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

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

Official Title
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The Clinical Efficacy of Non-steroidal Anti-inflammation Drugs in Patients With Benign Prostatic Hyperplasia: A Prospective Randomized Multicenter Trial

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Drug: selective alpha 1-blockers
* Drug: celecoxib
* Drug: alpha-blocker and NSAID


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Alpha-blocker<br>Alpha-blocker only | Drug: selective alpha 1-blockers<br>* 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)<br>* Other names: terazosin;|
| Active Comparator: NSAID<br>NSAID only | Drug: celecoxib<br>* 200mg daily for 8 weeks<br>|
| Experimental: alpha-blocker and NSAID<br>Combination treatment of alpha-blocker and NSAID | Drug: alpha-blocker and NSAID<br>* amsulosin 0.2mg, alfuzosin 10mg, doxazosin 4, 8mg, or terazosin 2-10mg daily for 8 weeks and celecoxib 200mg daily for 8 weeks<br>* Other names: terazosin and celecoxib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes of International Prostatic Symptom Scores after medications |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cyclooxygenase 2 Inhibitors, Alpha Blockers, Treatment Outcome