Patient description: The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative

Clinical trial eligibility criteria: eligible ages (years): 18.0-999.0,  Lower Urinary Tract Symptoms Adult women, 18 years of age or older, currently diagnosed with LUTS with a significant component of voiding symptoms The Patient must be diagnosed with one of the following: hesitancy, intermittency, difficulty in bladder emptying, or straining to void Patients must have had an AUA Symptom Score of 13 or higher Obstruction component of AUA Symptom Score (Items 1, 3, 5, and 6) had to be 5 points or higher Patients that are currently taking alpha-blockers or anticholinergics must discontinue the drugs at least 2 weeks prior to Visit 1 Patients should show compliance of greater than or equal to 80% with placebo usage Patients should be surgically sterile, or 2 years postmenopausal, or practicing a medically acceptable method of birth control Patients must have a negative urine Beta Human Chorionic Gonadotropin (beta-HCG) Patients must be able to provide written informed consent prior to participation in the study in accordance with regulatory requirements Patients must be judged by the investigator to be reliable and should comply with all tests and examinations stipulated in the protocol  Patients who presented with an active urinary tract infection or who had presented with two or more culture positive urinary tract infections within 6 months of the study Patients with significant prolapse beyond the hymenal ring, per the investigator's judgment Patients who had taken anticholinergic medications for the treatment of other urologic conditions and had not discontinued their use 2 weeks prior to study entry Patients who had a history or active condition of renal or urethral calculi, urethral colic, mechanical outlet obstruction (i.e., bladder neck contracture or stricture, bladder tumor, or bladder calculi) 3 months prior to study entry Patients with a history of bladder, vaginal or urethral surgery in the last 6 months Patients who have a history of microscopic hematuria and not had a recent work-up including cystoscopy and upper urinary tract study (within 6 months of screening) or a diagnosis of a condition that may the patient in the opinion of the investigator Abnormal urinalysis as defined by the following mid-stream, clean-catch specimen results A bacterial colony count of greater than 100,000/ml More than 10 leukocytes per high power field with more than two granular casts per high power field More than 10 red blood cells (non-menstrual tainted urine sample) per high power field