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

Anal Incontinence Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00387439
• Other study ID #: 2006.429
• Status: Terminated
• Phase: N/A
• First received: October 12, 2006
• Last updated: September 18, 2013
• Start date: October 2006
• Est. completion date: December 2011

Study information

• Verified date: September 2013
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 173
• Est. completion date: December 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Anal Incontinence
• Fecal Incontinence

Intervention

Behavioral:
• standard medical treatment + anoperineal physiotherapy.

• Standard medical treatment

Locations

Country	Name	City	State
France	Anne-Marie SCHOTT	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No