Condition category
Signs and Symptoms
Date applied
22/01/2008
Date assigned
16/05/2008
Last edited
16/05/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr George Pinedo

ORCID ID

Contact details

Marcoleta 350 patio interior
Santiago
8330033
Chile

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

Study hypothesis

A topical application of oestrogens is effective for the symptoms of faecal incontinence in post-menopausal women.

Ethics approval

Ethics approval received from the Comite de etica Pontificia Universidad Catolica de Chile on the 3rd April 2007 (ref: C.E. #095/07).

Study design

Double blind, randomised, placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Estriol (Ovestin®)

Primary outcome measures

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 trial start date

01/06/2006

Overall trial end date

01/07/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

34 patients

Participant exclusion criteria

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

Recruitment start date

01/06/2006

Recruitment end date

01/07/2007

Locations

Countries of recruitment

Chile

Trial participating centre

Marcoleta 350 patio interior
Santiago
8330033
Chile

Sponsor information

Organisation

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

Sponsor details

Departamento de Cirugia Digestiva
Marcoleta 350 patio interior
Santiago
8330033
Chile

Sponsor type

University/education

Website

http://www.puc.cl/

Funders

Funder type

University/education

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes