Fecal Incontinence, Regional Cerebral Blood Flow
Conditions
Keywords
Positron emission tomography (PET), Idiopathic Faecal Incontinence, Bilateral Sacral Nerve Stimulation, Sacral Nerve Stimulation, Sacral Nervemodulation
Brief summary
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.
Detailed description
Faecal incontinence is a devastating condition affecting daily living and quality of life. A new treatment Sacral Nerve Stimulation (SNS) has over the last decade given new hope to these patients. In Europe SNS is routinely offered to patients not archiving satisfactory continence result with standard non-surgical treatments. SNS is electrical stimulation of the sacral nerve root(s2,3 or 4). Stimulation of this nerve roots results in improved continence. The mechanism of action is at present not well described. Recent studies have shown that the effect of SNS is by means a neuromodulation in the central nervous system, whereas direct stimulation of efferent nerves to the anal sphincter and the pelvic floor has less significance. The aim of this study is to describe changes in regional cerebral blood flow (RCBF), with positron emission tomography (PET), in patients implanted bilaterally with sacral neuromodulators with the indication idiopathic faecal incontinence. RCBF in three deferent stimulations settings will be compared. PET will be performed before and one hour after changes in the activity status of the pacemakers. Four weeks prior to the first scan, patients are informed to switch both neurostimulator off. PET will be performed with the pacemaker settings: OFF/OFF (Stimulation status of left/right pacemaker), On/Off and On/On. The order of the On/OFF and On/On period will be random. Unilateral stimulation will be performed with the pacemaker there has the best efficacy, determined prior to study enrolment. The interval between these three pacemaker settings is four weeks. Four weeks prior to each PET scan the patients fill in bowel habit diaries, bowel habit questionnaires and quality of life assessments. The association between continence and changes in RCBF will be studied. Additional RCBF and quality of life will be compared.
Interventions
DEVICEMedtronic InterStim II - 3058
Stimulation with optimal pacemaker settings unilateral and bilateral with standard pacemaker settings: Amplitude sensory treshold, frequency 14 Hz and impulsduration 210 μsec.
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Regional Cerebral Blood Flow with different pacemaker settings | 12 weeks after study enrolment | RCBF evaluated with positron emission tomography. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in continence and quality of life with different pacemaker activation. | 12 weeks after study enrolment | Changes in incontinence episodes and quality of life will be correlated to changes in RCBF with different pacemaker activation. |
Countries
Denmark
Outcome results
None listed