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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Does Tolterodine ER modulate bladder wall thickness via muscarinic receptor antagonism in overactive bladder patients?
How does Tolterodine ER compare to Oxybutynin in reversing detrusor overactivity and wall thickening in female overactive bladder patients?
Are there specific urodynamic biomarkers that correlate with Tolterodine ER response in patients with overactive bladder and increased bladder wall thickness?
What are the long-term safety and tolerability profiles of Tolterodine ER in reducing bladder wall hypertrophy in overactive bladder patients?
How do anticholinergic agents like Tolterodine ER influence bladder wall remodeling compared to beta-3 adrenergic agonists in treating overactive bladder?
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇬🇧Pl6 8Dh, United Kingdom
Pfizer Investigational Site🇬🇧Pl6 8Dh, United Kingdom