Intravesical aminophylline instillation as an alternative for balloon dilatation prior to semi-rigid ureteroscopic management of distal ureteral stones.
M Shabayek, T Osman, M Wahb...
https://pubmed.ncbi.nlm.nih.gov/35618855Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06830577
Efficacy of Intra-ureteric Aminophylline Instillation on Flexible Ureteroscopy Procedure: A Randomized Controlled Study
Led by Ain Shams University · Updated on 2025-06-12
129
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether intra-ureteric aminophylline instillation can help in placing the ureteric access sheath more easily during flexible ureteroscopy for kidney and ureteral stones. The study focuses on reducing ureteric injury rates and improving the procedure's success in patients with stones smaller than 2 cm. Aminophylline is being studied because it relaxes smooth muscles and may reduce complications compared to traditional methods. Participants will be divided into three groups: one receiving aminophylline instillation into the ureter, another using traditional ureteral dilators starting at 6 Fr and increasing to 12 Fr, and a third group receiving both aminophylline instillation followed by ureteral dilation. Aminophylline is applied at three points within the ureter using a catheter, with a 5-minute wait before proceeding. The study compares these approaches during flexible ureteroscopy. Throughout the study, researchers will track the success or failure of ureteric access sheath placement, the length of surgery, bleeding, any complications during or after the procedure, and stone clearance after three weeks using a CT scan. Participants will be monitored closely to assess these outcomes and ensure safety. The study is expected to run from March 2025 to February 2026.
CONDITIONS
Brief Title
Intra-ureteric Aminophylline Instillation on Flexible Ureteroscopy Procedure
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Presence of upper ureteric stones or renal stones smaller than 2 cm
You will not qualify if you...
- Presence of ureteric strictures
- Anatomic renal disorders
- Functional renal disorders
- Current urinary tract infection
- Coagulopathy or uncorrected bleeding disorders
- Prior DJ stenting
- Contraindications to aminophylline use such as hypersensitivity to theophylline or ethylenediamine, pregnancy or lactation, active peptic ulcer, cardiologic diseases, neurologic diseases, renal impairment, or hepatic dysfunction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single procedure day
Participants receive flexible ureteroscopy with one of three interventions: intra-ureteric aminophylline instillation, traditional ureteral dilators, or a combination of both, to facilitate ureteric access sheath placement.
1 visit (in-person)
Follow-up
Duration - 3 weeks
Participants are monitored for operative outcomes, complications, and stone clearance with a follow-up CT scan 3 weeks after the procedure.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Ain Shams University Hospitals
Cairo, Abassia, Egypt, 11517
Actively Recruiting
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Research Team
A
Ali Khaled Mohammed Ali Dr. Ali Khaled, MSc.
Y
Younan Samir, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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