Clinical Trial

Tamsulosin and Intraureteral Aminophylline for Ureteral Access During RIRS

Study acronym: TAM-AMIN-UAS
Recruiting Phase 2
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Summary
This multicenter randomized controlled trial will evaluate whether preoperative tamsulosin, intraureteral aminophylline, or their combination can improve ureteral access during primary retrograde intrarenal surgery for renal stones. Adult patients with unilateral renal stones measuring 2 cm or less and planned placement of a 10/12 Fr ureteral access sheath will be randomly assigned to one of four groups in a 2x2 factorial design. Participants will receive either tamsulosin or placebo for 7 days before surgery and either intraureteral aminophylline or intraureteral placebo during the procedure. The main outcome will be successful first-attempt placement of the planned 10/12 Fr ureteral access sheath after study solution instillation, without active ureteral dilatation, sheath downsizing, prestenting with deferred surgery, or abandonment of the procedure due to access failure.
Trial Details
NCT Number NCT07623876
Lead Sponsor Beni-Suef University
Conditions Renal Stones, Retrograde Intrarenal Surgery, Ureteral Access Sheath Placement
Enrollment 322 participants
Start Date 2026-05-06
Primary Completion 2027-04 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2026-06-03