benign prostatic hyperplasia
Conditions
Interventions
tadalafil for 6 weeks followed by placebo 6 weeks
tadalafil for 6 weeks following to placebo 6 weeks.
Sponsors
Department of Urology, Kyoto University, Graduate School of Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Patients who agree with this study 2) 50 years old men and elder 3) Diagnosed as benign prostatic hyperplasia using a standard method 4) Prostatic volume is between 20ml and 40ml 5) Patients who have IPSS total score no less than 8 and QOL no less than 3 under treatment of tamsulosin 0.2mg for at least 4 weeks.
Exclusion criteria
Exclusion criteria: 1) Patients with prostate cancer, neurogenic bladder, urethral stricture, chronic prostatitis, urinary tract infections, urinary tract stones or interstitial cystitis. 2) Patients with a contraindication for tadarafil 3) Patients taking silodosin or naftopidil, or in 2 weeks after stopping those two. 4) Patients taking dutasteride, or in 3 months after stopping dutasteride. 5) Patients taking anticholinergics, or in 2 weeks after stopping them. 6) Patients who are diagnosed as not applicable to this study by an attending doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences of total IPSS score from baseline to cross over treatment of tadalafil and placebo for 6 weeks each | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Changes in questionnaire parameters (IPSS-QOL, IIEF) 2) Changes in uroflowmetry parameters (voided volume, Qmax, residual urine) 3) Changes in voiding diary (frequency per day, frequency at daytime, frequency at night, urine volume per day and average voided volume) 4) Safety, adverse events and side effects | — |
Countries
Japan
Contacts
Public ContactHiromitsu Negoro
Kyoto University, Graduate School of Medicine Urology
Outcome results
None listed