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

Not Applicable

Recruiting

• Conditions: Nephrolithiasis; Alpha Blocker; Ureteral Access Sheath
• Interventions: Drug: No intervention (observational study)

• Registration Number: NCT07124299
• Lead Sponsor: Pedro de Figueiredo Buchalla

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2025-05
• Study First Submitted: 2025-08-09
• Study First Submitted QC: 2025-08-09
• Last Update Submitted: 2025-08-09
• Study First Posted: 2025-08-15
• Last Update Posted: 2025-08-15
• Primary Completion: 2026-01-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Intervention: Control group	No intervention (observational study)	Participants will undergo flexible ureterorenolithotripsy without the use of alpha-blockers prior to surgery. All other aspects of perioperative care and surgical technique will be identical to those of the experimental group.

Primary Outcome Measures

Name	Time	Method
Reduction in the failure rate of ureteral access sheath insertion with preoperative tamsulosin use	During the surgical procedure

Trial Locations

Locations (1)

Centro Universitário FMABC; 🇧🇷 Santo Andre, Sao Paulo, Brazil