ORALIA Trial Medical Treatment vs Anoperineal Physiotherapy for Adult Anal Incontinence. (NCT00387439) | Clinical Trial Compass
TerminatedNot Applicable
ORALIA Trial Medical Treatment vs Anoperineal Physiotherapy for Adult Anal Incontinence.
France173 participantsStarted 2006-10
Plain-language 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 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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