Subsensory Sacral Nerve Stimulation for Irritable Bowel Syndrome

• Sponsor: University of Aarhus (Other)
• Overall Status: Completed
• CT.gov ID: NCT01948973
• Collaborator: Medtronic (Industry)
• Enrollment: 21
• Location: 1
• Arms: 2
• Duration (Months): 53.9
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Irritable Bowel Syndrome	Device: Subsensory; Device: OFF; Drug: Suprasensory	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomised, Controlled Crossover Study of Subsensory Sacral Nerve Stimulation for Irritable Bowel Syndrome
• Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Mar 1, 2018
• Actual Study Completion Date: Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: OFF, subsensory, suprasensory Here the stimulator is turned OFF for the first 2 weeks, then set subsensory (90% of sensory threshold) for the next 2 weeks and finally set suprasensory for the last 2 weeks.	Device: Subsensory; The stimulation is here set to 90% of the sensory threshold; Other Names: Device: External pacemaker, model 3625, Medtronic Inc. ; Device: OFF; The stimulation is here turned OFF; Other Names: Device: External pacemaker, model 3625, Medtronic Inc. ; Drug: Suprasensory; The stimulation is here set suprasensory; Other Names: Device: External pacemaker, model 3625, Medtronic Inc.
Active Comparator: Subsensory, OFF, suprasensory Here the stimulator is set subsensory (90% of sensory threshold), then turned OFF for the next 2 weeks and finally set suprasensory in the last 2 weeks.	Device: Subsensory; The stimulation is here set to 90% of the sensory threshold; Other Names: Device: External pacemaker, model 3625, Medtronic Inc. ; Device: OFF; The stimulation is here turned OFF; Other Names: Device: External pacemaker, model 3625, Medtronic Inc. ; Drug: Suprasensory; The stimulation is here set suprasensory; Other Names: Device: External pacemaker, model 3625, Medtronic Inc.

Outcome Measures

Primary Outcome Measures

1. The Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome version questionnaire [Every week during the 6 weeks test period]

   The GRSRS-IBS questionnaire is filled in every week during the test period allowing comparison between OFF, subsensory and suprasensory stimulation

Secondary Outcome Measures

1. Irritable Bowel Syndrome - Impact Scale questionnaire [Every week during the 6 weeks test period]

   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

Other Outcome Measures

1. Bowel habit diary [Every day during the 6 weeks test period]

   The bowel habit diary is filled in every day during the test period allowing comparison between OFF, subsensory and suprasensory stimulation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Surgical Research Unit, Department of Surgery P, Aarhus University Hospital	Aarhus		Denmark	8000

Sponsors and Collaborators

• University of Aarhus
• Medtronic

Investigators

• Principal Investigator: Janne Fassov, PhD, Surgical Research Unit, Department of Surgery P, Aarhus University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT01948973
• Other Study ID Numbers: 1-10-72-170-13, JLF; 1-10-72-170-13
• First Posted: Sep 24, 2013
• Last Update Posted: May 17, 2018
• Last Verified: May 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by University of Aarhus: Irritable Bowel Syndrome; Sacral Nerve Stimulation; Symptoms; Quality of Life; Bowel habits
• Additional relevant MeSH terms: Irritable Bowel Syndrome; Syndrome

Study Results

No Results Posted as of May 17, 2018