Benign Prostatic Hyperplasia
Conditions
Interventions
Tadarafil alone 5mg once a day oral administration
Tadarafil + Dutasteride Tadarafil 5mg once a day oral administration Dutasteride 0.5mg once a day oral administration
Sponsors
Department of Urology Uonuma Institute of Community Medicine Niigata University Medical and Dental Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Male aged 50 or higher with prostate volume of 30 ml or higher and IPSS of 8 or higher
Exclusion criteria
Exclusion criteria: 1) Prostate cancer 2) Neurogenic bladder 3) no administration of drugs for overactive bladder and BPH exclude a1-blocker 4) no administration of Dutasteride, Finasteride, anti-androgen, and testosterone within 6 months 5) no administration of PDE5 inhibitors 6) contraindication of Tadarafil 7) contraindication of Dutasteride
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total international prostate symptom score on 12 weeks after administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Total IPSS on 24 weeks after administration IPSS sub-score, OABSS, IIEF5, AMS Score, SF-8, Uroflowmetry, Post-voided residual volume, prostate volume, blood pressure, adverse effect on 4, 12, and 24 weeks | — |
Countries
Japan
Contacts
Public ContactTsutomu Nishiyama
Uonuma Institute of Community Medicine Niigata University Medical and Dental Hospital Department of Urology
Outcome results
None listed