An oestrogen cream for the treatment of faecal incontinence

ISRCTN	ISRCTN75311338
DOI	https://doi.org/10.1186/ISRCTN75311338
Secondary identifying numbers	N/A

Submission date: 22/01/2008
Registration date: 16/05/2008
Last edited: 16/05/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr George Pinedo
Scientific

Marcoleta 350 patio interior
Santiago
8330033
Chile

Study information

Study design	Double blind, randomised, placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Are topical oestrogens useful in faecal incontinence? A double blind randomised trial
Study objectives	A topical application of oestrogens is effective for the symptoms of faecal incontinence in post-menopausal women.
Ethics approval(s)	Ethics approval received from the Comite de etica Pontificia Universidad Catolica de Chile on the 3rd April 2007 (ref: C.E. #095/07).
Health condition(s) or problem(s) studied	Faecal incontinence
Intervention	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 every eight hours. The total duration of follow-up of all patients was six weeks.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Estriol (Ovestin®)
Primary outcome measure	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	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).
Overall study start date	01/06/2006
Completion date	01/07/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	34 patients
Key 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
Key exclusion criteria	1. Perianal lesions 2. History of endometrial, breast or cervix cancer 3. Allergy to oestrogens
Date of first enrolment	01/06/2006
Date of final enrolment	01/07/2007

Locations

Countries of recruitment

Chile

Study participating centre

Marcoleta 350 patio interior

Santiago
8330033
Chile

Sponsor information

Pontifical Catholic University of Chile (Pontificia Universidad Catolica de Chile) (Chile)
University/education

Departamento de Cirugia Digestiva
Marcoleta 350 patio interior
Santiago
8330033
Chile

Website	http://www.puc.cl/
"ROR"	https://ror.org/04teye511

Funders

Funder type

University/education

Pontifical Catholic University of Chile (Pontificia Universidad Catolica de Chile) (Chile) - Department of Digestive Surgery (Departamento de Cirugia Digestiva)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan