Medical Expulsive Therapy for Ureter Stone Using Naftopidil

Medical Expulsive Therapy for Ureter Stone Using Naftopidil: Multicenter, Randomized, Double-blind, Placebo Controlled Study

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.

Inclusion Criteria:

• >= 20 years
• single 3 to 10 mm ureter stone (longest diameter)

Exclusion Criteria:

• Presence of multiple ureter stones
• Renal insufficiency (serum Cr > 1.4 mg/dL)
• Febrile urinary tract infections(fever > 38°C, evidence of urinary infection)
• pregnancy or breast feeding
• solitary kidney
• hypersensitivity to naftopidil
• current use of any alpha-blocker, calcium-channel blocker, corticosteroid (within 4 weeks)
• moderate or severe cardiovascular or cerebrovascular disease
• hepatic dysfunction (>2 x normal upper limit)
• significant active medical illness which in the opinion of the investigator would preclude protocol treatment
• Genetic disorder such as Galactose intolerance, Lapp Lactase deficiency, Glucose-Galactose malabsorption