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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00387439 |
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Date of registration:
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12/10/2006 |
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Primary sponsor: |
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Public title:
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ORALIA Trial Medical Treatment vs Anoperineal Physiotherapy for Adult Anal Incontinence.
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Scientific title:
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ORALIA Trial Randomized Controlled Trial of Medical Treatment Alone vs Medical Treatment Associated With Anoperineal Physiotherapy for Adult Anal Incontinence. Assessment of Incontinence Symptoms and Quality of Life. |
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Date of first enrolment:
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October 2006 |
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Target sample size:
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443 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00387439 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
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Countries of recruitment
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France
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Contacts
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Name:
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Henri DAMON, MD |
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Address:
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Telephone:
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00.33.4.72.11.75.16 |
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Email:
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henri.damon@chu-lyon.fr |
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Affiliation:
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Name:
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François MION, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospices Civils de Lyon |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age 18 to 75
- Anal incontinence for more than six months.
- Signed informed consent
- Jorge and Wexner's anal incontinence score > or egal 5
Exclusion Criteria:
- Previous course of anoperineal physiotherapy within the past 6 months
- 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).
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anal Incontinence
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Intervention(s)
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Behavioral: Standard medical treatment
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Behavioral: standard medical treatment + anoperineal physiotherapy.
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Primary Outcome(s)
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The primary outcome variable is the patient's response to the question "How would you grade your symptom": major aggravation; aggravation, no changes, improvement and major improvement and rating of that change on an ordinal scale of -5 to +5. The p
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Secondary Outcome(s)
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Secondary outcomes include patient's symptoms questionnaire, continence score, quality of life questionnaire, stool diary and psychological status. These secondary outcomes are measured at the end of the 4 months treatment period and the end of follow-u
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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