Status:
COMPLETED
The Long Term Effects of Alfuzosin(Xatral XL) in Lower Urinary Tract Symptoms(LUTS)/BPH Patients
Lead Sponsor:
Asan Medical Center
Conditions:
BPH
Eligibility:
MALE
50+ years
Phase:
PHASE4
Brief Summary
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 cli...
Detailed Description
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 co...
Eligibility Criteria
Inclusion
- Ambulatory males (≥50 years) suffering from LUTS suggestive of BPH
- Patients satisfying all of the following:
- Moderate to severe LUTS :
- international prostate symptom score (IPSS)≥ 8
- An enlarged prostate (≥25 mL)
- Decreased peak flow rate : Qmax ≤15 mL/s (volume voided ≥ 120 mL)
Exclusion
- Post voided residual urine ≥ 200 mL
- 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 (Aspartate transaminase /alanine aminotransferase ≥ 2 times of normal range)
- Renal insufficiency (s-Cr ≥ 2mg/dL)
- Unstable angina pectoris
- Uninvestigated hematuria
- Serum Prostate specific antigen ≥ 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT00696761
Start Date
May 1 2006
End Date
August 1 2008
Last Update
February 17 2021
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