A randomised, controlled trial to compare the effects of systemic HRT (tibolone) and vaginal oestrogen (estring) upon the overactive bladder in postmenopausal women.
| ISRCTN | ISRCTN74263041 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74263041 |
| Protocol serial number | N0013146054 |
| Sponsor | Department of Health |
| Funders | Guy's and St. Thomas' NHS Foundation Trust (UK), NHS R&D Support Funding (UK) |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 08/09/2015
- 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 Surya Gupta-Wright
Scientific
Scientific
Academic Dept of Womens Health GKT
HRT Research
Guy's Hospital
St Thomas' Street
London
SE1 9RT
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised, controlled trial to compare the effects of systemic HRT (tibolone) and vaginal oestrogen (estring) upon the overactive bladder in postmenopausal women. |
| Study objectives | To ascertain if symptoms and markers of an overactive bladder can be improved by the use of topical or systemic hormone replacement therapy (HRT) in postmenopausal women. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Urological and Genital Diseases: Overactive bladder |
| Intervention | A double-blind randomised study, patients will be randomised to systemic HRT (tibolone) and placebo rings, 40 will receive placebo tablets and oestradiol releasing vaginal rings (estring), 40 will receive placebo tablets and placebo rings. Women will be followed up for one year and will be required to make 7 visits in total. The women will be provided with an information leaflet regarding the study and be given the opportunity to ask any questions before written consent is obtained. Prior to inclusion, the women will have a medical history recorded, blood pressure measured and a urine sample tested by dipstick to exclude the presence of a urinary tract infection. A positive result for blood, nitrites or protein will require further investigation. Baseline measurements of quality of life questionnaire, transvaginal ultrasound scan to assess bladder wall thickness, urine flow rate and residual urine volume and completion of a urinary symptom diary will be recorded prior to random allocation of treatment. Subjects will be followed for one year, attending the clinic every 3 months. |
| Intervention type | Other |
| Primary outcome measure(s) |
Primary outcome will be quality of life assessed using the Kings Health Questionnaire (KHQ). Objective measures will include symptom diaries for 48 hours, bladder wall thickness and urine dipstick. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Female |
| Target sample size at registration | 120 |
| Key inclusion criteria | 120 postmenopausal women aged 60 or over who are suffering from overactive bladder symptoms. |
| Key exclusion criteria | 1. Women aged < 60 years 2. Pre-menopausal women 3. Women who have had a history of uncontrolled metabolic diseases, neurological conditions, permanent catheterisation, chronic urinary tract infections 4. Patients who have any contraindications to the use of HRT 5. Patients who have suffered a major prolapse (as defined by The International Continence Society) 6. Patients who have taken hormone replacement therapy within the last 6 months |
| Date of first enrolment | 01/07/2003 |
| Date of final enrolment | 01/09/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Guy's Hospital
London
SE1 9RT
United Kingdom
SE1 9RT
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
