drugset / Trial / NCT07623876

Tamsulosin and Intraureteral Aminophylline for Ureteral Access During RIRS

NCT07623876

Phase 2 Recruiting 322 enrolled Beni-Suef University
RandomizedFactorialQuadruple-blindTreatment

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.

Timeline

Start
2026-05-06
Primary completion
2027-04
Completion
2027-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Aminophylline Small molecule 250 mg Other
Subject Tamsulosin Other / unclassified 0.4 mg

Indications