Condition category
Urological and Genital Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
08/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Surya Gupta-Wright

ORCID ID

Contact details

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

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 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes