Fecal Incontinence Clinical Trial
Official title:
Cerebral Responses During Bilateral/Unilateral Sacral Nerve Stimulation for Idiopathic Faecal Incontinence - Assessed With Positron Emission Tomography Scan (PET-scan)
The purpose of this study is to determine whether Sacral Nerve Stimulation (SNS) for idiopathic faecal incontinence affect cortical and deep brain activity in an acute and chronically stimulation model. Furthermore the association between brain activity and unilateral/bilateral SNS will be studied in each patient. Brain activity will be studied by use of positron emission tomography.
Status | Completed |
Enrollment | 10 |
Est. completion date | July 2014 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 18 years or older - Informed consent - Idiopathic fecal incontinence or Fecal incontinence due to small sphincter defect(=60 o) - Permanent neuromodulator (medtronic InterStim II) bilateral implanted - Reduction in fecal incontinence episodes of at least 50% between baseline and latest follow up with unilateral stimulation(Bowel diary card) - Willing and competent to fill out diary cards - MR-cerebrum before implantatation of neuromodulator - Right-handed dominant Exclusion Criteria: - Colorectal/proctological surgery since IPG-implant - Pregnancy - Neurological diseases including spinal cord injury. - Use of medication with known alternation of gastrointestinal motilitet (thyroid, diabetes, neuroleptica) - Claustrofobia - Latex allergy |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Denmark | Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital | Aarhus | Aarhus C |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in Regional Cerebral Blood Flow with different pacemaker settings | RCBF evaluated with positron emission tomography. | 12 weeks after study enrolment | No |
Secondary | Changes in continence and quality of life with different pacemaker activation. | Changes in incontinence episodes and quality of life will be correlated to changes in RCBF with different pacemaker activation. | 12 weeks after study enrolment | No |
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