RecruitingPhase 4NCT07124299

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

Prospective, Randomized Study on the Efficiency of Alpha-Blockers Prior to Ureteral Sheath Placement in Flexible Ureterolithotripsy

Sponsor

Pedro de Figueiredo Buchalla

Enrollment

140 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Nephrolithiasis Alpha Blocker Ureteral Access Sheath

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria5

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

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Interventions

DRUGExperimental: 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.

DRUGNo 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.