Evaluation of the efficacy of topical oestrogen therapy in the management of urinary dysfunction
| ISRCTN | ISRCTN33778440 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33778440 |
| Protocol serial number | G9410491 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- 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
Scientific
Department of Epidemiology and Public Health
University of Leicester
22-28 Princess Road West
Leicester
LE1 2TP
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To 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) studied | Incontinence |
| Intervention | 1. Active: Topical vaginal oestrogen in the form of vaginal slow releasing rings (Estring) 2. Control: Matching placebo |
| Intervention type | Other |
| Primary outcome measure(s) |
Clinical assessment using urinary diaries and 24 hour home pad tests. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/06/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target sample size at registration | 432 |
| Key inclusion criteria | 1. Urinary dysfunction measured clinically (incontinence, nocturia, frequent voiding, urinary urgency) 2. Post-menopausal women |
| Key exclusion criteria | 1. 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 enrolment | 01/09/1999 |
| Date of final enrolment | 01/06/2001 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Epidemiology and Public Health
Leicester
LE1 2TP
United Kingdom
LE1 2TP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
