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临床试验/KCT0001289
KCT0001289已完成未知

Medical expulsive therapy for ureter stone using Naftopidil: Multicenter, randomized, double-blind, placebo controlled study

Seoul National University Hospital0 个研究点目标入组 150 人开始时间: 待定最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
150

研究概览

简要总结

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.

研究设计

研究类型
Interventional Study

入排标准

年龄范围
20(Year) 至 o Limit(—)
性别
All

入选标准

  • 1. = 20 years
  • 2. Patients with a single 3 to 10 mm ureter stone (longest diameter)

排除标准

  • 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

研究者

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