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

Samsung Medical Center

Status and phase: Withdrawn; Phase 4

Conditions: Benign Prostatic Hyperplasia

Treatments: Drug: selective alpha 1-blockers; Drug: alpha-blocker and NSAID; Drug: celecoxib

Study type: Interventional

Funder types: Other

Identifiers

NCT00687388

2006-07-084

Details and patient eligibility

About

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

Sex: Male

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Alpha-blocker

Active Comparator group

Description:

Alpha-blocker only

Treatment:

Drug: selective alpha 1-blockers

NSAID

Active Comparator group

Description:

NSAID only

Treatment:

Drug: celecoxib

alpha-blocker and NSAID

Experimental group

Description:

Combination treatment of alpha-blocker and NSAID

Treatment:

Drug: alpha-blocker and NSAID