Study The Effects Of Different Doses Of UK-369,003 In Men With Overactive Bladder
- Registration Number
- NCT00479505
- Lead Sponsor
- Pfizer
- Brief Summary
This is a 12 week study in which different doses of UK-369,003 will be administered to patients with a diagnosis of overactive bladder. Patients will complete a series of questionnaires before treatment, during treatment and after treatment, to assess whether UK-369,003 has improved their symptoms of overactive bladder and erectile function.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 275
Inclusion Criteria
- Male subjects aged 18 years and above
- documented clinical diagnosis of overactive bladder with urinary frequency >= 8 times / 24 hours and number of urgency episodes > 1 episode / 24 hours.
Exclusion Criteria
- Neurological diseases known to affect bladder function.
- Urinary tract infection.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active UK-369,003 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method This is an estimation study with no primary endpoint. There are efficacy endpoints. 12 Weeks
- Secondary Outcome Measures
Name Time Method Patient reported treatment impact questionnaire. 12 Weeks Lower urinary tract symptoms diary. 12 Weeks International prostate symptom score questionnaire. 12 Weeks OAB-q short form questionnaire. 12 Weeks Patient perception of bladder control questionnaire. 12 Weeks International index of erectile function questionnaire. 12 Weeks International consultation on incontinence questionnaire. 12 Weeks Quality of erection questionnaire. 12 Weeks
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.
What molecular mechanisms does UK-369,003 target to improve storage lower urinary tract symptoms in men with overactive bladder?
How does the efficacy of UK-369,003 compare to anticholinergic medications in treating overactive bladder symptoms in men?
Are there specific biomarkers that can predict response to modified release UK-369,003 in patients with storage LUTS and erectile dysfunction?
What are the potential adverse events associated with UK-369,003 and how do they compare to other bladder modulating agents like beta-3 adrenergic agonists?
What is the therapeutic potential of UK-369,003 in combination with phosphodiesterase-5 inhibitors for men with overactive bladder and erectile dysfunction?
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇬🇧Leeds, United Kingdom
Pfizer Investigational Site🇬🇧Leeds, United Kingdom