The effect of oestrogen replacement therapy on urinary tract dysfunction and urogenital collagen structure in postmenopausal women with stress incontinence
| ISRCTN | ISRCTN06344732 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06344732 |
| Secondary identifying numbers | R/03/16-12-94/JACKSON/D |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 15/12/2008
- 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
Plain English Summary
Not provided at time of registration
Contact information
Mr Simon Jackson
Scientific
Scientific
North Bristol NHS Trust
Bristol Urological Institute
Department of Urology Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
| Phone | +44 (0)117 9595690 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study hypothesis | To investigate the effect of hormone replacement therapy on post-menopausal urinary stress incontinence. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Urological and genital diseases: Incontinence |
| Intervention | 1. Six months therapy with oestradiol valerate 2 mg daily 2. Placebo |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/08/1995 |
| Overall study end date | 31/07/1996 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target number of participants | Added December 2008: 37 |
| Participant inclusion criteria | Post-menopausal women with genuine stress incontinence, not taking hormone replacement therapy |
| 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
- England
- United Kingdom
Study participating centre
North Bristol NHS Trust
Bristol
BS10 5NB
United Kingdom
BS10 5NB
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive South West (UK)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/1999 | Yes | No |
