Alpha-blockers before flexible ureteroscopy to ease ureteral access sheath placement.
Official title: Prospective, Randomized Study on the Efficiency of Alpha-Blockers Prior to Ureteral Sheath Placement in Flexible Ureterolithotripsy
Run by Centro Universitário FMABC · NCT07124299 · Data updated 2026-11-12
This trial will test whether taking an alpha-blocker for seven days before flexible ureteroscopy helps surgeons place the ureteral access sheath in adults with kidney stones.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 140 (estimated) |
| Sponsor | Centro Universitário FMABC Academic / other |
| Locations | 1 site (Santo André, São Paulo) |
| Status | Recruiting |
| Started | January 1, 2024 |
| Main results expected | January 1, 2026 |
| Study ends | February 1, 2026 |
| Registry record updated | August 15, 2025 |
| Trial ID | NCT07124299 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with kidney stones who are scheduled for flexible ureterorenolithotripsy, can provide informed consent, and are not already on chronic alpha-blocker therapy or recently stented/operated on the same side are the intended participants.
✕Probably not a fit
Patients with ureteral strictures, prior ureteral reconstructive surgery, recent ipsilateral ureteroscopy or double-J stent placement, chronic alpha-blocker use, or pregnancy are excluded and would not benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized prospective phase 4 trial enrolling adults with nephrolithiasis who are scheduled for flexible ureterorenolithotripsy at Centro Universitário FMABC. Participants are randomly assigned to receive an alpha-blocker for seven days before surgery or to proceed without preoperative alpha-blocker therapy. The primary outcome is successful ureteral access sheath placement without the need for a second procedure, and secondary outcomes include ureteral injury rates and the need for additional surgical interventions. The trial tests whether short-term pharmacologic relaxation of the ureter improves intraoperative efficiency and patient outcomes.
Why it matters
Potential benefit: If successful, preoperative alpha-blocker use could increase first-attempt sheath placement, reduce additional procedures and ureteral injuries, and shorten overall treatment for kidney stones.
How similar studies have gone: Some prior studies and clinical experience suggest alpha-blockers can relax the ureter and aid stone passage or instrument passage, but randomized data specifically for improving ureteral access sheath placement are limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Centro Universitário FMABC
Santo André, São Paulo, Brazil Recruiting
Study contacts
- Study coordinator: Pedro FB Buchalla, MD
- Email: pedrofbuchalla@gmail.com
- Phone: +5516997704207
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Suction vs Conventional Ureteral Access Sheaths in Kidney Stone Surgery
This study tests whether using a suction ureteral access sheath during RIRS helps adults clear stones more often and potentially reduces operative time and infections compared with a conventional sheath.
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Long-term safety of UAS-assisted vs sheathless RIRS in adults with kidney stones
This study tests whether using a ureteral access sheath during the initial RIRS affects long-term safety and outcomes in adults with kidney stones ≤20 mm.
-
Observation vs Upfront Surgery for Asymptomatic Kidney Stones in Children and Adults
This trial tests whether watching asymptomatic kidney stones or performing upfront surgery is better for reducing life disruption in patients aged 6 and older.
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Tract Closure with Hemostatic Agent in PCNL
This trial tests whether applying a hemostatic agent during tract closure in PCNL helps reduce blood loss compared with balloon tamponade alone.
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Suction to collapse the kidney's collecting system after RIRS (retrograde intrarenal surgery)
This trial will test whether actively suctioning the kidney's collecting system at the end of RIRS reduces early postoperative pain and infections for adults having kidney stone removal.
-
Early versus delayed shock wave treatment for leftover kidney stones after percutaneous nephrolithotomy
This trial tests whether doing extracorporeal shock wave lithotripsy (ESWL) early or waiting longer after PCNL helps clear leftover kidney stone fragments ≤15 mm with fewer complications.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.