Tadalafil monotherapy versus tadalafil and solifenacin combined therapy for patients with lower urinary tract symptoms suggestive of benign prostate hyperplasia and overactive bladder: randomized controlled trial
- Conditions
- benign prostate hyperplasia with overactive bladder
- Registration Number
- JPRN-UMIN000016805
- Lead Sponsor
- Department of Urology, Kyorin University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 200
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline to end point for mean number of micturitions per 24 hours
- Secondary Outcome Measures
Name Time Method