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| Sponsors and Collaborators: |
University Hospital, Rouen Coloplast A/S |
|---|---|
| Information provided by: | University Hospital, Rouen |
| ClinicalTrials.gov Identifier: | NCT00653887 |
Purpose
Looking for a modification of the cortical excitability of the motor area corresponding to the external anal sphincter after biofeedback sessions.
| Condition | Intervention |
|---|---|
|
Incontinence Constipation |
Other: Biofeedback Other: Placebo |
| Study Type: | Interventional |
| Study Design: | Randomized, Single Blind (Caregiver), Placebo Control, Parallel Assignment |
| Official Title: | Modifications of the Anal Muscle Cortical Excitability Area After Biofeedback Training |
| Estimated Enrollment: | 24 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | April 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Active Comparator
biofeedback (active group)
|
Other: Biofeedback
4 sessions of biofeedback one session each week
|
|
B: Placebo Comparator
discussion about digestive tract (placebo group)
|
Other: Placebo
4 sessions, one each week, of discussion about anorectal disease
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Anne-Marie LEROI, PhD | 00-33-2-32-88-80-39 | anne-marie.leroi@chu-rouen.fr |
| France | |
| Physiology Unit - Rouen university Hospital | Recruiting |
| rouen, France, 76031 | |
| Principal Investigator: Anne-marie leroi, PhD | |
| Principal Investigator: | Anne-Marie LEROI, PhD | CHU Rouen |
More Information
| Responsible Party: | Physiology unit ( Leroi ) |
| Study ID Numbers: | 2007/054HP, 2007- A00652-51 |
| Study First Received: | April 2, 2008 |
| Last Updated: | April 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00653887 |
| Health Authority: | France: Direction Générale de la Santé |
|
Biofeedback anal sphincter cortical excitability |
magnetic stimulation incontinence constipation |
|
Signs and Symptoms Urologic Diseases Signs and Symptoms, Digestive |
Urination Disorders Constipation Urinary Incontinence |
|
Urological Manifestations |
