Clinical efficacy and safety of Naftopidil treatment for the patients with benign prostatic hyperplasia
- Conditions
- Diseases of The genitoruinary system
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 120
Male ambulatory patients over 50 years of age with LUTS (lower urrinary tract symptom) (total IPSS (International prostate symptom score) greater than 8), who completed the informed consent
Allergic drug reaction to a1-AR (adrenoreceptor) antagonists, orthostatic hypotension, a history of prostate-related surgery (open or endoscopic), suspicious prostate malignant condition on digital rectal examination and/or prostate-specific antigen (PSA) > 10 ng/ml, a history of recurrent urinary tract infection or bladder stones, renal impairment (creatinine clearance rate <30 ml/min), severe hepatic disorders, the use of anticholinergic or cholinergic agents, the use of other a1-AR (adrenoreceptor) antagonists (tamsulosin, silodosin, alfuzosin, doxazocin, terazocin) within the previous 4 weeks, or the use of 5-reductase inhibitors or antiandrogens within the previous 3 months. Patients who were currently receiving or were planning to take any a-receptor agonists or ß-receptor antagonists were also excluded.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes from baseline in systolic/diastolic BP (blood pressure) after naftopidil 50mg, 75mg treatment;Changes from baseline in IPSS (interanational prostate symptom score) scores after naftopidil 50mg, 75mg treatment
- Secondary Outcome Measures
Name Time Method AEs (adverse events) after naftopidil 50mg, 75mg treatment;Improvement in IPSS(international prostate symptom score) obstructive/irritative/QoL (quality of life) subscores,Q max (maximum flow rate), and benefit, satisfaction with treatment, and willingness to continue treatment (BSW) questionnaires after naftopidil 50mg, 75mg treatment