Kidney Calculi, Ureter Calculi
Conditions
Keywords
Medical Expulsive therapy
Brief summary
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
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.
Interventions
DRUGnaftopidil 75mg
Sponsors
Dong-A ST Co., Ltd.
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference of the treatment success rate in two weeks after ESWL between treatment group and placebo group | 2 weeks after ESWL | Treatment success is defined as no or less than 3 mm size remnant stone |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference of the treatment success rate after ESWL between treatment group and placebo group | 4, 6 weeks after ESWL | Treatment success is defined as no or less than 3 mm size remnant stone |
| Adverse Event | 2,4,6weeks | Rate of total Adverse Events and Adverse Events relevant to Investigational drug |
| pain scale | baseline, 2, 4, 6 weeks | visual analogue pain scale due to urinary stone |
| rate of additional intervention | 6 week | incidence of additional intervention for the urinary stone ex\> ureteral stent insertion, percutaneous nephrostomy, ureteroscopic ureterolithotomy, percutaneous nephrolithotomy, laparoscopic stone removal and so on |
Other
| Measure | Time frame | Description |
|---|---|---|
| time to stone expulsion | 2,4,6week | the time (days) elapsed from first ESWL to the expulsion of the stone |
| Number of ESWL | 6week | The number of required ESWL for the stone expulsion |
Countries
South Korea
Contacts
Primary ContactDeok Hyun Han, MD
Outcome results
None listed