Alpha Blocker, Nephrolithiasis, Ureteral Access Sheath
Conditions
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.
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.
Sponsors
Pedro de Figueiredo Buchalla
Study design
Allocation
NA
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in the failure rate of ureteral access sheath insertion with preoperative tamsulosin use | During the surgical procedure |
Countries
Brazil
Contacts
Primary ContactPedro FB Buchalla, MD
Outcome results
None listed