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USE OF ALPHA-BLOCKERS BEFORE RIRS. ASSESSMENT OF FACTORS FOR SUCCESSFUL URETERAL ACCESS SHEATH INSERTION. A RANDOMIZED CLINICAL STUDY

Completed
Conditions
Nephrolithiasis(Primary)
Ureteral Injury (Secondary, as This Assesses Prevention)
Pharmacologic Facilitation of Ureteral Access
Registration Number
NCT07202923
Lead Sponsor
St. Luke's Clinical Hospital, Russia
Brief Summary

This study tested whether taking alpha-blocker pills (tamsulosin or silodosin) before kidney stone surgery helps doctors place a ureteral access tube more easily. We compared 140 patients divided into four groups:

Two groups took tamsulosin or silodosin for 7 days before surgery, One group had a pre-placed stent, One group received no preparation (control). Results showed that patients taking alpha-blockers (especially silodosin) had higher success rates for tube placement (89-94% vs. 63% in controls) and less pain after surgery. They also had lower signs of inflammation in blood tests. Older patients (age 59+) and those with higher BMI (≥25) benefited the most.

These drugs may make kidney stone surgery safer and more effective for patients without pre-placed stents.

Detailed Description

Study Title:

Randomized Comparative Study on the Efficacy of Tamsulosin versus Silodosin in Facilitating Ureteral Access Sheath Placement in Non-Prestented Patients Undergoing Retrograde Intrarenal Surgery (RIRS)

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 with renal stones (≤2 cm) were randomized into four equal groups (n=35 each):

Tamsulosin group (0.4 mg daily for 7 days preoperatively)

Silodosin group (8 mg daily for 7 days preoperatively)

Prestented control group

Non-prestented control group (no pharmacologic preparation)

Inclusion Criteria:

Age ≥18 years

Renal calculi ≤2 cm in diameter

Stone density \>1000 Hounsfield units

Sterile urine culture

Exclusion Criteria:

Congenital urinary tract anomalies

Active urinary tract infection

History of upper urinary tract reconstruction

Upper urinary tract obstruction

Interventions:

All patients received third-generation cephalosporin prophylaxis. RIRS was performed using flexible ureteroscopes with 11/13Fr ureteral access sheaths. Lithotripsy was conducted using thulium fiber laser (maximum power 20W, 200μm fiber) in dusting and fragmentation modes.

Outcome Measures:

Primary endpoints:

Ureteral access sheath placement success rate

Degree of ureteral injury (PULS scale)

Secondary endpoints:

Operative time

Postoperative pain (VAS score)

Inflammatory markers (WBC count, CRP levels)

Complications (Clavien-Dindo classification)

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: 88.57%

Silodosin: 91.43%

Prestented: 94.29%

Control: 62.86% (p=0.0008)

Silodosin significantly reduced ureteral injury risk (p=0.0253)

Lower postoperative pain scores in alpha-blocker groups (p\<0.0001)

Reduced inflammatory response in treatment groups (WBC: p=0.0002; CRP: p\<0.0001)

Conclusions:

Alpha-blockers improve ureteral access sheath placement success in non-prestented patients

Silodosin demonstrates superior ureteral protection

Patients with BMI ≥25 kg/m² and age ≥59 years show better outcomes

Alpha-blocker pretreatment reduces postoperative pain and inflammation

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 operative challenges and improving patient outcomes.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
140
Inclusion Criteria

Patients over 18 years with renal stones up to 2 cm in size, density above 1000 HU, and no pathogenic flora in urine culture

Exclusion Criteria
  • congenital anomalies of the urinary tract, urinary tract infections, upper urinary tract obstruction, or prior reconstructive surgeries on the upper urinary tract

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
success of ureteral access sheath placementIntraoperative

Proportion of patients with successful first-attempt UAS placement

degree of ureteral injuryPerioperative

Assessed using the PULS scale.Post-Ureteral Lesion Scale. Grade 0: No injury - intact ureter with no visible damage. Grade 1: Superficial mucosal injury - minor abrasions or erosions without disruption of the ureteral wall.

Grade 2: Partial thickness injury - damage involving part of the ureteral wall, without full-thickness perforation; may have localized bleeding.

Grade 3: Full-thickness ureteral injury - perforation of the ureteral wall with urine leakage, but the injury is limited in size.

Grade 4: Extensive ureteral damage - large perforation with significant tissue destruction.

Grade 5: Complete transection or avulsion - full disruption with loss of ureteral tissue, typically requiring complex reconstructive surgery.

postoperative pain6, 24, and 48 hours postoperatively

Patient-reported pain intensity. The Visual Analog Scale for Pain (VASP) is a widely used, validated tool for the subjective measurement of pain intensity. It consists of a straight line, typically 10 centimeters (100 millimeters) in length, anchored by two verbal descriptors: "no pain" at the zero end and "worst imaginable pain" at the opposite end.

Participants rate their current pain level by marking a point along the line that corresponds to their perception of pain intensity. The distance from the zero point to the mark (measured in millimeters or centimeters) quantifies the pain intensity on a continuous scale from 0 to 10 (or 0 to 100).

Operative timeIntraoperative (measured from start to end of procedure)

total operation time

Inflammatory markersBaseline and 24 hours postoperatively

Change in white blood cell count

Leukocyte count, 10⁹/L

Secondary Outcome Measures
NameTimeMethod
Inflammatory markersBaseline and 24 hours postoperatively

C-reactive protein, mg/L

Postoperative complicationsthrough study completion, an average of 1 year

Complications graded by Clavien-Dindo classification

Predictive factors for UAS successthrough study completion, an average of 1 year

Multivariate analysis of factors influencing successful sheath placemen

Trial Locations

Locations (1)

St. Luke's Clinical Hospital

🇷🇺

Saint Petersburg, Russia

St. Luke's Clinical Hospital
🇷🇺Saint Petersburg, Russia

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