An oestrogen cream for the treatment of faecal incontinence

Completed

• Conditions: Faecal incontinence; Signs and Symptoms

• Registration Number: ISRCTN75311338
• Lead Sponsor: Pontifical Catholic University of Chile (Pontificia Universidad Catolica de Chile) (Chile)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-16
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 34

Inclusion Criteria

1. Post-menopausal women (at least 1 year) without hormonal substitution
2. Aged 69 years ± 8 (treatment group) and 66 years ± 8 (placebo group)
3. Wexner's faecal incontinence (FI) score greater than 5
4. Anal ultrasound with less than 50% damage to external sphincter
5. Accepted informed consent

Exclusion Criteria

1. Perianal lesions
2. History of endometrial, breast or cervix cancer
3. Allergy to oestrogens

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The degree of continence was evaluated by Wexner's FI score at the beginning and end of the protocol (six weeks since the beginning).

Secondary Outcome Measures

Name	Time	Method
In order to evaluate the degree of impact on quality of life, we used a quality of life questionnaire validated and accepted for the Spanish language (ECIF), at the beginning and end of the protocol (six weeks since the beginning).