Study The Effects Of Different Doses Of UK-369,003 In Men With Overactive Bladder.

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.

Official Title

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).

Conditions

Overactive Urinary Bladder

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

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.

Study Start

July 2007

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Male

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.

Total Enrolment

300

Contact Details

• Miranda, New South Wales, 2228, Australia
• Kippa Ring, Queensland, 4021, Australia

For more information, contact Pfizer