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Alpha-Blockers Prior to Ureteral Access Sheath Placement in Flexible Ureteroscopy: A Randomized Prospective Study

NCT07124299 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-08-15

No results posted yet for this study

Summary

This study aims to evaluate whether the use of alpha-blockers before flexible ureterorenolithotripsy facilitates the passage of the ureteral access sheath. The trial will enroll adult patients diagnosed with kidney stones who are scheduled for flexible ureteroscopy. Participants will be randomly assigned to receive or not receive alpha-blockers for seven days before surgery. The primary outcome is the rate of successful sheath placement without the need for a second procedure. Secondary outcomes include the incidence of ureteral injuries and the need for additional surgical interventions. The goal is to improve surgical efficiency and patient outcomes in the treatment of kidney stones.

Conditions

  • Nephrolithiasis
  • Alpha Blocker
  • Ureteral Access Sheath

Interventions

DRUG

Experimental: Alpha-blocker group

Participants in the experimental arm will receive an oral alpha-blocker (tamsulosin 0.4 mg) once daily for 7 consecutive days before undergoing flexible ureterorenolithotripsy. The medication is intended to relax ureteral smooth muscle fibers, potentially facilitating the insertion of the ureteral access sheath and reducing the need for a secondary procedure. The dose, route, and timing are standardized for all participants in this arm.

DRUG

No intervention (observational study)

Participants in this arm will undergo flexible ureterorenolithotripsy without receiving any alpha-blocker prior to surgery. All other perioperative care and surgical procedures will follow the same protocol as the experimental group.

Sponsors & Collaborators

  • Pedro de Figueiredo Buchalla

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2026-01-01
Completion
2026-02-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07124299 on ClinicalTrials.gov