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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01950715
• Other study ID #: 201302, JLF
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: March 2018

Study information

• Verified date: May 2018
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Device:
• sacral nerve stimulation
Sacral nerve stimulation

Locations

Country	Name	City	State
Denmark	Surgical Research Unit, Department of Surgery P, Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Medtronic

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cross sectional area	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	Wall stiffness	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
Secondary	Compliance	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
Secondary	Cold	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
Secondary	Heat	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