The Clinical Efficacy of Non-steroidal Anti-inflammation Drugs in Patients With Benign Prostatic Hyperplasia
Phase 4
Withdrawn
- Conditions
- Benign Prostatic Hyperplasia
- Interventions
- Registration Number
- NCT00687388
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Non-steroidal Anti-inflammation Drugs can effectively reduce the lower urinary tract symptoms from benign prostatic hyperplasia
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Male
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Alpha-blocker selective alpha 1-blockers Alpha-blocker only NSAID celecoxib NSAID only alpha-blocker and NSAID alpha-blocker and NSAID Combination treatment of alpha-blocker and NSAID
- Primary Outcome Measures
Name Time Method The changes of International Prostatic Symptom Scores after medications 8 weeks
- Secondary Outcome Measures
Name Time Method The changes of voiding frequencies after medications 8 weeks 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 maximum flow rate and postvoid residuals 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
Trial Locations
- Locations (3)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of