Alpha-Blockers Prior to Ureteral Access Sheath Placement in Flexible Ureteroscopy: A Randomized Prospective Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental: Alpha-blocker group, No intervention (observational study).
- Who it may be relevant to
- Registry conditions: Nephrolithiasis, Alpha Blocker, Ureteral Access Sheath. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective, Randomized Study on the Efficiency of Alpha-Blockers Prior to Ureteral Sheath Placement in Flexible Ureterolithotripsy
Overview
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.
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.
Primary outcome measures
- Reduction in the failure rate of ureteral access sheath insertion with preoperative tamsulosin use [Time frame: During the surgical procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Centro Universitário FMABC — Santo André
Identifiers
NCT: NCT07124299 · FMABC-ALFAURS-2025-01