A randomised, controlled trial to compare the effects of systemic HRT (tibolone) and vaginal oestrogen (estring) upon the overactive bladder in postmenopausal women.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN74263041

Enrollment

120

Registered

2005-09-30

Start date

2003-07-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urological and Genital Diseases: Overactive bladder Urological and Genital Diseases Other disorders of the bladder

Interventions

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 rec

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 120 postmenopausal women aged 60 or over who are suffering from overactive bladder symptoms.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Not provided at time of registration	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026