Intravesical Aminophylline to Facilitate Ureteroscopic Access in Children With Distal Ureteral Stones.

NCT07617896 | Recruiting Phase 2

• 1 other identifier: FMBSUREC05052026Badawy
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate whether intravesical aminophylline can facilitate semi-rigid ureteroscopic access in children with distal ureteral stones when the first gentle attempt to enter the ureter is unsuccessful. Children scheduled for semi-rigid ureteroscopy for distal ureteral stones will first undergo the standard gentle attempt to pass the ureteroscope through the ureteric orifice and intramural ureter. If access is achieved, the child will continue standard treatment and will not be randomized. If access is not achieved, the child will be randomized during the operation to receive either intravesical aminophylline or intravesical normal saline placebo. The study solution will be instilled into the bladder for approximately 5 minutes, then drained, and a second gentle ureteroscopic access attempt will be made. The main outcome is successful same-session passage of the intended semi-rigid ureteroscope without balloon dilation. The study will also assess the need for JJ stenting and deferred ureteroscopy, same-session stone treatment, operative outcomes, complications, and early aminophylline-related safety.

Conditions

Pediatric Urolithiasis; Distal Ureteral Stone; Ureteral Calculi

Keywords

Intravesical Aminophylline; Semi-Rigid Ureteroscopy; Pediatric Ureteroscopy; Ureteroscopic Access; Distal Ureteral Stones

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants With Successful Same-Session Semi-Rigid Ureteroscopic Access Without Balloon Dilation

  Successful access is defined as passage of the intended semi-rigid ureteroscope through the ureteric orifice and intramural ureter after study solution instillation, without the need for balloon dilation. The outcome will be reported as the proportion of randomized participants achieving successful access in each study arm.

  Intraoperative, immediately after 5-minute intravesical study solution instillation during the index ureteroscopy procedure.

Secondary Outcomes (5)

• Proportion of Participants Requiring Balloon Dilation

  Intraoperative, during the index ureteroscopy procedure

• Total Operative Time

  Intraoperative, during the index ureteroscopy procedure

• Proportion of Participants Requiring Postoperative Ureteral Stenting

  At the end of the index ureteroscopy procedure

• Proportion of Participants With Postoperative Complications

  From the end of surgery up to 3 months after the index procedure

• Proportion of Participants With Stone-Free Status

  Up to 3 months after the index procedure

Study Arms (2)

Intravesical Aminophylline

EXPERIMENTAL

Children with failed initial gentle semi-rigid ureteroscopic access will receive intravesical aminophylline 0.5 mg/kg diluted in 0.9% normal saline to a total volume of 50 mL. The solution will dwell in the bladder for approximately 5 minutes before drainage and a second gentle ureteroscopic access attempt.

Drug: Aminophylline

Intravesical Normal Saline Placebo

PLACEBO COMPARATOR

Children with failed initial gentle semi-rigid ureteroscopic access will receive 50 mL of intravesical 0.9% normal saline placebo. The solution will dwell in the bladder for approximately 5 minutes before drainage and a second gentle ureteroscopic access attempt.

Drug: Normal Saline Placebo

Interventions

Aminophylline DRUG

Aminophylline will be administered intravesically at a dose of 0.5 mg/kg, diluted in 0.9% normal saline to a fixed total volume of 50 mL. The solution will be instilled through a urethral catheter, retained in the bladder for approximately 5 minutes, then drained before a second gentle semi-rigid ureteroscopic access attempt.

Intravesical Aminophylline

Normal Saline Placebo DRUG

A 50 mL volume of 0.9% normal saline placebo will be instilled intravesically through a urethral catheter, retained in the bladder for approximately 5 minutes, then drained before a second gentle semi-rigid ureteroscopic access attempt.

Intravesical Normal Saline Placebo

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children older than 2 years and younger than 18 years.
• Single unilateral lower/distal ureteral stone confirmed by low-dose non-contrast computed tomography according to local policy.
• Stone size 5 to 15 mm.
• Candidate for definitive treatment by semi-rigid ureteroscopy.
• Sterile urine culture before surgery, or previously positive urine culture that has been properly treated before intervention.
• Intraoperative failed initial gentle negotiation of the ureteric orifice/intramural ureter according to the study definition.
• Written informed consent from the parent or legal guardian, with child assent when appropriate.

You may not qualify if:

• Known hypersensitivity to aminophylline, theophylline, or ethylenediamine.
• Use of oral or intravenous aminophylline or theophylline within the previous 24 hours.
• Pre-existing ipsilateral JJ ureteral stent.
• Stone peeping at the ureteric orifice.
• Congenital or acquired abnormality that may affect distal ureteric access, such as ureterocele, obstructive megaureter, distal ureteric stricture, previous ureteric reimplantation, or previous ipsilateral ureteral reconstruction.
• Known bladder dysfunction or conditions likely to affect normal bladder capacity.
• Multiple ipsilateral ureteral stones or associated renal stones requiring flexible ureteroscopy or a ureteral access sheath strategy.
• Febrile urinary tract infection, pyonephrosis, sepsis, or any case requiring urgent decompression instead of definitive ureteroscopy.
• Cardiac disease, arrhythmia, uncontrolled hypertension, hyperthyroidism, epilepsy or seizure disorder, or significant hepatic impairment.
• Inability to complete follow-up.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Department of Urology- Beni-Suef University Hospitals

Banī Suwayf, Beni Suweif Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Ureteral Calculi

Interventions

Aminophylline

Condition Hierarchy (Ancestors)

Ureterolithiasis; Ureteral 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

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Theophylline; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Hany F Badawy, MD

  Faculty of medicine BeniSuef University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hany F Badawy, Md

CONTACT

+201149525028; HANYFATHY86@GMAIL.COM

Ahmed Gmal, MD

CONTACT

+20 11 18206022; Drhanyfathy86@GMAIL.COM

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study solution will be prepared by a clinician or pharmacist not involved in surgery or postoperative assessment. The surgeon/investigator, anesthetist/care provider, participant and family, and postoperative outcomes assessor will remain blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology, Faculty of Medicine, Beni-Suef University

Model Details: Children with failed initial gentle semi-rigid ureteroscopic access will be randomized intraoperatively in a 1:1 ratio to receive either intravesical aminophylline or intravesical normal saline placebo before a second gentle access attempt.

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 1, 2026
• Study Start: May 9, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)