The study for evaluating the additional effect of tadalafil in patients with the residual lower urinary tract storage symptoms even after treatment with alpha-1-adrenoreceptor antagonists
- Conditions
- Benign prostatic hyperplasia (BPH)
- Registration Number
- JPRN-UMIN000017896
- Lead Sponsor
- Toranomon Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- 100
Not provided
1. Patients under 50 years old 2. Patients with a history of known serious hypersensitivity reaction to tadalafil, solifenacin succinate or propiverine hydrochloride 3. Patients using nitrates or nitric oxide donors in any form (e.g. nitroglycerin, amyl nitrite or isosorbide dinitrate) 4. Patients using sGC (soluble guanylate cyclase) stimulator (riociguat) 5. Patients with unstable angina 6. Patients with heart failure (NYHA (New York Heart Association) Class 3 or greater) 7. Patients with inadequately controlled arrhythmia, hypotension (blood pressure lower than 90/50 mmHg) or inadequately controlled hypertension (blood pressure at rest higher than 170/100 mmHg) 8. Patients with a history of myocardial infarction within the last 3 months 9. Patients with a history of brain infarction/cerebral hemorrhage within the last 6 months 10. Patients with severe renal impairment 11. Patients with severe hepatic impairment (Child-Pugh Class C) 12. Patients with ischuria 13. Patients with closed angle glaucoma 14. Patients with obstruction in pyrolic part of stomach, duodenal ileus, enterocleisis, or paralytic ileus 15. Patients with gastroatonia/ intestinal atonia 16. Patients with myasthenia gravis 17. Patients with severe cardiac disease 18. Patients with prostate volume more than 50 cc 19. Patients with malignant tumor 20. Patients with a history of intrapelvic surgery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method IPSS (International prostate symptom score) storage subscore
- Secondary Outcome Measures
Name Time Method IPSS-QOL score, OABSS, N-QOL (Nocturia Quality of Life questionnaire) score, adverse events, residual urine volume, Qmax, Qave, PGI-I (Patient Global Impression of Improvement), CGI-I (Clinician Global Impression of Improvement)