ORALIA Trial Medical Treatment vs Anoperineal Physiotherapy for Adult Anal Incontinence.

Study Overview
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Brief Summary
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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.

Official 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.

Conditions
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Anal Incontinence

Intervention / Treatment
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* Behavioral: standard medical treatment + anoperineal physiotherapy.
* Behavioral: Standard medical treatment


Participation Criteria
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Eligibility 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: standard medical treatment<br>standard medical treatment | Behavioral: Standard medical treatment<br> <br> |
| Experimental: standard medical treatment + anoperineal physiotherapy<br>standard medical treatment + anoperineal physiotherapy | Behavioral: standard medical treatment + anoperineal physiotherapy.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | during the treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | at the end of the 4 months treatment period and the end of follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anal incontinence, Gastroenterology, Anoperineal physiotherapy, Randomized clinical trial