ORALIA Trial Medical Treatment vs Anoperineal Physiotherapy for Adult Anal Incontinence.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00387439|
Recruitment Status : Terminated
First Posted : October 13, 2006
Last Update Posted : September 19, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Anal Incontinence||Behavioral: standard medical treatment + anoperineal physiotherapy. Behavioral: Standard medical treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||173 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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.|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||December 2011|
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.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00387439
|Lyon, France, 69424|
|Principal Investigator:||François MION, MD||Hospices Civils de Lyon|