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NCT Number: NCT06830577

Intra-ureteric Aminophylline Instillation on Flexible Ureteroscopy Procedure

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University Hospitals

Cairo, Abassia, 11517, Egypt

Location status: Recruiting

Location contact

Ali Khaled Mohammed Ali M. Dr. Ali Khaled, MSc.

CONTACT

[email protected]

201099978174

Mahmoud A. Dr. Mahmoud Ahmed, PhD.

PRINCIPAL_INVESTIGATOR

Younan R. Lecturer Dr. Younan Ramsis Samir, PhD.

CONTACT

201255511

Younan R. Samir, PhD.

PRINCIPAL_INVESTIGATOR

About this study

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:

  • Group A (Aminophylline Group): Intra-ureteric instillation of aminophylline
  • Group B (Ureteral Dilator Group): Traditional ureteral dilators
  • 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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Upper ureteric stones or renal stones < 2 cm

Exclusion criteria

  • Ureteric strictures.
  • anatomic renal disorders
  • functional renal disorders
  • Urinary tract infection.
  • Coagulopathy and uncorrected bleeding disorders.
  • Prior DJ stenting
  • 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)

Treatment and study plan

Usage of Aminophylline prior to ureteric dilatation in Flexible uretroscopy

Drug

Intraureteric aminophylline installation prior to ureteric dilatation

Other names: Intraureteric Aminophylline instillation prior to access sheath insertion

Sequential teflon dilator usage prior to ureteric access sheath placement in flexible uretroscopy

Device

traditional ureteral dilators will be used. We will start by ureteral dilator 6 fr and gradually increase the size up to 12 Fr

Other names: ureteric teflon dilators prior to access sheath insertion

Aminophylline instillation and Ureteral dilators together

Other

Aminophylline will be instilled as in group (A) then followed by traditional ureteral dilatation as in group (B) prior to placing the ureteric access sheath

Other names: combination of aminophylline instillation and ureteric teflon dilators prior to access sheath insertion

Primary outcomes

  1. The successful placement of ureteric access sheath

    Time frame: intraoperative application of the access sheath

    we will assess the successful placement of ureteric access sheath in patients (that the access sheath is passed on the guide wire till the pelviureteric junction portion of the ureter after the usage of intraureteric aminophylline or teflon dilators or the usage of both.

Secondary outcomes

  1. successful stone clearance

    Time frame: 3 weeks postoperative follow up with urinary tract multislice CT

    the stone free rate following intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Ali Khaled Mohammed Ali Dr. Ali Khaled, MSc.

CONTACT

[email protected]

+201099978174

Younan Samir, PhD

CONTACT

[email protected]

+201201255511

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Efficacy of Intra-ureteric Aminophylline Instillation on Flexible Ureteroscopy Procedure: A Randomized Controlled Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2025
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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