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ISRCTN
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ISRCTN74263041
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ClinicalTrials.gov identifier
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Public title
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A randomised, controlled trial to compare the effects of systemic HRT (tibolone) and vaginal oestrogen (estring) upon the overactive bladder in postmenopausal women.
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0013146054
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised double blind controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Urological and Genital Diseases: Overactive bladder
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Participants - inclusion criteria
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120 postmenopausal women aged 60 or over who are suffering from overactive bladder symptoms.
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Participants - exclusion criteria
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1. Women aged < 60yrs
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
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Anticipated start date
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01/07/2003
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Anticipated end date
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01/09/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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120
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Guy's and St. Thomas' NHS Foundation Trust (UK)
NHS R&D Support Funding (UK)
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Trial website
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Publications
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Contact name
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Dr
Surya
Gupta-Wright
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Address
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Academic Dept of Womens Health GKT
HRT Research
Guy's hospital
St Thomas' Street
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City/town
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London
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Zip/Postcode
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SE1 9RT
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Country
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United Kingdom
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Tel
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+44 (0)20 7188 3024
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Email
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Sponsor
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Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2005
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Last edited
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09/07/2009
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Date ISRCTN assigned
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30/09/2005
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