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Clinical Trials/NCT06728943
NCT06728943RecruitingNot Applicable

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

Al-Azhar University1 site in 1 country300 target enrollmentStarted: December 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
300
Locations
1
Primary Endpoint
Success rate of Ureteral access and Scoping of the stones after Intra-ureteral instillation of Aminophylline without Ballon Dilatation

Study Overview

Brief Summary

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

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) .

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

The group of patients with failed stone accessibility by semi-rigid ureteroscopy

Experimental

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.

Intervention: ureteral dilatation (Procedure)

Outcomes

Primary Outcomes

Success rate of Ureteral access and Scoping of the stones after Intra-ureteral instillation of Aminophylline without Ballon Dilatation

Time Frame: from the start of ureteroscopy entrance to the end of the procedure

Success rate of Ureteral access and Scoping of the stones after Intra-ureteral instillation of Aminophylline without Ballon Dilatation

Secondary Outcomes

  • Success of complete extraction of stones(from the start of ureteroscopic entrance to the end of the procedure)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohamed Fawzy Abd Elfattah Salman

lecturer of urology

Al-Azhar University

Study Sites (1)

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