Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0013146054
Study information
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.
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised double-blind controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/07/2003
Overall trial end date
01/09/2005
Reason abandoned
Eligibility
Participant inclusion criteria
120 postmenopausal women aged 60 or over who are suffering from overactive bladder symptoms.
Participant type
Patient
Age group
Senior
Gender
Female
Target number of participants
120
Participant 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
Recruitment start date
01/07/2003
Recruitment end date
01/09/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Guy's Hospital
London
SE1 9RT
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Guy's and St. Thomas' NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary