Study of Tamsulosin and Intraureteral Aminophylline to Help Place Ureteral Access Sheath During Kidney Stone Surgery

What this Trial Is About

Researchers are evaluating whether preoperative tamsulosin, intraureteral aminophylline, or their combination can improve ureteral access during primary retrograde intrarenal surgery for adults with unilateral renal stones measuring 2 cm or less. This multicenter randomized controlled trial aims to reduce difficulties in placing a ureteral access sheath, which can cause trauma or require additional procedures. The trial uses a 2x2 factorial design to compare the effects of systemic and local drugs on ureteral relaxation during surgery. Participants are randomly assigned to one of four groups receiving either tamsulosin or placebo capsules daily for 7 days before surgery and either intraureteral aminophylline or placebo during the procedure. The intraureteral solution is instilled through a catheter in the distal ureter, followed by a 5-minute wait before attempting to place the planned 1012 Fr ureteral access sheath. Rescue treatments such as active dilatation or stenting with deferred surgery are used if sheath placement fails safely. During the study, participants will undergo assessments of ureteral access success, need for rescue maneuvers, ureteral injury, operative outcomes, postoperative pain, complications, hospital stay, and stone clearance. The main outcome is successful sheath placement on the first attempt without additional interventions. The study is double-blind and will monitor participants closely during and after surgery, with follow-up visits to evaluate results and safety over time.

Tamsulosin and Intraureteral Aminophylline for Ureteral Access During RIRS