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NCT Number: NCT06728943

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Azhar university, faculty of medicine, the urology department

Cairo, Egypt

Location status: Recruiting

Location contact

Alhussien university hospital

CONTACT

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ureteral dilatation

Procedure

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.

Primary outcomes

  1. 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

  1. Success of complete extraction of stones

    Time frame: from the start of ureteroscopic entrance to the end of the procedure

    Success of complete extraction of stones after intraureteric injection of aminophylline

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Fawzy Mohamed Fawzy Salman, MD

CONTACT

[email protected]

+201111788996 ext. +201111788996

Mohamed Fawzy Salman, MD

CONTACT

[email protected]

+201111788996

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Dec 11, 2024
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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