A Study to Measure the Effect of Tolterodine Extended Release on the Thickness of the Bladder Wall in Patients With Overactive Bladder
Phase 4
Completed
- Conditions
- Urinary Incontinence
- Registration Number
- NCT00137397
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
The main aim of the study is to investigate whether taking Tolterodine for overactive bladder symptoms can reduce the thickness of the bladder wall, as measured by intra-vaginal ultrasound. This will help doctors to understand whether there is a link between changes in the thickness of the bladder wall and progression of symptoms.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 80
Inclusion Criteria
- Symptoms of overactive bladder (described as urinary urgency, with or without urge incontinence, usually with frequency and nocturia for more than 6 months
- Bladder wall thickness of 5mm or more
Exclusion Criteria
- Treatment in the previous four weeks with an anticholinergic drug or any drug for the treatment of overactive bladder.
- Significant stress incontinence - Urinary tract infection or a history of intermittent urinary tract infections (more than four episodes in the last two years).
- Conditions considered significant by the investigator (e.g. cystocoele, significant bladder prolapse, bladder stone, indwelling catheter etc)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The main outcome will be the change in bladder wall thickness, as measured by intra-vaginal ultrasound from baseline to week 12.
- Secondary Outcome Measures
Name Time Method Secondary outcomes are the change in bladder wall thickness, as measured by intra-vaginal ultrasound from baseline to week 24
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇬🇧Pl6 8Dh, United Kingdom