NCT07202923

Effect of Preoperative Alpha-blockers on Successful Insertion Ureteral Access Sheath and Reduce Ureteral Injury in Non-prestented Patients During RIRS. Assessment of Factors for Successful Ureteral Access Sheath Insertion.

Effect of Preoperative Tamsulosin and Silodosin on Successful Insertion Ureteral Access Sheath and Reduce Ureteral Injury in Non-Prestented Patients During Retrograde Intrarenal Surgery (RIRS). Assessment of Factors for Successful Ureteral Access Sheath Insertion. Randomized Clinical Trial.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 140 (actual)
• Sponsor: St. Luke's Clinical Hospital, Russia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to evaluate the effect of preoperative taking alpha-blockers (tamsulosin or silodosin) on the success rate of ureteral access sheath (UAS) insertion and the degree of ureteral injury during RIRS in non-prestented patients. The results showed that patients who received alpha-blockers had a higher rate of successful UAS insertion and a lower degree of ureteral injury compared to non-prestented patients. In addition, patients with a BMI greater than 25 kg/m² and those older than 59 years demonstrated a higher success rate of UAS insertion and lower degree of ureteral injury.

Detailed description

Study Title: Effect of Preoperative Tamsulosin and Silodosin on Successful Insertion Ureteral Access Sheath and Reduce Ureteral Injury in Non-Prestented Patients During Retrograde Intrarenal Surgery (RIRS). Assessment of factors for successful ureteral access sheath insertion. Randomized clinical trial. Study Design: Prospective, randomized, open-label, controlled trial with four parallel arms. Conducted from July 2021 to June 2024. Study Center: Department of Urology, St. Luke's Clinical Hospital, St. Petersburg, Russia Study Population: 140 patients, divided into four equal groups of 35 people each: Group I (Tamsulosin): Non-prestented patients receiving 0.4 mg of Tamsulosin daily for 7 days before RIRS. Group II (Silodosin): Non-prestented patients receiving 8 mg of Silodosin daily for 7 days before RIRS. Group III: Prestented patients. Group IV: Control group (non-prestented patients) Interventions: All patients received antibiotic prophylaxis with third-generation cephalosporins 30 minutes before surgery. RIRS was performed using disposable flexible ureteroscopes. The UAS diameter was 11/13 Fr. Thulium fiber laser was used for lithotripsy. Stone fragmentation was performed in dusting and fragmentation modes, with a total power not exceeding 20 W and a fiber thickness of 200 µm. Statistical Analysis: Data were analyzed using Shapiro-Wilk, Mann-Whitney U, Kruskal-Wallis, and chi-square tests with Bonferroni correction (SPSS v26, JMP Pro 17). Statistical significance was set at p\<0.05. Key Findings: Comparable baseline characteristics (p\>0.05) Significantly higher UAS success rates: Tamsulosin: 31 (88.57%) Silodosin: 32 (91.43%) Prestented: 33 (94.29%) Control: 62.86% (p=0.0008) Preoperative taking Silodosin significantly reduced degree ureteral injury (p=0.0253). Patients receiving alpha-blockers experienced less postoperative pain compared to the control group (p\<0.0001) and less inflammatory changes in blood tests compared to prestented patients (WBC: p=0.0002; CRP: p\<0.0001) Patients with BMI ≥ 25 kg/m² and age ≥ 59 years had a higher success rate of UAS insertion (p\<0,0001). Patients with BMI ≥ 25 kg/m² and age ≥ 59 years have a lower degree of ureteral injury (p\<0,0001). Conclusions: Preoperative taking of alpha-blockers (Tamsulosin or Silodosin) increases the success of UAS insertion. Silodosin reduces the degree ureteral injury. Patients taking alpha-blockers less postoperative pain and inflammatory changes in blood tests. A BMI ≥ 25 kg/m² and age ≥ 59 years increase the success of UAS insertion and reduce degree of ureteral injury Clinical Implications: This study provides evidence supporting the use of alpha-blockers, particularly silodosin, for passive ureteral dilation prior to RIRS in non-prestented patients, potentially reducing compications and improving patient outcomes.

Conditions

• Urolithiasis
• Ureteral Injury
• Ureteral Access Sheath
• Retrograde Intrarenal Surgery

Timeline

• Start date: 2021-07-09
• Primary completion: 2024-06-02
• Completion: 2024-06-02
• First posted: 2025-10-02
• Last updated: 2025-11-24

Locations

1 site across 1 country: Russia