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

NCT06728943 | Recruiting DMC

• 1 other identifier: Intra-Ureteric Aminophylline
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

Ureterocopic Lithotripsy; Stone Ureter; Ureteric Stone

Keywords

ureteroscopy; stone ureter; ureteral dilatation; failed ureteroscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Success of complete extraction of stones

  from the start of ureteroscopic entrance to the end of the procedure

Study Arms (1)

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.

Procedure: ureteral dilatation

Interventions

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

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

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Ureterolithiasis

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Central Study Contacts

Mohamed Fawzy Mohamed Fawzy Salman, MD

CONTACT

+201111788996; prof_mohamed_fawzy@yahoo.com

Mohamed Fawzy Salman, MD

CONTACT

+201111788996; prof_mohamed_fawzy@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of urology

Model Details: 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.

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: December 11, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 11, 2024

Record last verified: 2024-12

Locations

EG (1)