The Clinical Efficacy of Non-steroidal Anti-inflammation Drugs in Patients With Benign Prostatic Hyperplasia

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

Non-steroidal Anti-inflammation Drugs can effectively reduce the lower urinary tract symptoms from benign prostatic hyperplasia

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Collaborator: The Korean Urological Association
• Treatments: Adrenergic alpha-Antagonists; Alfuzosin; Anti-Inflammatory Agents, Non-Steroidal; Celecoxib; Doxazosin; Prazosin; Tamsulosin; Terazosin

Criteria

Inclusion Criteria:

• Who had the treatment of BPH with alpha-1 blockers for more than 3 months

• Who have the IPSS(International Prostatic Symptom Score) >= 15

• Who have the maximum flow rate(Qmax) < 15 with voided volume > 150mL

• Who have the PPBC(patient's perception of bladder condition) >= 3 (The PPBC was assessed by the use of a six point ordered categorical scale(1-6 point). The higher score means the higher bother)

• Who had the PSA level < 4 ng/mL within 6 months (But, the patient who are revealed not to have prostate cancer by prostate biopsy can be included even if he had PSA level of 4-10 ng/mL)

• Who underwent the transrectal ultrasound of prostate within 6 months

• Who can understand this study and can give the informed consent

Exclusion Criteria:

• Who had regular intake of 5-alpha reductase inhibitor or NSAID within 6 months before screening

• Who have peptic ulcer and/or asthma

• Who have urologic malignancies such as prostate cancer and bladder cancer

• Who have urethral strictures, large bladder diverticuli, and bladder neck contractures

• Who had surgical treatment for BPH

• Who have histories of bladder and/or urethra

• Who have serum PSA level more than 10 ng/ml

• Who have histories of orthostatic hypotension

• Who have serum creatinine level more than 2.0 mg/dl

• Who have serum ALT and/or AST level more than 1.5 times of normal upper limit

• Who have heart failure

• Who have histories of bacterial prostatitis within 1 year

• Who have histories of active urinary tract infection within 1 month

• Who have histories of the biopsy of bladder and prostate within 1 month

• Who are unable to void

• Who use pads because of incontinences

• Who have hypersensitivities for alpha blockers that include quinazoline, NSAID, aspirin, sulfonamide

• Who have histories of unstable angina, myocardial infarction, and cerebrovascular accident within 6 months

• Who have neurogenic bladder due to multiple sclerosis, Parkinson's disease, Spinal injuries and etc.

• Who have thinking disturbances

• Who have histories of abuses of alcohol and/or other drugs

• Who seem to be not fit to this study by the decision of investigators