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
Secondary identifying numbers N0013146054
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

Academic Dept of Womens Health GKT
HRT Research
Guy's Hospital
St Thomas' Street
London
SE1 9RT
United Kingdom

Study information

Study designRandomised double-blind controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised, controlled trial to compare the effects of systemic HRT (tibolone) and vaginal oestrogen (estring) upon the overactive bladder in postmenopausal women.
Study objectivesTo 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) studiedUrological and Genital Diseases: Overactive bladder
InterventionA 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 typeOther
Primary outcome measurePrimary 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 measuresNot provided at time of registration
Overall study start date01/07/2003
Completion date01/09/2005

Eligibility

Participant type(s)Patient
Age groupSenior
SexFemale
Target number of participants120
Key inclusion criteria120 postmenopausal women aged 60 or over who are suffering from overactive bladder symptoms.
Key exclusion criteria1. 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 enrolment01/07/2003
Date of final enrolment01/09/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Guy's Hospital
London
SE1 9RT
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Guy's and St. Thomas' NHS Foundation Trust (UK)

No information available

NHS R&D Support Funding (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan