Overactive bladder
Conditions
Interventions
Silodosin (4mg) 1 Capsule or Silodosin (2mg) 2 Capsules 2x1 after breakfast and dinner daily, orally
Propiverine (10mg) 1x1 after breakfast daily, orally
Sponsors
National Center for Geriatrics & Gerontology
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Men are aged 50 or older. 2) Prostate volume is 20ml or greater and less than 30ml by ultrasonography. 3) Overactive bladder is indicated by OABSS: urgency score 2 or greater and total score 5 or greater 4) Postvoid residual urine is 50ml or less.
Exclusion criteria
Exclusion criteria: 1) Primary angle-closure glaucoma 2) Obstructive intestinal disease, paralytic ileus, gastrointerstinal atony, myastania gravis, severe heart disease 3) Cognitive disturbance 4) Active urinary tract infection 5) Past history of bladder and/or prostate surgery 6) Past history of bladder and/or prostate cancer 7) Treatment for benign prostate hyperplasia and/or overactive bladder within 3 months 8) Apparent neurological disease 9) judged as being unsuitable for the trial by the researcher
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who need treatment change or discontinuation within 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| OABSS, I-PSS total score, QoL index, voiding/storage subscore, maximal flow rate, postvoid residual urine volume (PVR), the ratio of patients with increasing PVR and adverse effect | — |
Countries
Japan
Contacts
Public ContactKikuo Okamura
National Center for Geriatrics & Gerontology Division of Urology, Department of Surgery & Intensive Care
Outcome results
None listed