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.

NCT07202923 | Completed

• 1 other identifier: №19/2
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• successful of ureteral access sheath insertion

  Proportion of patients with successful UAS insertion

  Intraoperative

• degree of ureteral injury

  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.

  Perioperative

• postoperative pain

  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).

  6, 24, and 48 hours postoperatively

• Inflammatory markers

  Change in in blood Leukocyte count, 10⁹/L C- reactive protein , mg/l

  Baseline and 24 hours postoperatively

• Factors influencing successful ureteral access sheath insertion

  Multivariate analysis of factors influencing successful UAS insetion. BMI of the patient - kg/m² Age of the patient

  Until the completion of the study, on average 1 year

Secondary Outcomes (2)

• Postoperative complications

  through study completion, an average of 1 year

• Operative time

  Intraoperative (measured from start to end of procedure)

Study Arms (4)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This is an interventional RCT. Population characteristics are described in Eligibility Criteria and Arms sections

You may qualify if:

• Patients aged 18 years and older
• Kidney stone size: ≤2 cm
• Stone density \>1000 Hounsfield units
• Sterile urine culture

You may not qualify if:

• Congenital anomalies of the urinary tract
• Urinary tract infections
• Upper urinary tract obstruction
• Prior reconstructive surgeries on the upper urinary tract

Sponsors & Collaborators

• St. Luke's Clinical Hospital, Russia: lead

Study Sites (1)

St. Luke's Clinical Hospital

Saint Petersburg, Outside U.S./Canada, Russia

Location

Related Links

• Complete study data is available upon formal request by email . All legitimate data inquiries will be processed in accordance with applicable privacy regulations.

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: urologist, St. Luke's Clinical Hospital

Study Record Dates

• First Submitted: August 16, 2025
• First Posted: October 2, 2025
• Study Start: July 9, 2021
• Primary Completion: June 2, 2024
• Study Completion: June 2, 2024
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

RU (1)