Alpha-blockers before flexible ureteroscopy to ease ureteral access sheath placement.
Prospective, Randomized Study on the Efficiency of Alpha-Blockers Prior to Ureteral Sheath Placement in Flexible Ureterolithotripsy
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 |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centro Universitário FMABC Academic / other |
| Locations | 1 site (Santo André, São Paulo) |
| Trial ID | NCT07124299 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Santo André, São Paulo
- Centro Universitário FMABC — Santo André, São Paulo, Brazil (Recruiting)
Study contacts
- Study coordinator: Pedro FB Buchalla, MD
- Email: pedrofbuchalla@gmail.com
- Phone: +5516997704207
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.