ORALIA Trial Medical Treatment vs Anoperineal Physiotherapy for Adult Anal Incontinence.
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 comparison with standard treatment alone.
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.
Behavioral: standard medical treatment + anoperineal physiotherapy.
Behavioral: Standard medical treatment
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||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.|
- 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 [ Time Frame: during the treatment period ] [ Designated as safety issue: No ]
- 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-up [ Time Frame: at the end of the 4 months treatment period and the end of follow-up ] [ Designated as safety issue: No ]
|Study Start Date:||October 2006|
|Study Completion Date:||December 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Experimental: standard medical treatment
standard medical treatment
|Behavioral: Standard medical treatment|
Experimental: standard medical treatment + anoperineal physiotherapy
standard medical treatment + anoperineal physiotherapy
|Behavioral: standard medical treatment + anoperineal physiotherapy.|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00387439
|Lyon, France, 69424|
|Principal Investigator:||François MION, MD||Hospices Civils de Lyon|