Evaluation of the efficacy of topical oestrogen therapy in the management of urinary dysfunction

ISRCTN ISRCTN33778440
DOI https://doi.org/10.1186/ISRCTN33778440
Secondary identifying numbers G9410491
Submission date
25/10/2000
Registration date
25/10/2000
Last edited
20/07/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
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 C McGrother
Scientific

Department of Epidemiology and Public Health
University of Leicester
22-28 Princess Road West
Leicester
LE1 2TP
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesTo evaluate the effect of topical oestrogen therapy on post-menopausal women with incontinence and bladder storage abnormality symptoms.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedIncontinence
Intervention1. Active: Topical vaginal oestrogen in the form of vaginal slow releasing rings (Estring)
2. Control: Matching placebo
Intervention typeOther
Primary outcome measureClinical assessment using urinary diaries and 24 hour home pad tests.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/09/1999
Completion date01/06/2001

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexFemale
Target number of participants432
Key inclusion criteria1. Urinary dysfunction measured clinically (incontinence, nocturia, frequent voiding, urinary urgency)
2. Post-menopausal women
Key exclusion criteria1. Pregnancy
2. Malignancy
3. Fistula
4. Those already in receipt of treatment
5. Those already on hormone replacement therapy
6. Undiagnosed vaginal bleeding
7. Oestrogen dependent tumour
8. Active thrombo-embolic disease
Date of first enrolment01/09/1999
Date of final enrolment01/06/2001

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Epidemiology and Public Health
Leicester
LE1 2TP
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone +44 (0)20 7636 5422
Email clinical.trial@headoffice.mrc.ac.uk
Website http://www.mrc.ac.uk

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan