Benign Prostatic Hyperplasia
Conditions
Keywords
Cyclooxygenase 2 Inhibitors, Alpha Blockers, Treatment Outcome
Brief summary
Non-steroidal Anti-inflammation Drugs can effectively reduce the lower urinary tract symptoms from benign prostatic hyperplasia
Interventions
DRUGselective alpha 1-blockers
Continued medication that the patient had before the enrollment of this study (tamsulosin 0.2mg, alfuzosin 10mg, doxazosin 4, 8mg, or terazosin 2-10mg daily for 8 weeks)
DRUGcelecoxib
200mg daily for 8 weeks
DRUGalpha-blocker and NSAID
amsulosin 0.2mg, alfuzosin 10mg, doxazosin 4, 8mg, or terazosin 2-10mg daily for 8 weeks and celecoxib 200mg daily for 8 weeks
Sponsors
The Korean Urological Association
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The changes of International Prostatic Symptom Scores after medications | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The changes of 'ICS male questionnaire-short form' after medications | 8 weeks |
| Patient perception of treatment benefit questionnaire | 8 weeks |
| The changes of 'patient perception of bladder condition' after medications | 8 weeks |
| The changes of voiding frequencies after medications | 8 weeks |
| The changes of serum PSA levels after medications | 8 weeks |
| The changes of WBC counts on the expressed prostatic secretions after medications | 8 weeks |
| Complications | During all study periods |
| The changes of maximum flow rate and postvoid residuals after medications | 8 weeks |
Countries
South Korea
Outcome results
None listed