An interventional study of Biofeedback and Placebo in Incontinence and Constipation, sponsored by University Hospital, Rouen. Terminated at 1 site in France. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-02-16.
Sponsored by University Hospital, Rouen · Not applicable and Interventional
Looking for a modification of the cortical excitability of the motor area corresponding to the external anal sphincter after biofeedback sessions.
Introduction: Nervous control of pelvic floor is not much known. The dysfunction of this musculature, and particularly of the external anal sphincter, is a frequent cause of anal incontinence and/or dyschesia. Biofeedback training is often offered to patients suffering from incontinence or constipation. However, its mechanisms of action is still controversial.
Objective of the study: to compare excitability of the cortical area responsible for control volunteer of the external anal sphincter in healthy subjects before and after 4 biofeedback sessions.
Subjects and methodology: we offer to perform two groups of 12 healthy subjects (one active and one control group) without any neurological or digestive disease and having never performed biofeedback. In each group, cortical excitability will be evaluated by cortical magnetic stimulation (curve intensity/amplitude, silent period, inter-stimulus period, motor threshold) before and after 4 biofeedback sessions (one session by week) in active group or 4 placebo sessions (placebo group).
We hope to show a modification of cortical excitability in subjects performing biofeedback compared to others.
1,040 studies on the registry are indexed under Constipation; 139 are open to participants now.
This study's planned enrollment of 24 is below the median of 78 across 867 interventional studies indexed under Constipation.
Browse Constipation studies →University Hospital, Rouen is the lead sponsor of 416 studies on the registry; 105 are open to participants now.
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Exclusion Criteria:
biofeedback (active group)
Other: Biofeedback
discussion about digestive tract (placebo group)
Other: Placebo
4 sessions of biofeedback one session each week
4 sessions, one each week, of discussion about anorectal disease
external anal sphincter motor threshold silent period double-pulse stimulation: inter-stimulus interval amplitude and duration of external anal sphincter contraction
Time frame: final
This study is terminated, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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