Clinical Effect and Safety of Tamsulosin 0.4mg in Patients With LUTS/BPH Refractory to Tamsulosin 0.2mg

Condition(s) targeted: Benign Prostatic Hyperplasia

Intervention: tamsulosin (Drug); placebo (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Samsung Medical Center

Official(s) and/or principal investigator(s):
Sung Won Lee, MD, Principal Investigator, Affiliation: Samsung Medical Center

Overall contact:
Sung Won Lee, MD, Phone: 82-2-3410-3552, Email: drswlee@skku.edu

The purpose of this study is to explore the efficacy and safety of tamsulosin 0. 4mg (Harnal® D. 0. 2mg, 2T) in patients with LUTS/BPH refractory to tamsulosin 0. 2mg (Harnal® D 0. 2mg, 1T).

Official title: Clinical Effect and Safety of Tamsulosin 0.4mg in Patients With LUTS/BPH Refractory to Tamsulosin 0.2mg

Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: To explore the efficacy of tamsulosin 0.4mg (Harnal® D. 0.2mg, 2T)in reducing the score of International Prostate Symptom Score (IPSS) from baseline to 12 weeks of treatment in patients with LUTS/BPH refractory to tamsulosin 0.2mg (Harnal® 0.2mg, 1T)

Secondary outcome: To evaluate efficacy on maximal flow rate and post-voided residual urine To evaluate efficacy on voiding frequency , nocturia To explore the tolerability and safety

Detailed description: Alpha-adrenoreceptor antagonists have become the primary medical treatment for lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). The next treatment method is trans-urethral resection of prostate (TURP). TURP is the most efficient BPH treatment for relieving symptoms and improving uroflow, but it is also the invasive and morbid.

Tamsulosin has higher selectivity for the pharmacological a1-adrenoceptor subtype and the cloned a1a subtype than for the a1b subtype. Tamsulosin 0. 4 mg improved Qmax to a slightly greater extent than alfuzosin 10 mg.(26% and 16% versus baseline, respectively)(http://www. fda. gov/cder/approval/ index. htm;accessed October 27, 2003.) and Tamsulosin 0. 4 mg o. d. has been reported to be well tolerated irrespective of age and/or cardiovascular comorbidity/co-medication (Michel et al 1998) and no interaction with several antihypertensive agents has been reported. (Lowe et al. 1997) Our study is to explore the efficacy and safety of tamsulosin 0. 4mg (Harnal® D. 0. 2mg, 2T) in patients with LUTS/BPH refractory to tamsulosin 0. 2mg (Harnal® D 0. 2mg, 1T).

Minimum age: 45 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Male ≥ 45years

- (LUTS/BPH patients refractory to tamsulosin 0. 2mg during 4 weeks)

*All of the following:

- Moderate to severe LUTS : IPSS ≥ 13

- An enlarged prostate (≥ 20mL, or moderately enlarged)

- Decreased peak flow rate : Qmax ≥4ml/s, ≤15mL/s volume voided ≥ 125 mL)

Exclusion Criteria:

- Post voided residual urine ≥ 200mL

- Patients performing catheterization

- Urinary tract infection patients

- Patients taking 5 alpha reductase inhibitor

- Known hypersensitivity to tamsulosin

- History of postural hypotension or syncope

- Hypertension patients treated with other alpha1-blockers

- Patients newly taking anticholinergic medication within 1 month

- Hepatic insufficiency (AST/ALT ≥ 2 times of normal range)

- Renal insufficiency (s-Cr ≥ 2mg/dL)

Sung Won Lee, MD, Phone: 82-2-3410-3552, Email: drswlee@skku.edu

Department of Urology, Samsung Medical Center, Seoul 135-710, Korea, Republic of

Starting date: August 2009
Last updated: August 6, 2009