benign prostatic hyperplasia
Conditions
Interventions
Generic Tamsulosin Hydrochloride
Sponsors
NPO MINS
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1)age >= 50 at IC 2)regularly visit will be possible during study period 3)I-PSS is from 8 to 19 4)prostate volume of >= 20mL 5)residual volume <= 150ml 6)written IC
Exclusion criteria
Exclusion criteria: 1) Patients who treated by medicine that has androgenic hormone within 4 weeks before IC. 2) Patients with cases or suspicion of prostatic cancer 3) Patients with suspicion of neurogenic bladder 4) Patients with urethral stricture 5) Patients with chronic bacterial prostatitis or active urinary tract infection 6) Past history of surgery or invasive therapy for BPH. 7) Irradiation for pelvic area within 1 year prior to IC. 8) Patients with any disease that induce dysuria (such as bladder neck contracture or urolithiasis) 9) Patients with cardiovascular disease. 10) Patients with serious disease or impairment of liver, kidney and blood 11) patients who are participated in any clinical studies within 3 months prior to the study 12) Patients who are judged inappropriate for the clinical trial by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| international prostate symptom score : I-PSS QOL score | — |
Secondary
| Measure | Time frame |
|---|---|
| Uroflowmetry (if available at the study site) Safety(vital, labo test, AEs) Drug compliance | — |
Countries
Japan
Contacts
Public ContactShinji Tsukada
NPO MINS Clinical trial supporting center
Outcome results
None listed