Status:
COMPLETED
Evaluation of Symptom-specific Goal Achievement
Lead Sponsor:
Samsung Medical Center
Conditions:
Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Eligibility:
MALE
50+ years
Phase:
PHASE4
Brief Summary
Lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) consists of a constellation of symptoms (including voiding, storage, and post-micturition). The impact of the LUTS o...
Eligibility Criteria
Inclusion
- males ≥50 years with LUTS secondary to BPH
- Moderate to severe LUTS : IPSS ≥ 8
- An enlarged prostate : TRUS ≥25 mL
- Decreased peak flow rate : Qmax ≤15mL/s (volume voided ≥ 120 mL)
- Having signed the informed consent to participate in the study.
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00836823
Start Date
December 1 2005
End Date
August 1 2008
Last Update
November 1 2023
Active Locations (2)
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1
Asan Medical Center, Ulsan College of Medicine
Seoul, South Korea
2
Samsung Medical Center
Seoul, South Korea