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.
NCT ID: NCT07202923
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
140 participants
OBSERVATIONAL
2021-07-09
2024-06-02
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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Group I (Tamsulosin)
Non-prestented patients receiving 0.4 mg of Tamsulosin daily for 7 days before RIRS.
No interventions assigned to this group
Group II (Silodosin)
Non-prestented patients receiving 8 mg of Silodosin daily for 7 days before RIRS.
No interventions assigned to this group
Group III
Prestented patients
No interventions assigned to this group
Group IV
Control group (non-prestented patients)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Kidney stone size: ≤2 cm
* Stone density \>1000 Hounsfield units
* Sterile urine culture
Exclusion Criteria
* Urinary tract infections
* Upper urinary tract obstruction
* Prior reconstructive surgeries on the upper urinary tract
18 Years
ALL
No
Sponsors
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St. Luke's Clinical Hospital, Russia
OTHER
Responsible Party
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Mikheev Yury
urologist, St. Luke's Clinical Hospital
Locations
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St. Luke's Clinical Hospital
Saint Petersburg, Outside U.S./Canada, Russia
Countries
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Related Links
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Complete study data is available upon formal request by email . All legitimate data inquiries will be processed in accordance with applicable privacy regulations.
Other Identifiers
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№19/2
Identifier Type: -
Identifier Source: org_study_id
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