Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 and up

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

PhasePhase 4
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment140 (estimated)
SponsorCentro Universitário FMABC
Academic / other
Locations1 site (Santo André, São Paulo)
StatusRecruiting
StartedJanuary 1, 2024
Main results expectedJanuary 1, 2026
Study endsFebruary 1, 2026
Registry record updatedAugust 15, 2025
Trial IDNCT07124299 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.