Clinical trial NCT01948973: Subsensory Sacral Nerve Stimulation for Irritable Bowel Syndrome
Official title: A Randomised, Controlled Crossover Study of Subsensory Sacral Nerve Stimulation for Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome
Sacral Nerve Stimulation
Symptoms
Quality of Life
Bowel habits
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2013-09-24
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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. 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.

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 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.

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 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

Primary outcomes:
measure: The Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome version questionnaire
timeFrame: Every week during the 6 weeks test period
Secondary outcomes:
measure: Irritable Bowel Syndrome - Impact Scale questionnaire
timeFrame: Every week during the 6 weeks test period
Other outcomes:
measure: Bowel habit diary
timeFrame: Every day during the 6 weeks test period
Locations:
city: Aarhus
country: Denmark
facility: Surgical Research Unit, Department of Surgery P, Aarhus University Hospital
Study officials:
affiliation: Surgical Research Unit, Department of Surgery P, Aarhus University Hospital
name: Janne Fassov, PhD
role: PRINCIPAL_INVESTIGATOR
References: