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An oestrogen cream for the treatment of faecal incontinence

Are topical oestrogens useful in faecal incontinence? A double blind randomised trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN75311338
Enrollment
34
Registered
2008-05-16
Start date
2006-06-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Faecal incontinence Signs and Symptoms Faecal incontinence

Interventions

Application of topical estriol (Ovestin®) or placebo according to the randomisation. The cream was applied in the anal canal mucosa three times a day (tid) during six weeks. Dosage approximately 1 g e

Sponsors

Pontifical Catholic University of Chile (Pontificia Universidad Catolica de Chile) (Chile)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).

Countries

Chile

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026