meal at baseline and at 6 weeks of stimulation
Change from baseline in compliance at 6 weeks of stimulation
Cold
Time Frame: Change from baseline in cold tolerance at 6 weeks of stimulation
Patients will be examined with Multimodal Stimulation using impedance planimetry measuring the cold tolerance before and after a standardised meal at baseline and at 6 weeks of stimulation
Change from baseline in cold tolerance at 6 weeks of stimulation
Heat
Time Frame: Change from baseline in heat tolerance at 6 weeks of stimulation
Patients will be examined with Multimodal Stimulation using impedance planimetry measuring the heat tolerance before and after a standardised meal at baseline and at 6 weeks of stimulation
Change from baseline in heat tolerance at 6 weeks of stimulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201302, JLF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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