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

NCT00387439 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2013-09-19

No results posted yet for this study

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.

Conditions

  • Anal Incontinence

Interventions

BEHAVIORAL

standard medical treatment + anoperineal physiotherapy.

BEHAVIORAL

Standard medical treatment

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • François MION, MD · Hospices Civils de Lyon

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2011-06-30
Completion
2011-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00387439 on ClinicalTrials.gov