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

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 - The study for evaluating the additional effect of tadalafil in patients with the residual storage symptoms even after treatment with alpha-1-adrenoreceptor antagonists

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000017896

Enrollment

100

Registered

2015-07-01

Start date

2015-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign prostatic hyperplasia (BPH)

Interventions

Alpha-1-adrenoreceptor antagonists and tadalafil 5mg combined therapy (12 weeks) Alpha-1-adrenoreceptor antagonists and anti cholinergic agents (Solifenacin succinate or Propiverine hydrochloride) com

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: BPH (prostate volume more than 20 cc) with residual storage symptoms even after treatment with alpha-1-adrenoreceptor antagonists (patients meet the following 1-4 criteria) 1. Total IPSS score: 8 points or more 2. IPSS-QOL score: 2 points or more 3. OABSS: 3 points or more 4. Nighttime voiding frequency: 2 times or more

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
IPSS (International prostate symptom score) storage subscore	—

Secondary

Measure	Time frame
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)	—

Countries

Japan

Contacts

Public ContactShinji Urakami

Toranomon Hospital Urology

shinurakami@ybb.ne.jp03-3588-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026