Tamsulosin and intraureteral aminophylline to improve ureteral access during primary retrograde intrarenal surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized study uses a 2x2 factorial design to compare preoperative tamsulosin, intraureteral aminophylline, both, or neither in adults with unilateral renal stones ≤2 cm planned for primary retrograde intrarenal surgery. Participants are randomized to one of four groups and receive either active drug or placebo capsules for 7 days before surgery, plus intraureteral aminophylline or placebo during the procedure. The primary outcome is successful first-attempt placement of the planned 10/12 Fr ureteral access sheath without the need for additional maneuvers or abandonment of the procedure. The trial aims to determine whether systemic and/or local pharmacologic strategies reduce ureteral resistance or spasm to facilitate access. This is a prospective, double-blind, placebo-controlled study conducted across multiple centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 years or older.
* Unilateral renal stone 2 cm or less in maximal diameter on preoperative imaging.
* Scheduled for primary retrograde intrarenal surgery.
* Ability to provide written informed consent.

Exclusion Criteria:

* Prior ureteral stenting on the study side.
* Bilateral same-session retrograde intrarenal surgery.
* Concomitant ureteral stone requiring primary semirigid ureteroscopy as the main procedure.
* Known ureteral stricture or prior ureteral reconstructive surgery on the study side.
* Active urinary tract infection or untreated positive urine culture.
* Pregnancy.
* Known allergy or contraindication to tamsulosin or aminophylline.
* Significant cardiac arrhythmia, uncontrolled ischemic heart disease, seizure disorder, or hyperthyroidism.
* Severe hepatic impairment.
* Inability to comply with the 7-day preoperative medication protocol.

Where it's running

• Department of Urology- Aswan University Hospitals
  Aswān, Aswan Governorate, Egypt Recruiting
• Department of Urology- Beni-Suef University Hospitals
  Banī Suwayf, Beni Suweif Governorate, Egypt Recruiting
• Urology Department- Sohag university Hospital
  Sohag, Sohag Governorate, Egypt Recruiting

Study contacts

• Principal investigator: Hany F Badawy, MD — Faculty of Medicine, Beni-Suef University
• Study coordinator: Hany F Badawy, MD
• Email: Hanyfathy86@gmail.com@GMAIL.COM
• Phone: +201149525028

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.