Subsensory Sacral Nerve Stimulation for Irritable Bowel Syndrome

N/ACompletedNCT01948973

University of Aarhus21 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Irritable Bowel Syndrome

Interventions

SubsensoryDEVICE

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

OFFDEVICE

The stimulation is here turned OFF

SuprasensoryDRUG

The stimulation is here set suprasensory

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Aarhus, Denmark

Outcomes

Primary Outcomes

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

Time frame: Every week during the 6 weeks test period

Secondary Outcomes

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

Time frame: Every week during the 6 weeks test period

Data from ClinicalTrials.gov

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