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

NCT07124299 | Recruiting Phase 4 DMC

• 1 other identifier: FMABC-ALFAURS-2025-01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Nephrolithiasis; Alpha Blocker; Ureteral Access Sheath

Outcome Measures

Primary Outcomes (1)

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

  During the surgical procedure

Study Arms (2)

Experimental: Alpha-blocker group

ACTIVE COMPARATOR

Participants will receive an alpha-blocker (e.g., tamsulosin 0.4 mg orally once daily) for 7 consecutive days prior to flexible ureterorenolithotripsy. The medication aims to relax the ureteral smooth muscle and facilitate the insertion of the ureteral access sheath during surgery. All surgical procedures will follow the standard protocol used in the participating hospitals.

Drug: Experimental: Alpha-blocker group

No Intervention: Control group

PLACEBO COMPARATOR

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.

Drug: No intervention (observational study)

Interventions

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.

Experimental: Alpha-blocker group

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.

No Intervention: Control group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pedro de Figueiredo Buchalla: lead

Study Sites (1)

Centro Universitário FMABC

Santo André, São Paulo, 09060-870, Brazil

RECRUITING

MeSH Terms

Conditions

Nephrolithiasis

Interventions

Observation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Pedro FB Buchalla, MD

CONTACT

+5516997704207; pedrofbuchalla@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Alpha-Blockers Prior to Ureteral Access Sheath Placement in Flexible Ureteroscopy: A Randomized Prospective Study

Study Record Dates

• First Submitted: August 9, 2025
• First Posted: August 15, 2025
• Study Start: January 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-05

Locations

BR (1)