Status:
TERMINATED
ORALIA Trial Medical Treatment vs Anoperineal Physiotherapy for Adult Anal Incontinence.
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Anal Incontinence
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the impact of anoperineal physiotherapy in adjunction to standard medical treatment on symptoms and quality of life of adults with anal incontinence, in compar...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT00387439
Start Date
October 1 2006
End Date
December 1 2011
Last Update
September 19 2013
Active Locations (1)
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1
Anne-Marie SCHOTT
Lyon, France, 69424