ORALIA Trial Medical Treatment vs Anoperineal Physiotherapy for Adult Anal Incontinence.
NCT ID: NCT00387439
Last Updated: 2013-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
173 participants
INTERVENTIONAL
2006-10-31
2011-12-31
Brief Summary
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A total of 443 patients will be randomized to 2 groups: standard care (medical treatment) alone or standard care associated with anoperineal physiotherapy. Outcome measures include the patient own view of the effectiveness of the treatment, the continence score, quality of life and psychological status. These outcomes are measured at the end of the 4 months treatment period.
Following this period, the non responders to standard medical treatment will be proposed to undergo a course of anoperineal physiotherapy and the non responders to anoperineal physiotherapy will be treated by transcutaneous electrical nerve stimulation (TENS). The outcomes will be measured at the end of the 4 months new treatment and again after 4 months follow-up.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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standard medical treatment
standard medical treatment
Standard medical treatment
standard medical treatment + anoperineal physiotherapy
standard medical treatment + anoperineal physiotherapy
standard medical treatment + anoperineal physiotherapy.
Interventions
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standard medical treatment + anoperineal physiotherapy.
Standard medical treatment
Eligibility Criteria
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Inclusion Criteria
* Anal incontinence for more than six months.
* Signed informed consent
* Jorge and Wexner's anal incontinence score \> or egal 5
Exclusion Criteria
* Anorectal or perineal surgery within the past 6 months.
* Indication for anoperineal surgery
* Vaginal delivery within the past 6 months
* Pregnancy
* Major neurological disease,
* Significant cognitive impairment, dementia or institutionalised.
* Active inflammatory bowel disease.
* Current treatment by sacral nerve neurostimulation.
* Cardiac pacemaker
* Skin damages preventing transcutaneous electrical nerve stimulation (TENS).
18 Years
75 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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François MION, MD
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
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Anne-Marie SCHOTT
Lyon, , France
Countries
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Other Identifiers
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2006.429
Identifier Type: -
Identifier Source: org_study_id