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

Not Applicable

Terminated

• Conditions: Anal Incontinence
• Interventions: Behavioral: Standard medical treatment; Behavioral: standard medical treatment + anoperineal physiotherapy.

• Registration Number: NCT00387439
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-10-12
• Study First Submitted QC: 2006-10-12
• Study First Posted: 2006-10-13
• Primary Completion: 2011-06
• Study Completion: 2011-12
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-18
• Last Update Posted: 2013-09-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 173

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard medical treatment	Standard medical treatment	standard medical treatment
standard medical treatment + anoperineal physiotherapy	standard medical treatment + anoperineal physiotherapy.	standard medical treatment + anoperineal physiotherapy

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Anne-Marie SCHOTT; 🇫🇷 Lyon, France