Tamsulosin and Intraureteral Aminophylline for Ureteral Access During RIRS (NCT07623876) | Clinical Trial Compass
RecruitingPhase 2
Tamsulosin and Intraureteral Aminophylline for Ureteral Access During RIRS
Egypt322 participantsStarted 2026-05-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.