Condition category
Urological and Genital Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
15/12/2008
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

Mr Simon Jackson

ORCID ID

Contact details

North Bristol NHS Trust
Bristol Urological Institute
Department of Urology Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
+44 (0)117 9595690

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

R/03/16-12-94/JACKSON/D

Study information

Scientific title

Acronym

Study hypothesis

To investigate the effect of hormone replacement therapy on post-menopausal urinary stress incontinence.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Urological and genital diseases: Incontinence

Intervention

1. Six months therapy with oestradiol valerate 2 mg daily
2. Placebo

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Assessment prior to treatment and upon study completion with the SF-36 health status questionnaire, the Bristol Female Lower Urinary Tract Symptoms questionnaire, a one week urinary diary, one hour perineal pad test, cystometry and urethral profilometry.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/08/1995

Overall trial end date

31/07/1996

Reason abandoned

Eligibility

Participant inclusion criteria

Post-menopausal women with genuine stress incontinence, not taking hormone replacement therapy

Participant type

Patient

Age group

Not Specified

Gender

Female

Target number of participants

Added December 2008: 37

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/08/1995

Recruitment end date

31/07/1996

Locations

Countries of recruitment

United Kingdom

Trial participating centre

North Bristol NHS Trust
Bristol
BS10 5NB
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive South West (UK)

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

1999 results in http://www.ncbi.nlm.nih.gov/pubmed/10428529

Publication citations

  1. Results

    Jackson S, Shepherd A, Brookes S, Abrams P, The effect of oestrogen supplementation on post-menopausal urinary stress incontinence: a double-blind placebo-controlled trial., Br J Obstet Gynaecol, 1999, 106, 7, 711-718.

Additional files

Editorial Notes