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.
A Multi-Center, Randomised, Parallel Group, Double-Blind, Placebo Controlled Estimation Study To Assess The Efficacy And Safety Of Modified Release UK-369,003 In The Treatment Of Men With Storage Lower Urinary Tract Symptoms (LUTS) With And Without Erectile Dysfunction (ED).
Overactive Urinary Bladder
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measures:
- This is an estimation study with no primary endpoint. There are efficacy endpoints.
Secondary Outcome Measures:
- Lower urinary tract symptoms diary.
- International prostate symptom score questionnaire.
- OAB-q short form questionnaire.
- Patient perception of bladder control questionnaire.
- International index of erectile function questionnaire.
- International consultation on incontinence questionnaire.
- Quality of erection questionnaire.
- Patient reported treatment impact questionnaire.
Eligibility & Criteria
- Ages Eligible for Study: 18 Years and above
- Genders Eligible for Study: Male
- 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.
- Neurological diseases known to affect bladder function.
- Urinary tract infection.
- Miranda, New South Wales, 2228, Australia
- Kippa Ring, Queensland, 4021, Australia
For more information, contact Pfizer
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