This study is to investigate whether naftopidil is effective or not for the spontaneous passage of ureteral stones with sizes of 3 to 10 mm.
1. Enrollment 1. patients with ureteral stones of sizes from 3 to 10 mm 2. patients aged more than 18 years 2. Randomization 1. naftopidil 75 mg qd for 14 days or placebo 2. Standard treatment with pain-killers were also applied.(aceclofenac) 3. Follow-up for 28 days 1. We confirm the stone free status by CT or X-ray films at 14th and 28th days. 2. Rates of active treatment will be also evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
naftopidil 75mg 1T qd hs
Placebo 1T qd hs
Aceclofenac 100mg or tramadol37.5mg/acetaminophen 325mg on demand
Donguk University Ilsan Hospital
Goyang, Kyunggi, South Korea
Seoul National University Bundang Hospital
Seongnam, Kyunggi, South Korea
Kangwon National University Hospital
Chuncheon, South Korea
Seoul National University Hospital
Seoul, South Korea
Stone-free rate at 14th day of study
Rate of stone-free as confirmed by non-contrast CT, intravenous urography or simple x-ray (only for radio-opaque stone)
Time frame: 14th day
Stone-free rate at 28th day of study
Time frame: 28th day
Duration to stone passage within 28days of study
Time frame: for 28 days
amount of analgesics used for 28 days of study
Time frame: for 28 days
Rate of active treatment
Active treatments include shock-wave lithotripsy, ureteroscopic ureterolithotomy, ureteral stenting or other surgical treatment
Time frame: for 28 days
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National Medical Center
Seoul, South Korea
Seoul National University Boramae Medical Center
Seoul, South Korea