NCT07124299 Alpha-Blockers Prior to Ureteral Access Sheath Placement in Flexible Ureteroscopy: A Randomized Prospective Study
| NCT ID | NCT07124299 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Pedro de Figueiredo Buchalla |
| Condition | Nephrolithiasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 140 participants in total. It began in 2024-01-01 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07124299 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Nephrolithiasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07124299 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07124299 currently recruiting?
Yes, NCT07124299 is actively recruiting participants. Contact the research team at pedrofbuchalla@gmail.com for enrollment information.
Where is the NCT07124299 trial being conducted?
This trial is being conducted at Santo André, Brazil.
Who is sponsoring the NCT07124299 clinical trial?
NCT07124299 is sponsored by Pedro de Figueiredo Buchalla. The trial plans to enroll 140 participants.