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 |
| Protocol serial number | R/03/16-12-94/JACKSON/D |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive South West (UK) |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To investigate the effect of hormone replacement therapy on post-menopausal urinary stress incontinence. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Urological and genital diseases: Incontinence |
| Intervention | 1. Six months therapy with oestradiol valerate 2 mg daily 2. Placebo |
| Intervention type | Other |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/07/1996 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target sample size at registration | 67 |
| Key inclusion criteria | Post-menopausal women with genuine stress incontinence, not taking hormone replacement therapy |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/08/1995 |
| Date of final enrolment | 31/07/1996 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
North Bristol NHS Trust
Bristol
BS10 5NB
United Kingdom
BS10 5NB
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/1999 | Yes | No |
