benign prostate hyperplasia with overactive bladder
Conditions
Interventions
tadalafil 5mg monotherapy (12 weeks)
tadalafil 5mg and solifenacin 5mg combined therapy (12 weeks)
Sponsors
Department of Urology, Kyorin University School of Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. male patients aged 45 or older 2. patients with lower urinary tract symptoms (IPSS: 13 points or more) 3. patients with overactive bladder (OABSS: Q3 2 points or more and total score 3 points or more) 4. patients with prostate volume 20mL or more 5. patients with informed consent
Exclusion criteria
Exclusion criteria: 1. patients who developed urinary retention in the past 12 months 2. patients who had post voiding residual volume 100mL or more 3. patients strongly suspected of prostate cancer 4. patients with indwelling urethral catheter or intermittent self-catheterization 5. patients with acute urinary tract infection 6. patients with nocturnal polyuria 7. patients with daily urine volume over 3000mL 8. patients with mechanical abnormality of lower urinary tract (eg. urethral stricture, bladder tumor and bladder stone) 9. patients without desire to void 10. patients with pyloric, duodenal or intestinal obstruction 11. patients with angle-closure glaucoma 12. patients with myasthenia gravis 13. patients with severe heart disease, renal dysfunction or liver dysfunction 14. patients with severe constipation 15. patients tadalafil and solifenacin is contraindicated 16. patients who have been determined to be unsuitable as a subject by a physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to end point for mean number of micturitions per 24 hours | — |
Countries
Japan
Contacts
Public ContactMitsuhiro Tambo
Kyorin University School of Medicine Department of Urology
Outcome results
None listed