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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
275
UK-369,003 100mg, 50mg, 25mg and 10mg doses in addition to placebo.
Placebo
This is an estimation study with no primary endpoint. There are efficacy endpoints.
Time frame: 12 Weeks
Patient reported treatment impact questionnaire.
Time frame: 12 Weeks
Lower urinary tract symptoms diary.
Time frame: 12 Weeks
International prostate symptom score questionnaire.
Time frame: 12 Weeks
OAB-q short form questionnaire.
Time frame: 12 Weeks
Patient perception of bladder control questionnaire.
Time frame: 12 Weeks
International index of erectile function questionnaire.
Time frame: 12 Weeks
International consultation on incontinence questionnaire.
Time frame: 12 Weeks
Quality of erection questionnaire.
Time frame: 12 Weeks
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Miranda, New South Wales, Australia
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Kippa-Ring, Queensland, Australia
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Victoria, British Columbia, Canada
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Barrie, Ontario, Canada
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Kitchener, Ontario, Canada
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Toronto, Ontario, Canada
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Rancagua, Región del Libertador General Bernardo O’Higgins, Chile
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Santiago, RM, Chile
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Santiago, RM, Chile
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Medellín, Antioquia, Colombia
...and 42 more locations