Intra-ureteric Aminophylline Instillation on Flexible Ureteroscopy Procedure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2026-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Intra-Ureteric Aminophylline Installation After Failed Stone Accessibility by Semi-rigid Ureteroscopy. Prospective Trial

NCT06728943

Ureterocopic Lithotripsy Stone Ureter Ureteric Stone

RECRUITING NA

Aminophylline Infusion on Pain Intensity After Ureterocopic Lithotripsy

NCT05705050

Aminophylline Pain Ureterocopic Lithotripsy

COMPLETED NA

Ultrasound Guided Ureteroscopy and Ureteric Stones

NCT03404986

Ureteric Stone

COMPLETED NA

Ultra-Mini Versus Standard Percutaneous Nephrolithotomy For Management Of Renal Calculi. A Randomized Controlled Trial.

NCT04764071

Stone, Kidney

UNKNOWN PHASE3

Ultra Mini Percutaneous Nephrolithotomy VS Stented Extracorporeal Shock Wave Lithotripsy for Stone Management

NCT05697341

Renal Stone

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stones, Kidney Ureteric Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

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

Group Type EXPERIMENTAL

Usage of Aminophylline prior to ureteric dilatation in Flexible uretroscopy

Intervention Type DRUG

Intraureteric aminophylline installation prior to ureteric dilatation

Group B: Ureteral Dilator Group: Traditional ureteral dilators

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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

Group C: Combination Group: Aminophylline instillation and Ureteral dilators

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

Group Type OTHER

Usage of Aminophylline prior to ureteric dilatation in Flexible uretroscopy

Intervention Type DRUG

Intraureteric aminophylline installation prior to ureteric dilatation

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

Intervention Type DEVICE

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

Aminophylline instillation and Ureteral dilators together

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Usage of Aminophylline prior to ureteric dilatation in Flexible uretroscopy

Intraureteric aminophylline installation prior to ureteric dilatation

Intervention Type DRUG

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

Intervention Type DEVICE

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Intraureteric Aminophylline instillation prior to access sheath insertion ureteric teflon dilators prior to access sheath insertion combination of aminophylline instillation and ureteric teflon dilators prior to access sheath insertion

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes