Clinical trial NCT00387439: ORALIA Trial Medical Treatment vs Anoperineal Physiotherapy for Adult Anal Incontinence.
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anal Incontinence
Keywords: Anal incontinence
Gastroenterology
Anoperineal physiotherapy
Randomized clinical trial
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2006-10-13
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.


Eligibility criteria: 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).

Primary outcomes:
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
timeFrame: during the treatment period
Secondary outcomes:
measure: 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
timeFrame: at the end of the 4 months treatment period and the end of follow-up
Other outcomes:
Locations:
city: Lyon
country: France
facility: Anne-Marie SCHOTT
Study officials:
affiliation: Hospices Civils de Lyon
name: François MION, MD
role: PRINCIPAL_INVESTIGATOR
References: