Alpha-Blockers Prior to Ureteral Access Sheath Placement in Flexible Ureteroscopy: A Randomized Prospective Study
NCT ID: NCT07124299
Last Updated: 2025-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
140 participants
INTERVENTIONAL
2024-01-01
2026-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental: Alpha-blocker group
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.
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.
No Intervention: Control group
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of nephrolithiasis with surgical indication for flexible ureterorenolithotripsy
* Ability to provide written informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Pedro de Figueiredo Buchalla
OTHER
Responsible Party
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Pedro de Figueiredo Buchalla
Alpha-Blockers Prior to Ureteral Access Sheath Placement in Flexible Ureteroscopy: A Randomized Prospective Study
Locations
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Centro Universitário FMABC
Santo André, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FMABC-ALFAURS-2025-01
Identifier Type: -
Identifier Source: org_study_id
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