A Phase 4 interventional study of Experimental: Alpha-blocker group and No intervention (observational study) in Nephrolithiasis, Alpha Blocker and Ureteral Access Sheath, sponsored by Pedro de Figueiredo Buchalla. Recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-15.
Sponsored by Pedro de Figueiredo Buchalla · Phase 4, Interventional, and Treatment
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.
460 studies on the registry are indexed under Nephrolithiasis; 108 are open to participants now.
This study's planned enrollment of 140 is above the median of 92 across 361 interventional studies indexed under Nephrolithiasis.
Browse Nephrolithiasis studies →This is the only study on the registry with Pedro de Figueiredo Buchalla as lead sponsor.
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Exclusion Criteria:
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.
Drug: Experimental: Alpha-blocker 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.
Drug: No intervention (observational study)
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.
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.
Reduction in the failure rate of ureteral access sheath insertion with preoperative tamsulosin use
Time frame: During the surgical procedure
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