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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00387439
First received: October 12, 2006
Last updated: September 18, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Anal Incontinence
Behavioral: standard medical treatment + anoperineal physiotherapy.
Behavioral: Standard medical treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
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.

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 173
Study Start Date: October 2006
Study Completion Date: December 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: standard medical treatment
standard medical treatment
Behavioral: Standard medical treatment
Experimental: standard medical treatment + anoperineal physiotherapy
standard medical treatment + anoperineal physiotherapy
Behavioral: standard medical treatment + anoperineal physiotherapy.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00387439

Locations
France
Anne-Marie SCHOTT
Lyon, France, 69424
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: François MION, MD Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00387439     History of Changes
Other Study ID Numbers: 2006.429
Study First Received: October 12, 2006
Last Updated: September 18, 2013
Health Authority: France: Ministry of Health

Keywords provided by Hospices Civils de Lyon:
Anal incontinence
Gastroenterology
Anoperineal physiotherapy
Randomized clinical trial

ClinicalTrials.gov processed this record on July 20, 2014