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Tamsulosin and Intraureteral Aminophylline for Ureteral Access During RIRS

NCT07623876 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 322

Last updated 2026-06-03

No results posted yet for this study

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.

Conditions

  • Renal Stones
  • Retrograde Intrarenal Surgery
  • Ureteral Access Sheath Placement

Interventions

DRUG

Placebo Capsule

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

DRUG

Tamsulosin

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

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Beni-Suef University

    lead OTHER

Principal Investigators

  • Hany F Badawy, MD · Faculty of Medicine, Beni-Suef University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-06
Primary Completion
2027-04-30
Completion
2027-05-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07623876 on ClinicalTrials.gov