FLOMAX® Versus Placebo, in Male Patients With Acute Urinary Retention Related to Benign Prostatic Hyperplasia (BPH)

Study Overview
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Brief Summary
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To establish whether the administration of FLOMAX® improves the outcome of a trial without catheter (TWOC) after an episode of acute urinary retention and to determine whether spontaneous voiding is maintained over the course of six months of active treatment

Official Title
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A Two Phase, Double-blinded, Randomized, Parallel Group Design, Multicenter Study of FLOMAX® Capsules, 0.4 mg Versus Placebo, in Male Patients With Acute Urinary Retention Related to Benign Prostatic Hyperplasia

Conditions
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Prostate Hyperplasia

Intervention / Treatment
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* Drug: FLOMAX® capsules
* Drug: Placebo capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Phase I Adult men, 45 years of age or older, diagnosed with acute urinary retention due to BPH Patients who have never taken alpha-blockers or discontinued taking alpha-blockers 72 hours or more prior to entrance into this study Patients that have been treated with an indwelling urethral catheter as treatment for acute urinary retention (AUR) due to BPH Patients must be judged by the investigator to be reliable and willing to comply with all tests and examinations stipulated in the protocol All patients must be willing to give meaningful, written, informed consent prior to participation in the trial, in accordance with regulatory requirements. Patients must also have sufficient understanding to communicate effectively with the investigator Phase II - Patients who voided spontaneously, at least 100 mL and a post-void residual volume of ≤ 300 mL, at Visit 2 Exclusion Criteria: Phase I Patients diagnosed with a symptomatic/active urinary tract infection (UTI) or an abnormal urine culture at baseline or 2 or more UTIs within the last six months. An abnormal urine culture was defined as: A bacterial colony count of greater than or equal to 100,000 CFU/mL or A bacterial colony count of greater than or equal to 100 CFU/mL of a known urinary pathogen in a symptomatic patient Patients that have a distended bladder volume greater than 1.5 liters (1500 ml) of retention as measured by initial catheter urine volume Patients with history of sexually transmitted disease within last two years Patients with active genital herpes disease whose urinary function was impacted due to the disease Patients who have a history of mechanical outlet obstruction excluding BPH (i.e., bladder neck contracture or stricture, bladder tumor, or bladder calculi) Patients with urethral stricture disease Patients with a history of bladder, prostate, or urethral surgery in the last three months Patients presenting with AUR who were not been seen within 5 days of urethral catheter placement Patients presenting with any of the following: active urinary stone disease, previous pelvic radiotherapy, perirectal inflammatory disorders or inflammatory bowel disease Participation in another drug study within 30 days of Visit 1 Clinically relevant conditions which may interfere with the patient's ability to participate in the study including, but not limited to, the following: neurologic, gastrointestinal, cardiovascular, hepatic, renal, psychiatric, hematologic or respiratory disease and clinically relevant laboratory abnormalities not mentioned above (e.g., hematuria) based upon the clinical judgment of the investigator Patients receiving cimetidine, ranitidine or warfarin within two weeks of study start date and who would potentially use such medications during the course of the trial Patients currently treated with finasteride (PROSCAR®) and who would not discontinue its use upon entrance into the study Patients with known hypersensitivity to FLOMAX® (tamsulosin hydrochloride) or other alpha-blockers Patients with a history of myocardial infarction within six months of baseline Patients with uncontrolled hypertension (systolic > 160 mmHg, diastolic > 100 mmHg) and patients with severe hypotension (systolic < 90 mmHg) Patients who have been using the following drugs, 72 hours prior to study start date, or who are unable to discontinue these drugs over the course of the study: Alpha-adrenergic medication Drugs with systemic anticholinergic activity including antihistamines. The following antihistamines are allowed: ALLEGRA®, CLARITIN® or ZYRTEX® Antispasmodics or muscle relaxants Parasympathomimetics, cholinomimetics or similar drug Patients that have poorly controlled diabetes mellitus who suffer from peripheral neuropathy or diabetic cystopathy Patients who suffer from neurological diseases affecting the bladder (i.e., multiple sclerosis, Parkinson's disease, stroke, and any bladder trauma that may be an exclusion criterion in the opinion of the investigator Patients with a neurological impairment or psychiatric disorder that prevents their comprehension of the informed consent and/or the ability to comply with the protocol Patients with a urine volume at the initial catheterization less than 300 mL Patients with a diagnosis of active cancer, except basal cell carcinoma, within 5 years or less Patients who had a transurethral resection of the prostate (TURP) within 5 years or less of study enrollment and irreversible urethral damage due to the procedure Phase II - Patients with clinically, significant abnormal lab results including any baseline laboratory serum test with the following values: Hemoglobin < 11.0 g/dL Leukocytes < 3,000 per mm3 Liver enzymes [aspartate aminotransferase (SGOT), alanine transaminase (SGPT) and alkaline phosphatase]: more than two times the upper limit of normal at baseline Serum creatinine more than two times the upper limit of normal at Visit 1 Patients with clot retention, persistent gross hematuria (Visit 3 only), prostatitis, a symptomatic/active urinary tract infection (UTI) or an abnormal baseline urine culture An abnormal urine culture was defined as: A bacterial colony count of greater than or equal to 100,000 colony forming units (CFU)/mL or A bacterial colony count of greater than or equal to 100 CFU/mL of a kown urinary pathogen in a symptomatic patient

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FLOMAX®<br> | Drug: FLOMAX® capsules<br> <br> * Other names: Tamsulosin hydrochloride;|
| Placebo Comparator: Placebo<br> | Drug: Placebo capsules<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful spontaneous voiding after urethral catheter removal | For Phase I of the trial | Up to 96 hours after start of treatment | 
| Maintenance of successful spontaneous voiding | For Phase II of the trial | Up to 6 months after start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in voided urine volume |  | Up to 6 months after start of treatment | 
| Determination of post-void residual urine volume | by ultrasound or bladder scan | Up to 6 months after start of treatment | 
| Time to recurrence of AUR | For phase II of the trial | Up to 6 months after start of treatment | 
| Clinically significant changes from baseline in vital signs |  | Pre-dose, up to 6 months after start of treatment | 
| Number of patients with adverse events |  | Up to 6 months |