Ureterolithiasis
Conditions
Interventions
The subjects will be randomly assigned to tadalafil or placebo groups, and the study will be double blinded. Five mg of tadalafil capsules in the tadalafil administration group or placebo capsules in
Sponsors
Arai Seiji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patients diagnosed with ureteral calculus (2)Patients whose ureteral calculus can be confirmed with KUB (3)Single unilateral ureteral calculus of 3 mm or more and less than 10 mm (size of calculus is evaluated by CT) (4)Patients within 5 days from the onset of ureteral calculi (the day of outpatient visit with colic attack or hematuria) (5)Patients over 20 years old (6)Patients whose written consent for participation in this trial can be obtained
Exclusion criteria
Exclusion criteria: (1)Patients receiving the following drugs 1)PDE5 inhibitor 2)alpha1 blocker 3)Calcium antagonist 4)Steroid agent (except external preparation) 5)Nitric acid agent or nitrogen monoxide (NO) donor (nitroglycerin, amyl nitrite, isosorbide nitrate etc.) 6)Soluble guanylate cyclase (sGC) stimulator (Rio sigato) 7)Drugs that strongly inhibit CYP3A4 (2)Patients with cardiovascular disorders listed below Unstable angina Heart failure (NYHA classification III or higher) Uncontrolled arrhythmia, hypotension (blood pressure 170/100 mmHg) The history of myocardial infarction within 3 months before investigational drug administration The past history of cerebral infarction, cerebral hemorrhage within 6 months before investigational drug administration (3)Patients with moderate renal injury (below) Serum creatinine level: 1.5 x ULN mg / dl or more (4)Patients with severe liver disorder (below) Blood bilirubin level: 3.0 x ULN mg / dl or more Aspartate transferase (AST) value: 5.0 x ULN U / L or more Alanine aminotransferase (ALT) value: 5.0 x ULN U / L or more (5)Patients with concomitant urinary tract infections (fever and positive urinary white blood cells) (6)Patients who need drinking restriction (7)Patients who are pregnant and may be pregnant, or patients who are nursing (8)Patients who can not come to the hospital for evaluation of treatment effect (9)In addition, patients judged to be inappropriate by the investigator or subinvestigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stone removal rate in tadalafil group and placebo group from the onset of ureteral calculus until 28 days of investigational drug administration > Day of outpatient visit for colic attack or hematuria > Confirmation of excreted stone with objective findings such as disappearance of hydronephrosis by US and disappearance of caluculus shadow in KUB. If the excreted stone was not confirmed, it will be judged as stone excretion by the disappearance of pain in the patient diary. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Stone removal period (the number of days from the study drug administration start date to the stone removal) 2)Number of uses of antipyretic analgesic | — |
Contacts
Public ContactSeiji Arai
Gunma University Hospital
Outcome results
None listed