Actively Recruiting
Prospective, Randomized Study on Alpha-Blockers Before Ureteral Sheath Placement in Flexible Ureterorenolithotripsy
Led by Pedro de Figueiredo Buchalla · Updated on 2025-08-15
140
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether taking alpha-blockers before flexible ureterorenolithotripsy helps in the easier placement of a ureteral access sheath during kidney stone surgery. This phase 4 randomized trial involves adults diagnosed with nephrolithiasis who need flexible ureteroscopy. The goal is to see if alpha-blockers improve surgical success and reduce the need for additional procedures while monitoring safety outcomes like ureteral injuries. Participants will be randomly assigned to one of two groups. One group will take an oral alpha-blocker (such as tamsulosin 0.4 mg) once daily for seven days before surgery to relax the ureteral muscles and assist sheath insertion. The other group will undergo the same surgery without preoperative alpha-blockers. Both groups will follow the same surgical protocols. During the study, participants will have their surgery and be assessed for successful ureteral sheath placement during the procedure. Researchers will also track any ureteral injuries and the need for further surgical interventions. The primary measure is the rate of successful sheath insertion without needing a second procedure. The study will include visits and monitoring before, during, and after the surgery, with total participation lasting through the surgical and immediate perioperative period.
CONDITIONS
Brief Title
Alpha-Blockers Prior to Ureteral Access Sheath Placement in Flexible Ureteroscopy: A Randomized Prospective Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of nephrolithiasis requiring flexible ureterorenolithotripsy surgery
- Ability to provide written informed consent
You will not qualify if you...
- Age less than 18 years
- Pregnancy
- History of ureteral stricture, prior ureteral reconstructive surgery, or abdominal/pelvic radiotherapy
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 7 days
Participants receive an oral alpha-blocker once daily for 7 consecutive days before undergoing flexible ureterorenolithotripsy surgery or undergo surgery without alpha-blocker pre-treatment depending on group assignment.
1 baseline visit before treatment and surgery
Duration - Up to 1 day post-surgery
Participants are monitored after surgery to assess surgical outcomes and recovery.
1 post-operative visit
Trial Site Locations
Total: 1 location
1
Centro Universitário FMABC
Santo André, São Paulo, Brazil, 09060-870
Actively Recruiting
Research Team
P
Pedro FB Buchalla, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NA
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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