benign prostatic hypertrophy
Conditions
Interventions
Imidafenacin 0.1mg will be orally administered twice a day,once after breakfast and dinner for 52 weeks. Dutasteride 0.5mg will be orally administered once a day,once after breakfast for 52 weeks.
Dut
Sponsors
Clinical Research Support Center Kyushu
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Patients who have the following criteria in overactive bladder symptom score (OABSS) even after administering Tamsulosin for more than 8 weeks Urgency score >= 2 Total score >=3 2) Aged >=50 years and <90 years 3) Prostate volume >=30mL 4) Patients who are able to give informed consent. 5) Patients from whom we have received written consent.
Exclusion criteria
Exclusion criteria: 1) Patients with a history of hypersensitivity to Tamsulosin, Dutasteride or Imidafenacin 2) Patients who have administered prohibited substances in the 2 weeks prior to randomization (6 months for 5ARIsand/or anti-androgenics) 3) Patients who have done prohibited therapy in the 8 weeks prior to randomization 4) History or current condition of urinary retention or severe difficulty of urination 5) Patients with cancer in the part of lower urinary tract such as prostate or bladder, neurogenic bladder, urethra stricture, chronic prostatitis, symptomatic urinary tract infection, urinary tract stones and interstitial cystitis 6) Patients with serious cardiac disorder, serious liver dysfunction and serious kidney dysfunction 7) Patients with orthostatic hypotension 8) Patients with pyloristenosis, constriction of dodecadactylon, construction of enteron and adynamic ileus 9) Patients with deterioration of enterokinesis 10) Patients with narrow-angle glaucoma 11) Patients with myasthenia gravis 12) Qmax <5 mL/s 13) Residual urine volume >100 mL 14) Serum PSA >10 ng/mL 15) Patients with Polyuria 16) Any other patients who are regarded as unsuitable for this study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of total OABSS score | — |
Countries
Japan
Contacts
Public ContactTomonori Yamanishi
Dokkyo Medical University Department of Urology and Neurology, Continence Center
Outcome results
None listed