The effect of tamsulosin in ureteroscopic surgery in dilation of ureter and improve stent-related symptom: A prospective, randomized study
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 200
研究概览
简要总结
Purpose This study aimed to investigate the effect of taking tamsulosin prior to surgery on the successful insertion of a 14 French (F) ureteral access sheath (UAS) during the procedure, as well as the impact of pre- and post-operative tamsulosin use on symptoms related to the ureteral stent. Materials and Methods This study was a randomized, single-center, double-blinded, placebo-controlled trial of 200 patients undergoing retrograde intrarenal surgery. Patients received either tamsulosin (0.4 mg) or placebo from 1 week before the surgery until stent removal. The patients were randomly assigned to one of four groups: Group 1 received tamsulosin throughout the entire study period, Group 2 received tamsulosin before surgery and placebo after surgery, Group 3 received placebo before surgery and tamsulosin after surgery, and group 4 took placebo before and after surgery. The Ureteral Stent Symptoms Questionnaire was completed between postoperative days 7 and 14 just before the stent removal. Results In total, 160 patients were included in the analysis. Their mean age was 55.0 ± 11.0 years, and 48 (30.0%) were female. In the group receiving pre-operative tamsulosin, the success rate of 12/14F UAS deployment was significantly higher compared to the pre-operative placebo group (88.0 vs. 75.3%, p=0.038). Pre- and post-operative tamsulosin use did not significantly alleviate symptoms related to the ureteral stent. Conclusions These results revealed that pre-operative administration of tamsulosin improved the success of larger-sized UAS, while pre- and post-operative tamsulosin use did not significantly alleviate symptoms related to ureteral stents.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •1. Patients between 20 and 80 years old who are planning to undergo ureteroscopy due to unilateral kidney and ureter stones.
- •2. The size of stones is for patients whose total size of all stones in a single kidney or ureter is greater than 5mm and less than 7cm.
- •3. Patients who voluntarily decided to participate in this clinical study and signed a written informed consent.
排除标准
- •1. Patients with a history of hypersensitivity to tamsulosin or its components
- •2. Patients diagnosed with orthostatic hypotension
- •3. Patients with severe liver disorder
- •4. Patients with Galactose intolerance, Lapp lactose deficiency, Glucose-galactose malabsorption
- •5. Patients with severe renal impairment (KDIGO CKD grade 3 or higher)
- •6. Patients with history of renal ureter cancer and bladder cancer
- •7. Patients with a history of ureteral stenosis
- •8. Patients with febrile urinary tract infection (if there is evidence of fever and urinary tract infection above 38 degrees)
- •9. Patients who are single kidneys
- •10. Patients with a history of using tamsulosin, calcium channel blockers and steroids within the last 4 weeks
- •11. Patients with a history of previous intrapelvic surgery or radiation
- •12. Women who may be pregnant or pregnant
- •13. Nursing mothers
- •14. If there is an active disease judged by the researcher to be unsuitable for participation in the study
- •15. Patients with a history of previous unilateral renal and ureteral stones or extracorporeal shock wave lithotripsy
- •16. Patient with ureteral stent inserted before surgery
- •17. Patients taking Warfarin and H2 receptor blocker
- •18. Patients taking CYP3A4 or CYP2D6 inhibitors