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Tamsulosin and Intraureteral Aminophylline for Ureteral Access During RIRS
Sponsor: Beni-Suef University
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.
Official title: Comparative Efficacy of Tamsulosin, Intraureteral Aminophylline, and Their Combination in Facilitating Ureteral Access During Retrograde Intrarenal Surgery: A Multicenter Randomized Controlled Trial.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
322
Start Date
2026-05-06
Completion Date
2027-05
Last Updated
2026-06-03
Healthy Volunteers
No
Interventions
Tamsulosin
Tamsulosin 0.4 mg capsule once daily for 7 days before retrograde intrarenal surgery.
Placebo Capsule
Matching placebo capsule for tamsulosin, taken once daily for 7 days before retrograde intrarenal surgery.
Intraureteral Aminophylline
Aminophylline 250 mg/10 mL will be diluted with 10 mL normal saline 0.9% to a total volume of 20 mL. The solution will be instilled intraureterally through an open-end ureteric catheter positioned in the distal ureter on the study side. After a standardized 5-minute waiting period, one controlled attempt will be made to place the planned 10/12 Fr ureteral access sheath.
Intraureteral Placebo
Normal saline 0.9% to a total volume of 20 mL will be instilled intraureterally through an open-end ureteric catheter positioned in the distal ureter on the study side. After a standardized 5-minute waiting period, one controlled attempt will be made to place the planned 10/12 Fr ureteral access sheath.
Locations (3)
Department of Urology- Aswan University Hospitals
Aswān, Aswan Governorate, Egypt
Department of Urology- Beni-Suef University Hospitals
Banī Suwayf, Beni Suweif Governorate, Egypt
Urology Department- Sohag university Hospital
Sohag, Sohag Governorate, Egypt