Flexible Ureteroscopy for Large Renal Stones in Children

NCT07780409 | Completed

• 1 other identifier: FMASU MS 391/2025
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective single-arm interventional study evaluated the efficacy and safety of flexible ureteroscopy for the treatment of large renal stones measuring 2 cm or more in pediatric patients. All enrolled participants underwent flexible ureteroscopic stone disintegration using a single-use flexible ureteroscope and Holmium laser lithotripsy. The study was designed to assess whether this minimally invasive approach could provide effective stone clearance with acceptable perioperative safety in children with large renal stones.

Conditions

Kidney Calculi

Keywords

Pediatric Urolithiasis; Renal Stones; Large Renal Stones; Flexible Ureteroscopy; Flexible Ureterorenoscopy; Single-Use Flexible Ureteroscope; Laser Lithotripsy; Holmium:YAG Laser

Outcome Measures

Primary Outcomes (1)

• Stone-Free Rate After Flexible Ureteroscopic Stone Disintegration

  Stone-free status was assessed by computed tomography of the urinary tract (CTUT) after flexible ureteroscopic stone disintegration. The proportion of participants meeting the study-defined criteria for stone-free status was recorded.

  1 month after the procedure

Secondary Outcomes (1)

• Operative Time

  Intraoperatively

Study Arms (1)

Flexible Ureteroscopic Stone Disintegration

EXPERIMENTAL

Pediatric patients with large renal stones (≥2 cm) underwent flexible ureteroscopic stone disintegration using a 7.5-Fr single-use flexible ureteroscope and Holmium:YAG laser lithotripsy. A ureteral access sheath was used when feasible, and a double-J ureteral stent was inserted at the end of the procedure.

Procedure: Flexible Ureteroscopic Stone Disintegration

Interventions

Flexible Ureteroscopic Stone Disintegration PROCEDURE

Flexible ureteroscopy was performed using a 7.5-Fr single-use flexible ureteroscope. Renal stones were fragmented with a Holmium:YAG laser. A ureteral access sheath was used when feasible, and a double-J ureteral stent was placed at the end of the procedure.

Flexible Ureteroscopic Stone Disintegration

Eligibility Criteria

• Age: 0 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients diagnosed with renal stones.
• Renal stone size ≥2 cm.
• Age younger than 14 years.

You may not qualify if:

• Uncontrolled urinary tract infection.
• Impaired renal function.
• Abnormal anatomical location of the kidney.
• Congenital renal or ureteric anomalies.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, 11511, Egypt

Location

MeSH Terms

Conditions

Kidney Calculi; Nephrolithiasis

Condition Hierarchy (Ancestors)

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking was used because all participants received the same surgical intervention.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Urology

Model Details: All enrolled pediatric patients with large renal stones underwent flexible ureteroscopic stone disintegration using a single-use flexible ureteroscope and Holmium:YAG laser.

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 21, 2026
• Study Start: August 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: August 21, 2026

Record last verified: 2026-08

Locations

EG (1)