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

University of Aarhus

Status

Completed

Conditions

Irritable Bowel Syndrome

Treatments

Device: sacral nerve stimulation

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01950715

201302, JLF

Details and patient eligibility

About

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.

Full 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).

Enrollment

21 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No 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 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