Tamsulosin and Intraureteral Aminophylline for Ureteral Access During RIRS

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeni-Suef University

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Tamsulosin
  • Placebo Capsule
  • Intraureteral Aminophylline
  • Intraureteral Placebo

Treatment groups

322 Participants
are divided into 4 treatment groups

Sponsors and collaborators