RecruitingPhase 2NCT07623876

Tamsulosin and Intraureteral Aminophylline for Ureteral Access During RIRS

Comparative Efficacy of Tamsulosin, Intraureteral Aminophylline, and Their Combination in Facilitating Ureteral Access During Retrograde Intrarenal Surgery: A Multicenter Randomized Controlled Trial.


Sponsor

Beni-Suef University

Enrollment

322 participants

Start Date

May 6, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Intraureteral Aminophylline, a drug called Intraureteral Placebo, and others for people with renal stones, retrograde intrarenal surgery, and other related conditions. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGTamsulosin

Tamsulosin 0.4 mg capsule once daily for 7 days before retrograde intrarenal surgery.

DRUGPlacebo Capsule

Matching placebo capsule for tamsulosin, taken once daily for 7 days before retrograde intrarenal surgery.

DRUGIntraureteral 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.

DRUGIntraureteral 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07623876


Related Trials