Intra-ureteric Aminophylline Instillation on Flexible Ureteroscopy Procedure

Ain Shams University

Status: Enrolling

Conditions: Ureteric Injury; Stones, Kidney

Treatments: Device: Sequential teflon dilator usage prior to ureteric access sheath placement in flexible uretroscopy; Other: Aminophylline instillation and Ureteral dilators together; Drug: Usage of Aminophylline prior to ureteric dilatation in Flexible uretroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT06830577

Intraureteric aminophylline

Details and patient eligibility

About

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.

Full 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)

Enrollment: 129 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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129 participants in 3 patient groups

Group A: Aminophylline Group: Intra-ureteric instillation of aminophylline

Experimental group

Description:

a ureteric catheter 6 Fr will be used for instillation of normal saline supplemented with aminophylline 250 mg/10 mL at three points (Pelvi-ureteric junction, upper sacroiliac joint level and proximal to uretero-vesical junction by 5 cm) then wait for 5 minutes

Treatment:

Drug: Usage of Aminophylline prior to ureteric dilatation in Flexible uretroscopy

Group B: Ureteral Dilator Group: Traditional ureteral dilators

Active Comparator group

Description:

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

Treatment:

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

Group C: Combination Group: Aminophylline instillation and Ureteral dilators

Other group

Description:

Aminophylline will be instilled as in group (A) then followed by traditional ureteral dilatation as in group (B)

Treatment:

Drug: Usage of Aminophylline prior to ureteric dilatation in Flexible uretroscopy

Other: Aminophylline instillation and Ureteral dilators together

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