Intra-ureteric Aminophylline Instillation on Flexible Ureteroscopy Procedure

Official title

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

Overview

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)

Interventions

• Drug Usage of Aminophylline prior to ureteric dilatation in Flexible uretroscopy
  Intraureteric aminophylline installation prior to ureteric dilatation
• Device Sequential teflon dilator usage prior to ureteric access sheath placement in flexible uretroscopy
  traditional ureteral dilators will be used. We will start by ureteral dilator 6 fr and gradually increase the size up to 12 Fr
• Other Aminophylline instillation and Ureteral dilators together
  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

Primary outcome measures

• The successful placement of ureteric access sheath [Time frame: intraoperative application of the access sheath]

Secondary outcome measures (1)

• successful stone clearance [Time frame: 3 weeks postoperative follow up with urinary tract multislice CT]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Ain Shams University Hospitals — Cairo

Publications

• 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. PMID 35618855

Identifiers

NCT: NCT06830577 · Intraureteric aminophylline

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗