Status:
WITHDRAWN
The Clinical Efficacy of Non-steroidal Anti-inflammation Drugs in Patients With Benign Prostatic Hyperplasia
Lead Sponsor:
Samsung Medical Center
Collaborating Sponsors:
The Korean Urological Association
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
50-80 years
Phase:
PHASE4
Brief Summary
Non-steroidal Anti-inflammation Drugs can effectively reduce the lower urinary tract symptoms from benign prostatic hyperplasia
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00687388
Start Date
May 1 2008
Last Update
June 10 2013
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Severance Hospital
Seoul, South Korea, 120-752
2
Samsung Medical Center
Seoul, South Korea, 135-710
3
Asan Medical Center
Seoul, South Korea, 138-736