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

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.

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00387439

Enrollment

173

Registered

2006-10-13

Start date

2006-10-31

Completion date

2011-12-31

Last updated

2013-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Incontinence

Keywords

Anal incontinence, Gastroenterology, Anoperineal physiotherapy, Randomized clinical trial

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.

Interventions

BEHAVIORALstandard medical treatment + anoperineal physiotherapy.

BEHAVIORALStandard medical treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	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

Measure	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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026