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

ConditionsNephrolithiasis Alpha Blocker Ureteral Access Sheath

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorPedro de Figueiredo Buchalla

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Diagnosis of nephrolithiasis with surgical indication for flexible ureterorenolithotripsy

Ability to provide written informed consent

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

140 Participants

are divided into 2 treatment groups

Group A: Experimental: Alpha-blocker groupActive comparator 1 intervention

Group B: No Intervention: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

During the surgical procedure

Sponsors and contacts

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Pedro de Figueiredo Buchalla

Lead sponsor

Centro Universitário FMABC

Sponsor institution

Source ClinicalTrials.gov

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