Subsensory Sacral Nerve Stimulation for Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:

A Randomised, Controlled Crossover Study of Subsensory Sacral Nerve Stimulation for Irritable Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01948973
• Other study ID #: 1-10-72-170-13, JLF
• Secondary ID: 1-10-72-170-13
• 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. 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.

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.

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 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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Device:
• Subsensory
The stimulation is here set to 90% of the sensory threshold
• OFF
The stimulation is here turned OFF

Drug:
• Suprasensory
The stimulation is here set suprasensory

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
Other	Bowel habit diary	The bowel habit diary is filled in every day during the test period allowing comparison between OFF, subsensory and suprasensory stimulation	Every day during the 6 weeks test period
Primary	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	Every week during the 6 weeks test period
Secondary	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	Every week during the 6 weeks test period