An interventional study of Medtronic InterStim II - 3058 in Regional Cerebral Blood Flow and Fecal Incontinence, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-04.
Sponsored by University of Aarhus · Not applicable, Interventional, and Basic science
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.
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.
312 studies on the registry are indexed under Fecal Incontinence; 57 are open to participants now.
This study's enrollment of 10 is below the median of 50 across 216 interventional studies indexed under Fecal Incontinence.
Browse Fecal Incontinence studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
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Exclusion Criteria:
Pacemaker status: Bilateral Off for four weeks before first PET scann.
Device: Medtronic InterStim II - 3058
Pacemaker status: Bilateral On. PET scan one hour after activation and after four weeks continuous stimulation.
Device: Medtronic InterStim II - 3058
Pacemaker status: Unilateral On. PET scan one hour after activation and after four weeks continuous stimulation.
Device: Medtronic 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.
Changes in Regional Cerebral Blood Flow with different pacemaker settings
RCBF evaluated with positron emission tomography.
Time frame: 12 weeks after study enrolment
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.
Time frame: 12 weeks after study enrolment
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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University of Aarhus