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

NCT ID: NCT01950715

Last Updated: 2018-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2018-03-31

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. 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.

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).

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

sacral nerve stimulation

A single armed study to evaluate the on the gastro-colic response in IBS patients treated with sacral nerve stimulation

Group Type: OTHER

sacral nerve stimulation

Intervention Type: DEVICE

Sacral nerve stimulation

Interventions

sacral nerve stimulation

Sacral nerve stimulation

Intervention Type: DEVICE

Other Intervention Names

External pacemaker, model 3625, Medtronic Inc.

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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janne Fassov, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Aarhus, , Denmark

Countries

Denmark

Other Identifiers

201302, JLF

Identifier Type: -

Identifier Source: org_study_id