Naftopidil 75mg for Improving Clearance of Urinary Stones

Study Overview
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Brief Summary
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The purpose of this study is to evaluate Efficacy and Safety of oral intake of Naftopidil 75mg once daily for the improving clearance of ureteral or renal stones.

Detailed Description
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Prospective, Single-center, Double blind, Randomized controlled trial Treatment - Oral Naftopidil 75 mg once daily are given to the patients who are scheduled for shockwave lithotripsy (ESWL) because of ureteral or renal stones. Follow up Assessments including X-ray(KUB), visual analogue pain scale, are done 2, 4, and 6 weeks after the ESWL.

Official Title
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The Effectiveness and Safety of Naftopidil 75mg for Improving Clearance of Ureteral and Renal Stones After Shockwave Lithotripsy: Prospective Randomized Controlled Study

Conditions
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Kidney Calculi, Ureter Calculi

Intervention / Treatment
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* Drug: naftopidil 75mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Radio-opaque (identifiable in KUB) ureter or kidney calculi size criteria is from 5mm to 15mm Exclusion Criteria: Symptomatic acute urinary tract infection during the run-in period severe hydronephrosis 2 or more urinary stones Radiolucent (non-visible in KUB) stone recent intervention for the urinary stone within 6 month Patients who have ureteral stent over 2.0 mg/dl of serum creatinine level severe hepatic dysfunction orthostatic hypotension current usage of alpha-adrenergic blocker or calcium channel blocker Pregnant or nursing women Age under 15 year severe or uncontrolled medical conditions

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Naftopidil<br>Naftopidil 75mg once daily | Drug: naftopidil 75mg<br> <br> |
| Placebo Comparator: Placebo<br>Placebo once daily | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of the treatment success rate in two weeks after ESWL between treatment group and placebo group | Treatment success is defined as no or less than 3 mm size remnant stone | 2 weeks after ESWL | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of the treatment success rate after ESWL between treatment group and placebo group | Treatment success is defined as no or less than 3 mm size remnant stone | 4, 6 weeks after ESWL | 
| Adverse Event | Rate of total Adverse Events and Adverse Events relevant to Investigational drug | 2,4,6weeks | 
| pain scale | visual analogue pain scale due to urinary stone | baseline, 2, 4, 6 weeks | 
| rate of additional intervention | incidence of additional intervention for the urinary stone ex> ureteral stent insertion, percutaneous nephrostomy, ureteroscopic ureterolithotomy, percutaneous nephrolithotomy, laparoscopic stone removal and so on | 6 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medical Expulsive therapy