Clinical trial NCT00687388: The Clinical Efficacy of Non-steroidal Anti-inflammation Drugs in Patients With Benign Prostatic Hyperplasia
Official title: The Clinical Efficacy of Non-steroidal Anti-inflammation Drugs in Patients With Benign Prostatic Hyperplasia: A Prospective Randomized Multicenter Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Benign Prostatic Hyperplasia
Keywords: Cyclooxygenase 2 Inhibitors
Alpha Blockers
Treatment Outcome
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: The Korean Urological Association
First posted: 2008-05-30
Enrollment: 0
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: The changes of International Prostatic Symptom Scores after medications
timeFrame: 8 weeks
Secondary outcomes:
measure: The changes of voiding frequencies after medications
timeFrame: 8 weeks
measure: The changes of 'ICS male questionnaire-short form' after medications
timeFrame: 8 weeks
measure: Patient perception of treatment benefit questionnaire
timeFrame: 8 weeks
measure: The changes of 'patient perception of bladder condition' after medications
timeFrame: 8 weeks
measure: The changes of maximum flow rate and postvoid residuals after medications
timeFrame: 8 weeks
measure: The changes of serum PSA levels after medications
timeFrame: 8 weeks
measure: The changes of WBC counts on the expressed prostatic secretions after medications
timeFrame: 8 weeks
measure: Complications
timeFrame: During all study periods
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Kyu-Sung Lee, Ph.D., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kramer G, Steiner GE, Handisurya A, Stix U, Haitel A, Knerer B, Gessl A, Lee C, Marberger M. Increased expression of lymphocyte-derived cytokines in benign hyperplastic prostate tissue, identification of the producing cell types, and effect of differentially expressed cytokines on stromal cell proliferation. Prostate. 2002 Jun 1;52(1):43-58. doi: 10.1002/pros.10084.
citation: Untergasser G, Madersbacher S, Berger P. Benign prostatic hyperplasia: age-related tissue-remodeling. Exp Gerontol. 2005 Mar;40(3):121-8. doi: 10.1016/j.exger.2004.12.008. Epub 2005 Jan 22.
citation: Lee KL, Peehl DM. Molecular and cellular pathogenesis of benign prostatic hyperplasia. J Urol. 2004 Nov;172(5 Pt 1):1784-91. doi: 10.1097/01.ju.0000133655.71782.14.
citation: Handisurya A, Steiner GE, Stix U, Ecker RC, Pfaffeneder-Mantai S, Langer D, Kramer G, Memaran-Dadgar N, Marberger M. Differential expression of interleukin-15, a pro-inflammatory cytokine and T-cell growth factor, and its receptor in human prostate. Prostate. 2001 Dec 1;49(4):251-62. doi: 10.1002/pros.10020.
citation: Kakehi Y, Segawa T, Wu XX, Kulkarni P, Dhir R, Getzenberg RH. Down-regulation of macrophage inhibitory cytokine-1/prostate derived factor in benign prostatic hyperplasia. Prostate. 2004 Jun 1;59(4):351-6. doi: 10.1002/pros.10365.
citation: Steiner GE, Newman ME, Paikl D, Stix U, Memaran-Dagda N, Lee C, Marberger MJ. Expression and function of pro-inflammatory interleukin IL-17 and IL-17 receptor in normal, benign hyperplastic, and malignant prostate. Prostate. 2003 Aug 1;56(3):171-82. doi: 10.1002/pros.10238.
citation: Wang W, Bergh A, Damber JE. Chronic inflammation in benign prostate hyperplasia is associated with focal upregulation of cyclooxygenase-2, Bcl-2, and cell proliferation in the glandular epithelium. Prostate. 2004 Sep 15;61(1):60-72. doi: 10.1002/pros.20061.
citation: Kramer G, Marberger M. Could inflammation be a key component in the progression of benign prostatic hyperplasia? Curr Opin Urol. 2006 Jan;16(1):25-9.
citation: Rohrmann S, De Marzo AM, Smit E, Giovannucci E, Platz EA. Serum C-reactive protein concentration and lower urinary tract symptoms in older men in the Third National Health and Nutrition Examination Survey (NHANES III). Prostate. 2005 Jan 1;62(1):27-33. doi: 10.1002/pros.20110.
citation: Araki T, Yokoyama T, Kumon H. Effectiveness of a nonsteroidal anti-inflammatory drug for nocturia on patients with benign prostatic hyperplasia: a prospective non-randomized study of loxoprofen sodium 60 mg once daily before sleeping. Acta Med Okayama. 2004 Feb;58(1):45-9. doi: 10.18926/AMO/32115.