Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07124299

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Nephrolithiasis Alpha Blocker Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Ureteral Access Sheath Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centro Universitário FMABC

Santo André, São Paulo, 09060-870, Brazil

Location status: Recruiting

Location contact

Pedro Buchalla

CONTACT

[email protected]

+5516997704207

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Diagnosis of nephrolithiasis with surgical indication for flexible ureterorenolithotripsy
  • Ability to provide written informed consent

Exclusion criteria

  • Age < 18 years
  • Pregnancy
  • History of ureteral stricture, prior ureteral reconstructive surgery, and/or abdominal or pelvic radiotherapy
  • Prior ureteroscopy or ipsilateral double-J stent placement within the past 3 months
  • Chronic use of alpha-blockers for benign prostatic hyperplasia or medical expulsive therapy for ureteral stones

Treatment and study plan

Experimental: Alpha-blocker group

Drug

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.

No intervention (observational study)

Drug

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.

Primary outcomes

  1. Reduction in the failure rate of ureteral access sheath insertion with preoperative tamsulosin use

    Time frame: During the surgical procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Pedro FB Buchalla, MD

CONTACT

[email protected]

+5516997704207

Sponsors and collaborators

Lead sponsor

Pedro de Figueiredo Buchalla

Other

Registry information

Official study title

Prospective, Randomized Study on the Efficiency of Alpha-Blockers Prior to Ureteral Sheath Placement in Flexible Ureterolithotripsy

Acronym: ALFA-URS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 15, 2025
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.