The effect of tamsulosin in ureteroscopic surgery in dilation of ureter and improve stent-related symptom
- Conditions
- Diseases of the genitourinary system
- Registration Number
- KCT0004394
- Lead Sponsor
- Asan Medical Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
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.
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The difference in USSQ scores between groups.
- Secondary Outcome Measures
Name Time Method The size of the ureteral access sheath inserted during surgery.