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

Condition(s) targeted: Benign Prostatic Hyperplasia

Intervention: selective alpha 1-blockers (Drug); celecoxib (Drug); alpha-blocker and NSAID (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Samsung Medical Center

Official(s) and/or principal investigator(s):
Kyu-Sung Lee, Ph.D., M.D., Principal Investigator, Affiliation: Samsung Medical Center

Overall contact:
Kyu-Sung Lee, Ph.D., M.D., Phone: 82-2-3410-3559, Email: ksleedr@skku.edu

Non-steroidal Anti-inflammation Drugs can effectively reduce the lower urinary tract symptoms from 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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The changes of International Prostatic Symptom Scores after medications

Secondary outcome:

The changes of voiding frequencies after medications

The changes of 'ICS male questionnaire-short form' after medications

Patient perception of treatment benefit questionnaire

The changes of 'patient perception of bladder condition' after medications

The changes of maximum flow rate and postvoid residuals after medications

The changes of serum PSA levels after medications

The changes of WBC counts on the expressed prostatic secretions after medications

Complications

Minimum age: 50 Years. Maximum age: 80 Years. Gender(s): Male.

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

Kyu-Sung Lee, Ph.D., M.D., Phone: 82-2-3410-3559, Email: ksleedr@skku.edu

Samsung Medical Center, Seoul 135-710, Korea, Republic of; Recruiting
Kyu-Sung Lee, Email: ksleedr@skku.edu
Kyu-Sung Lee, Ph.D., M.D., Principal Investigator
Deok Hyun Han, M.D., Sub-Investigator

Asan Medical Center, Seoul 138-736, Korea, Republic of; Not yet recruiting
Myung-Soo Choo, Ph.D., M.D., Email: mschoo@amc.seoul.kr
Myung-Soo Choo, Ph.D., M.D., Principal Investigator

Severance Hospital, Seoul 120-752, Korea, Republic of; Not yet recruiting
Jang Hwan Kim, Ph.D., M.D., Email: jkim@yuhs.ac
Jang Hwan Kim, Ph.D., M.D., Principal Investigator

Related publications:

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.

Untergasser G, Madersbacher S, Berger P. Benign prostatic hyperplasia: age-related tissue-remodeling. Exp Gerontol. 2005 Mar;40(3):121-8. Epub 2005 Jan 22. Review.

Lee KL, Peehl DM. Molecular and cellular pathogenesis of benign prostatic hyperplasia. J Urol. 2004 Nov;172(5 Pt 1):1784-91. Review.

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.

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.

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.

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.

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. Review.

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.

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.

Starting date: May 2008
Last updated: December 14, 2011