Anal IncontinenceNCT00387439
ORALIA Trial Medical Treatment vs Anoperineal Physiotherapy for Adult Anal Incontinence.
A study testing standard medical treatment + anoperineal physiotherapy. and Standard medical treatment in people with Anal Incontinence, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anal Incontinence
- What is being tested?
- standard medical treatment + anoperineal physiotherapy. and Standard medical treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2006to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75
- Anal incontinence for more than six months.
- Signed informed consent
- Jorge and Wexner's anal incontinence score > or egal 5
Who cannot join
- 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,
Show all 11Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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 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.
- Conditions
- Anal Incontinence
- Being tested
- standard medical treatment + anoperineal physiotherapy., Standard medical treatment
- Keywords
- Anal incontinence, Gastroenterology, Anoperineal physiotherapy, Randomized clinical trial
- Medical subject headings
- Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard medical treatment + anoperineal physiotherapy.Behavioural
Standard medical treatmentBehavioural
| Study group | Role | What they receive |
|---|---|---|
| standard medical treatment | Experimental | standard medical treatment Receives: Behavioral: Standard medical treatment |
| standard medical treatment + anoperineal physiotherapy | Experimental | standard medical treatment + anoperineal physiotherapy Receives: Behavioral: standard medical treatment + anoperineal physiotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during the treatment period
Secondary outcomes (1)
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
Measured: at the end of the 4 months treatment period and the end of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionJun 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal IncontinenceStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François MION, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00387439
- Sponsor's protocol ID
- 2006.429
- Status last verified
- Sep 2013
- First submitted
- 12 Oct 2006
- Last updated
- 19 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00387439
- Acronym / sponsor ID
- 2006.429
- Conditions
- Anal Incontinence
- Keywords
- Anal incontinence, Gastroenterology, Anoperineal physiotherapy, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Jun 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 13 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard medical treatment | Experimental | Behavioral: Standard medical treatmentstandard medical treatment |
| standard medical treatment + anoperineal physiotherapy | Experimental | Behavioral: standard medical treatment + anoperineal physiotherapy.standard medical treatment + anoperineal physiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 75
- Anal incontinence for more than six months.
- Signed informed consent
- Jorge and Wexner's anal incontinence score > or egal 5
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard medical treatment + anoperineal physiotherapy. | Behavioural | standard medical treatment + anoperineal physiotherapy |
| Standard medical treatment | Behavioural | standard medical treatment |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François MION, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard medical treatment + anoperineal physiotherapy. and Standard medical treatment in people with Anal Incontinence, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2013.