Aminophylline to help ureteric access sheath placement during flexible ureteroscopy
Official title: Efficacy of Intra-ureteric Aminophylline Instillation on Flexible Ureteroscopy Procedure: A Randomized Controlled Study
Run by Ain Shams University · NCT06830577 · Data updated 2026-11-12
This trial will test whether putting aminophylline into the ureter before flexible ureteroscopy helps place the ureteric access sheath and reduces ureteric injuries for patients with upper ureter or kidney stones smaller than 2 cm.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 129 (estimated) |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo, Abassia) |
| Status | Recruiting |
| Started | March 1, 2025 |
| Main results expected | January 1, 2026 |
| Study ends | February 1, 2026 |
| Registry record updated | June 12, 2025 |
| Trial ID | NCT06830577 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with upper ureteric or renal stones under 2 cm who do not have active urinary infection, ureteric strictures, prior DJ stenting, significant renal or hepatic impairment, or any contraindication to aminophylline.
✕Probably not a fit
Patients with ureteric strictures, anatomic or functional renal disorders, active infection, coagulopathy, prior stenting, or contraindications to aminophylline (including pregnancy, certain cardiac, neurologic, renal or hepatic diseases) are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Urolithiasis of the upper ureter and kidney is commonly treated with flexible ureteroscopy (FURS) using a ureteric access sheath (UAS). Aminophylline, a smooth-muscle relaxant, has been used previously to ease endoscopic procedures and may facilitate UAS placement. In this interventional trial, patients are assigned to one of three groups: intra-ureteric aminophylline instillation, traditional sequential teflon ureteral dilators, or a combination of both, with outcomes recorded during FURS. Primary outcomes include success or failure of UAS placement, operative time, bleeding, intra/postoperative complications, and stone clearance assessed by CT at three weeks at Ain Shams University Hospitals in Cairo.
Why it matters
Potential benefit: If successful, this approach could make sheath placement easier, reduce ureteric injuries and complications, and shorten operative time for patients undergoing FURS.
How similar studies have gone: Aminophylline has previously been used intravesically to facilitate rigid ureteroscopy with reduced complications, but intra-ureteric use specifically to aid UAS placement during flexible ureteroscopy is relatively novel with limited prior data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Upper ureteric stones or renal stones \< 2 cm Exclusion Criteria: 1. Ureteric strictures. 2. anatomic renal disorders 3. functional renal disorders 4. Urinary tract infection. 5. Coagulopathy and uncorrected bleeding disorders. 6. Prior DJ stenting 7. any contraindication for aminophylline use: (hypersensitivity to theophylline, ethylenediamine, or any component of the drug formulation, pregnancy or lactation, active peptic ulcer, presence of cardiologic diseases, presence of neurologic diseases, presence of renal impairment and presence of hepatic dysfunction)
Where it's running
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Ain Shams University Hospitals
Cairo, Abassia, Egypt Recruiting
Study contacts
- Principal investigator: Younan Samir, PhD — Ain Shams University
- Study coordinator: Ali Khaled Mohammed Ali Dr. Ali Khaled, MSc.
- Email: ali.khaled94@gmail.com
- Phone: +201099978174
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.