Clinical trial NCT06830577: Intra-ureteric Aminophylline Instillation on Flexible Ureteroscopy Procedure
Official title: Efficacy of Intra-ureteric Aminophylline Instillation on Flexible Ureteroscopy Procedure: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stones, Kidney
Ureteric Injury
Keywords: Aminophylline
Ureteric access sheath
ureteric injury
Flexible Uretroscopy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: in this study we are going to evaluate the efficacy of intra-ureteric aminophylline instillation in facilitating ureteric access sheath placement prior to flexible ureteroscopy in reducing ureteric injury rates.

Detailed description: Urolithiasis (kidney and ureteral stones) is a common urologic condition with increasing prevalence. Flexible ureteroscopy (FURS) is a minimally invasive technique widely used for upper ureteric and renal stones. Aminophylline, a methylxanthine derivative, has been shown to relax smooth muscles and was previously used intravesically to facilitate rigid ureteroscopy with reduced complications. This study aims to assess whether intra-ureteric aminophylline instillation improves the ease of ureteral access sheath (UAS) placement during FURS and reduces ureteric injuries.

patients will be divided into 3 groups:

1. Group A (Aminophylline Group): Intra-ureteric instillation of aminophylline
2. Group B (Ureteral Dilator Group): Traditional ureteral dilators
3. Group C (Combination Group): Aminophylline instillation + Ureteral dilators follow up of the patients will be through the success rate or failure of ureteric access sheath placement, operative time, bleeding, intra/postoperative complications and stone clearance (3-week follow-up with CT scan)

Eligibility 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)

Primary outcomes:
measure: The successful placement of ureteric access sheath
timeFrame: intraoperative application of the access sheath
Secondary outcomes:
measure: successful stone clearance
timeFrame: 3 weeks postoperative follow up with urinary tract multislice CT
Other outcomes:
Locations:
city: CAiro
country: Egypt
facility: Ain Shams University Hospitals
state: Abassia
Study officials:
affiliation: Ain Shams University
name: Younan Samir, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shabayek M, Osman T, Wahb M, Elmoazen M, Osman D, Saafan A. Intravesical aminophylline instillation as an alternative for balloon dilatation prior to semi-rigid ureteroscopic management of distal ureteral stones. World J Urol. 2022 Jul;40(7):1805-1811. doi: 10.1007/s00345-022-04039-7. Epub 2022 May 26.