Medical expulsive therapy for ureter stone using Naftopidil
- Conditions
- Diseases of the genitourinary system
- Registration Number
- KCT0001289
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
To evaluate the effect of naftopidil 75mg once daily for ureteral double-J (DJ) stent-related discomfort after a ureteroscopic procedure using a multicenter, randomized, double-blinded, placebo-controlled study. 100 patients with indwelled retrograde DJ ureteral stents after ureteroscopic stone removal or retrograde intrarenal surgery (RIRS) were randomized 1:1 to receive either placebo or naftopidil during the stenting period. At the time of stent removal, the Ureteral Stent Symptom Questionnaire (USSQ), the International Prostate Symptom Score and the total amount of used analgesics were reported. Of the 92 patients who completed the study, 49 patients were enrolled in the placebo group, and 43 patients in the naftopidil group. USSQ urinary symptom scores (30.90 vs. 29.23, p=0.299) and USSQ body pain scores (22.28 vs. 19.58, respectively, p=0.286) were lower in the naftopidil group than in the placebo group, but the difference was not significant. Multivariate analysis showed that the use of a ureteral access sheath during RIRS was the only significant predictor of postoperative DJ-related pain (OR=2.736, p=0.031). The use of naftopidil once daily did not significantly reduce DJ ureteral stentrelated discomfort. Larger-scaled prospective studies should be conducted to evaluate the effects of naftopidil on DJ stent-related symptoms and surgeries.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 150
1. = 20 years
2. Patients with a single 3 to 10 mm ureter stone (longest diameter)
1. Presence of multiple ureter stones
2. Renal insufficiency (serum Cr > 1.4)
3. Febrile urinary tract infection (fever > 38°, evidence of urinary infection)
4. Pregnancy or breast feeding
5. Solitary kidney
6. Hypersensitivity to Naftopidil
7. Current use of any alpha-blocker, calcium-channel blocker, corticosteroid
(within 4 weeks)
8. Moderate or severe cardiovascular or cerebrovascular disease
9. Hepatic dysfunction (>2 x normal liver function test)
10. Significant active medical illness which in the opinion of the investigator wo
uld preclude protocol treatment
11. Genetic disorder such as Galatose intolerance, Lapp Lactase deficiency, G
lucose-Galactose malabsorption
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Stone passage rate at 14th day of medication
- Secondary Outcome Measures
Name Time Method stone passage rate at 28th day of medication ;Day of stone passage within 4 weeks of medication;amount of analgesics used for 28 days of medication ;Rate of active treatment