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

Sponsor

Samsung Medical Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00687388

Collaborator

The Korean Urological Association (Other)

Enrollment

Locations

Arms

Patients Per Site

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia	Drug: selective alpha 1-blockers Drug: celecoxib Drug: alpha-blocker and NSAID	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2008

Anticipated Primary Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Alpha-blocker Alpha-blocker only	Drug: selective 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) Other Names: tamsulosin alfuzosin doxazosin terazosin
Active Comparator: NSAID NSAID only	Drug: celecoxib 200mg daily for 8 weeks
Experimental: alpha-blocker and NSAID Combination treatment of alpha-blocker and NSAID	Drug: alpha-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 Other Names: tamsulosin and celecoxib alfuzosin and celecoxib doxazosin and celecoxib terazosin and celecoxib

Arm

Intervention/Treatment

Active Comparator: Alpha-blocker

Alpha-blocker only

Drug: selective 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)

Other Names:

tamsulosin

alfuzosin

doxazosin

terazosin

Active Comparator: NSAID

NSAID only

Drug: celecoxib

200mg daily for 8 weeks

Experimental: alpha-blocker and NSAID

Combination treatment of alpha-blocker and NSAID

Drug: alpha-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

Other Names:

tamsulosin and celecoxib

alfuzosin and celecoxib

doxazosin and celecoxib

terazosin and celecoxib

Outcome Measures

Primary Outcome Measures

The changes of International Prostatic Symptom Scores after medications [8 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Severance Hospital	Seoul	Korea, Republic of	120-752
2	Samsung Medical Center	Seoul	Korea, Republic of	135-710
3	Asan Medical Center	Seoul	Korea, Republic of	138-736