Official Title: “The Long Term Effects of Alfuzosin(Xatral XL) in LUTS/BPH Patients: Evaluation of Voiding and Storage Function According to Bladder Outlet Obstruction Grade and Bladder Contractility”

Benign prostatic hyperplasia (BPH) is a common condition among older men. The efficacy of α1-blockers for treating BPH has been well documented and they are recommended for the treatment of BPH by clinical guidelines.

It is not well known if a stratification based on the grade of BOO and bladder contractility has any predictive value for patients who are treated with an α1-selective blocking agent. In our study, we investigated possible differences in treatment outcome between patients with and without BOO, and with or without proper contractility who are treated with alfuzosin. So we will compare the quantified improvements 12 months after alfuzosin medication in LUTS/BPH patients by the grade of BOO and/or bladder contractility.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

Study Primary Completion Date: August 2008

1. Primary objective To evaluate efficacy on voiding and storage symptoms in LUTS/BPH patients after 12 months of treatment with Xatral XL® by the grade of bladder outlet obstruction and/or bladder contractility

2. Secondary objectives To evaluate efficacy on voiding and storage symptoms in LUTS/BPH patients after 3 months and 6 months of treatment with Xatral XL® by the grade of bladder outlet obstruction and/or bladder contractility To evaluate efficacy on maximal flow rate (MFR) and post-voided residual urine (PVR) To evaluate on voiding frequency, urgency severity & frequency, and nocturia To evaluate patient tolerability to the medication To evaluate global impression of improvement (GII)

Intervention(s) in this Clinical Trial

• Drug: alfuzosin
  • 10mg, once daily, 12months
• Drug: alfuzosin
  • 10mg, once daily, 12months
• Drug: alfuzosin
  • 10mg, once daily, 12 months
• Drug: alfuzosin
  • 10mg, once daily, 12months

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: group1
  • BOOI≥ 20, BCI≥ 100
• Active Comparator: group2
  • BOOI≥ 20, BCI<100
• Active Comparator: group 3
  • BOOI<20, BCI≥ 100)
• Active Comparator: group 4
  • BOOI<20, BCI<100

Primary Measures

• Primary outcome; IPSS changes between 4 groups compared to baseline after 12 mo treatment
  • Time Frame: 12months
    Safety Issue?: No

Secondary Measures

• Changes of ICS-male questionnaire, uroflowmetry, residual urine volume, and Patient's Global Impression of Improvement
  • Time Frame: 3month, 6month, 12month
    Safety Issue?: No

Inclusion Criteria:

• Ambulatory males (≥50 years) suffering from LUTS suggestive of BPH
• Patients satisfying all of the following:
• Moderate to severe LUTS :
• IPSS ≥ 8
• An enlarged prostate (≥25 mL)
• Decreased peak flow rate : Qmax ≤15mL/s (volume voided ≥ 120 mL)

Exclusion Criteria:

• Post voided residual urine ≥ 200mL
• Patients performing catheterization
• Urinary tract infection patients
• Patients taking 5 alpha reductase inhibitor
• Known hypersensitivity to alfuzosin
• History of postural hypotension or syncope
• Hypertension patients treated with other alpha1-blockers
• Patients newly taking anticholinergic medication within 1 month
• Hepatic insufficiency (AST/ALT ≥ 2 times of normal range)
• Renal insufficiency (s-Cr ≥ 2mg/dL)
• Unstable angina pectoris
• Uninvestigated hematuria
• Serum PSA ≥ 4 ng/mL (biopsy proven no cancer patients can be included)
• Interstitial cystitis patients
• Severe concomitant condition threatening life.
• Patient who is unable to make voiding diary
• Bladder or prostate cancer patients
• Patients receiving prostate or bladder surgery

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Asan Medical Center

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00696761

Study ID Number: L9990

ClinicalTrials.gov Identifier: NCT00696761

Health Authority: Korea: Food and Drug Administration