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

Civil Hospices of Lyon

Status: Terminated

Conditions: Anal Incontinence

Treatments: Behavioral: Standard medical treatment; Behavioral: standard medical treatment + anoperineal physiotherapy.

Study type: Interventional

Funder types: Other

Identifiers

NCT00387439

2006.429

Details and patient eligibility

About

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.

Enrollment: 173 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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).

Trial design

173 participants in 2 patient groups

standard medical treatment

Experimental group

Description:

standard medical treatment

Treatment:

Behavioral: Standard medical treatment

standard medical treatment + anoperineal physiotherapy

Experimental group

Description:

standard medical treatment + anoperineal physiotherapy

Treatment:

Behavioral: standard medical treatment + anoperineal physiotherapy.