An Effectiveness and Safety Study Comparing Oxybutynin Chloride Plus FLOMAX (Tamsulosin HCl) and Placebo Plus FLOMAX (Tamsulosin HCl) for the Treatment of Lower Urinary Tract Symptoms.
An Effectiveness and Safety Study Comparing Oxybutynin Chloride Plus FLOMAX (Tamsulosin HCl) and Placebo Plus FLOMAX (Tamsulosin HCl) for the Treatment of Lower Urinary Tract Symptoms.
The purpose of this study is to evaluate the safety and effectiveness of oxybutynin extended
 release tablets 10 mg plus tamsulosin HCl 0.4 mg in the treatment of lower urinary tract
 symptoms as measured by change of the total International Prostate Symptom Score (I-PSS) from
 baseline to Week 12 or the Final Visit.
The objective of this double-blind (neither the patient nor the physician knows whether drug
 or placebo is being taken, or at what dosage), randomized (patients are assigned different
 treatments based on chance), parallel group trial is to evaluate the safety and effectiveness
 of oxybutynin extended release tablets 10 mg per day for 12 weeks in conjunction with an
 alpha-blocker for the treatment of lower urinary tract symptoms (LUTS). The hypothesis of the
 study is that oxybutynin extended release tablets 10 mg plus tamsulosin 0.4 mg will be more
 effective than tamsulosin 0.4 mg plus placebo in the treatment of lower urinary tract
 symptoms as measured by change of the total International Prostate Symptom Score (I-PSS) from
 baseline to Week 12 or the Final Visit. Safety assessments include Peak Flow Rate (PFR) and
 Post-Void Residual (PVR) volume, adverse events, vital signs and physical exams. Patients
 will receive oxybutynin extended release 10 mg plus tamsulosin 0.4 mg or placebo plus
 tamsulosin 0.4 mg every day for 12 weeks.
Inclusion Criteria:

 -  Diagnosis of lower urinary tract symptoms with urgency and frequency with or without
 urge incontinence

 -  have had at least 4 weeks of 0.4 mg/day tamsulosin therapy

 -  an International Prostate Symptom Score (I-PSS) >=13

 -  irritative component I-PSS score >= 8

 -  max flow >= 8ml/sec with voided volume >= 125 ml, post-void residual volume <= 150 ml
 on two occasions.

 Exclusion Criteria:

 -  Clinically significant medical problems or other organ abnormality or pathology

 -  Prostate-Specific Antigen (PSA) >= 4 ng/ml

 -  history of inability to empty bladder completely or not at all

 -  uncontrolled narrow angle glaucoma

 -  history of any prostate surgery or treatment

 -  history of significant gastrointestinal problems.