Intra-ureteric Aminophylline Instillation on Flexible Ureteroscopy Procedure

NCT06830577 | Recruiting

• 1 other identifier: Intraureteric aminophylline
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

in this study we are going to evaluate the efficacy of intra-ureteric aminophylline instillation in facilitating ureteric access sheath placement prior to flexible ureteroscopy in reducing ureteric injury rates.

Conditions

Stones, Kidney; Ureteric Injury

Keywords

Aminophylline; Ureteric access sheath; ureteric injury; Flexible Uretroscopy

Outcome Measures

Primary Outcomes (1)

• The successful placement of ureteric access sheath

  we will assess the successful placement of ureteric access sheath in patients (that the access sheath is passed on the guide wire till the pelviureteric junction portion of the ureter after the usage of intraureteric aminophylline or teflon dilators or the usage of both.

  intraoperative application of the access sheath

Secondary Outcomes (1)

• successful stone clearance

  3 weeks postoperative follow up with urinary tract multislice CT

Study Arms (3)

Group A: Aminophylline Group: Intra-ureteric instillation of aminophylline

EXPERIMENTAL

a ureteric catheter 6 Fr will be used for instillation of normal saline supplemented with aminophylline 250 mg/10 mL at three points (Pelvi-ureteric junction, upper sacroiliac joint level and proximal to uretero-vesical junction by 5 cm) then wait for 5 minutes

Drug: Usage of Aminophylline prior to ureteric dilatation in Flexible uretroscopy

Group B: Ureteral Dilator Group: Traditional ureteral dilators

ACTIVE COMPARATOR

traditional ureteral dilators will be used. We will start by ureteral dilator 6 fr and gradually increase the size up to 12 Fr

Device: Sequential teflon dilator usage prior to ureteric access sheath placement in flexible uretroscopy

Group C: Combination Group: Aminophylline instillation and Ureteral dilators

OTHER

Aminophylline will be instilled as in group (A) then followed by traditional ureteral dilatation as in group (B)

Drug: Usage of Aminophylline prior to ureteric dilatation in Flexible uretroscopy; Device: Sequential teflon dilator usage prior to ureteric access sheath placement in flexible uretroscopy; Other: Aminophylline instillation and Ureteral dilators together

Interventions

Usage of Aminophylline prior to ureteric dilatation in Flexible uretroscopy DRUG

Intraureteric aminophylline installation prior to ureteric dilatation

Also known as: Intraureteric Aminophylline instillation prior to access sheath insertion

Group A: Aminophylline Group: Intra-ureteric instillation of aminophylline; Group C: Combination Group: Aminophylline instillation and Ureteral dilators

Sequential teflon dilator usage prior to ureteric access sheath placement in flexible uretroscopy DEVICE

traditional ureteral dilators will be used. We will start by ureteral dilator 6 fr and gradually increase the size up to 12 Fr

Also known as: ureteric teflon dilators prior to access sheath insertion

Group B: Ureteral Dilator Group: Traditional ureteral dilators; Group C: Combination Group: Aminophylline instillation and Ureteral dilators

Aminophylline instillation and Ureteral dilators together OTHER

Aminophylline will be instilled as in group (A) then followed by traditional ureteral dilatation as in group (B) prior to placing the ureteric access sheath

Also known as: combination of aminophylline instillation and ureteric teflon dilators prior to access sheath insertion

Group C: Combination Group: Aminophylline instillation and Ureteral dilators

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Upper ureteric stones or renal stones \< 2 cm

You may not qualify if:

• Ureteric strictures.
• anatomic renal disorders
• functional renal disorders
• Urinary tract infection.
• Coagulopathy and uncorrected bleeding disorders.
• Prior DJ stenting
• any contraindication for aminophylline use: (hypersensitivity to theophylline, ethylenediamine, or any component of the drug formulation, pregnancy or lactation, active peptic ulcer, presence of cardiologic diseases, presence of neurologic diseases, presence of renal impairment and presence of hepatic dysfunction)

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Abassia, 11517, Egypt

RECRUITING

Related Publications (1)

• Shabayek M, Osman T, Wahb M, Elmoazen M, Osman D, Saafan A. Intravesical aminophylline instillation as an alternative for balloon dilatation prior to semi-rigid ureteroscopic management of distal ureteral stones. World J Urol. 2022 Jul;40(7):1805-1811. doi: 10.1007/s00345-022-04039-7. Epub 2022 May 26.

  PMID: 35618855 BACKGROUND

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Younan Samir, PhD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Khaled Mohammed Ali Dr. Ali Khaled, MSc.

CONTACT

+201099978174; ali.khaled94@gmail.com

Younan Samir, PhD

CONTACT

+201201255511; dr_yona@live.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 17, 2025
• Study Start: March 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)