Clinical efficacy and safety of Naftopidil treatment for the patients with benign prostatic hyperplasia

Clinical efficacy and safety of Naftopidil treatment for the patients with benign prostatic hyperplasia: A prospective, open-label, observational study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002241

Enrollment

120

Registered

2017-02-22

Start date

2014-09-02

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : The enrolled patients suffered from LUTS (lower urinary tract symptom) and were considered fit for a1-AR (adrenoreceptor) antagonist treatment based on the decision of our physician. Patients

90 mmHg in a sitting position) or hypertensive group (HT, diastolic BP=90 mmHg in a sitting position) and then randomly assigned by computer-generated random numbers into the naftopidil 50 mg group or

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactMun Su Chung

Catholic Kwandong University International St.Mary's Hospital

skidms@naver.com+82-32-290-3072

Outcome results