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

In this study we will test the effect of local intraureteric aminophylline instillation through Ureteric stent and Reaching stone without the need of ballon dilataion

Study Overview

• Status: Recruiting
• Conditions: Ureteric Stone; Stone Ureter; Ureterocopic Lithotripsy
• Intervention / Treatment: Procedure: ureteral dilatation

Detailed Description

Urolithiasis is a significantly common disease globally, despite the notable difference in the rate of occurrence based on various factors like gender, climate, diet, and other risk factors. There has been a yearly increase in the prevalence of stone occurrence in people above the age of 30 for all genders. (1).

The EAU recommends URS as the first-line treatment for stones either in the proximal or distal ureter measuring >10 mm; for <10 mm, either URS or SWL can be selected for first-line management. URS is associated with a higher SFR and a better clinical outcome when compared to SWL (1,6.7.8) .

During ureteroscopy, the use of guide wire and ureteroscope itself in the procedures can lead to complications like ureteral spasm. Agents like lidocaine gel, intravenous buscopan and aminophylline can be used to relieve spasm and increase the success of treatment. Aminophylline is used for the treatment of acute phase of renal colic. (2) .

Aminophylline, a methyl xanthine and theophylline derivative, relaxes smooth muscle by increasing the concentration of intracellular 3",5"-cyclic adenosine monophosphate (cAMP), and cyclic guanosine mono- phosphate (cGMP) and activating protein kinase A. In addition, aminophylline alleviates inflammation by decreasing the production of leukotrienes and TNFα. (3) .

Aminophylline is a drug having combination of theophylline and ethylenediamine in a ratio of 2:1. Theophylline helps in peristalsis of ureter and verapamil causes an acute dilation of proximal ureter. The capability to alter the diameter of ureter and the peristaltic activity helps in ureteroscopy. Aminophylline is a cheap, safe, with minimum side effects. (3) .

In a randomized controlled trial, performed by (Shabayek et al., 2022) on the effect of intravesical aminophylline instillation after failure of advancing semi-rigid ureteroscope through the ureteric orifice without endodilatation. Intravesical aminophylline instillation was effective in reducing intraureteral pressure at the lower ureter and can be used as an alternative to balloon dilatation prior to ureteroscopic management of distal ureteric stones.

In a study performed by (Lubana et al., 2024), The use of local aminophylline during ureteroscopic stone treatment has been found to be highly useful and effective in reducing the need of stents and secondary surgery, decreased pain, and increased success rate.

In this study we will test the effect of local intraureteric aminophylline instillation through Ureteric stent and Reaching stone without the need of ballon dilataion

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Fawzy Salman, MD; Phone Number: +201111788996; Email: prof_mohamed_fawzy@yahoo.com
• Study Contact Backup: Name: Mohamed Fawzy Mohamed Fawzy Salman, MD; Phone Number: +201111788996 +201111788996; Email: prof_mohamed_fawzy@yahoo.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Al-Azhar university, faculty of medicine, the urology department
    • Contact: Alhussien university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The study will include patients with failed stone accessibility by semi-rigid ureteroscopy.

Exclusion Criteria:

• Child age group
• Pre stented patients
• Contraindications to aminophylline (hypersensitivity to drug components, pregnancy or lactation ,…)
• Contraindications to ureteroscopy (active urinary tract infection - Contraindications to general or spinal anesthesia - Uncorrected bleeding disorders)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: The group of patients with failed stone accessibility by semi-rigid ureteroscopy; Direct semi-rigid ureteroscopy will initially be attempted without endodilatation (KARL STORZ, 43 cm, 6°, 7 Fr.). On failure to advance the semi-rigid ureteroscope through the ureter, intra-ureteric instillation of 20 ml of aminophylline (250 mg/10 mL) through ureteric stent and another trial to pass the same scope will be done after 10 minutes of intra-ureteral aminophylline instillation.

Procedure: ureteral dilatation; Direct semi-rigid ureteroscopy will initially be attempted without endodilatation (KARL STORZ, 43 cm, 6°, 7 Fr.). On failure to advance the semi-rigid ureteroscope through the ureter, intra-ureteric instillation of 20 ml of aminophylline (250 mg/10 mL) through ureteric stent and another trial to pass the same scope will be done after 10 minutes of intra-ureteral aminophylline instillation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of Ureteral access and Scoping of the stones after Intra-ureteral instillation of Aminophylline without Ballon Dilatation	Success rate of Ureteral access and Scoping of the stones after Intra-ureteral instillation of Aminophylline without Ballon Dilatation	from the start of ureteroscopy entrance to the end of the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success of complete extraction of stones	Success of complete extraction of stones after intraureteric injection of aminophylline	from the start of ureteroscopic entrance to the end of the procedure

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: December 8, 2024
• First Submitted That Met QC Criteria: December 8, 2024
• First Posted (Estimated): December 11, 2024

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 8, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: ureteroscopy; stone ureter; ureteral dilatation; failed ureteroscopy
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Pathological Conditions, Anatomical; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Urinary Calculi; Ureteral Diseases; Ureteral Calculi; Ureterolithiasis; Calculi
• Other Study ID Numbers: Intra-Ureteric Aminophylline

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No