Dusting vs Fragmentation Laser Cystolithotripsy for Pediatric Bladder Stones

NCT07623980 | Recruiting

• 2 other identifiers: FMBSUREC05052026BadawyDFFMBSUREC/05052026/Badawy
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Bladder stones are a clinically relevant pediatric urological condition that may require endoscopic treatment. Transurethral Holmium:YAG laser cystolithotripsy is a minimally invasive option for selected children with bladder stones. This prospective randomized trial will compare two Holmium:YAG laser strategies during transurethral cystolithotripsy in children with a single bladder stone less than 3 cm: dusting and fragmentation. Children will be randomized to undergo laser dusting or laser fragmentation during transurethral cystolithotripsy. The primary outcome is total operative time. Secondary outcomes include laser time, need for active fragment extraction, endoscopic stone-free status at the end of the procedure, ultrasound-assessed stone-free status during follow-up, intraoperative complications, postoperative urinary symptoms, urinary tract infection, need for postoperative catheterization, and hospital stay.

Conditions

Bladder Calculi; Pediatric Bladder Stones; Pediatric Urolithiasis

Keywords

Transurethral cystolithotripsy; Dusting; Holmium:YAG laser; Fragmentation; Bladder stone surgery

Outcome Measures

Primary Outcomes (1)

• Total Operative Time

  Total operative time will be measured in minutes from insertion of the endoscope into the urethra until completion of bladder stone clearance and termination of the procedure, including active fragment retrieval when required.

  During the index transurethral cystolithotripsy procedure

Secondary Outcomes (4)

• Laser Time

  During the index transurethral cystolithotripsy procedure

• Need for Active Fragment Extraction

  During the index transurethral cystolithotripsy procedure

• Endoscopic Stone-Free Status at the End of the Procedure

  At the end of the index transurethral cystolithotripsy proced

• Postoperative Hematuria

  From the end of the procedure to 1 month postoperatively

Study Arms (2)

Dusting

EXPERIMENTAL

Participants will undergo transurethral Holmium:YAG laser cystolithotripsy using a dusting strategy with low pulse energy . The planned settings are 0.5-0.8 J and 10-15 Hz, aiming to reduce the bladder stone into fine particulate debris and tiny fragments with minimal need for active fragment extraction.

Procedure: Dusting Holmium:YAG Laser Cystolithotripsy

Fragmentation

ACTIVE COMPARATOR

Participants will undergo transurethral Holmium:YAG laser cystolithotripsy using a fragmentation strategy with higher pulse energy. The planned settings are 1.0 J and 6-10 Hz, aiming to produce visible extractable stone fragments, approximately 2-5 mm, with active fragment removal when needed.

Procedure: Fragmentation Holmium:YAG Laser Cystolithotripsy

Interventions

Dusting Holmium:YAG Laser Cystolithotripsy PROCEDURE

Transurethral Holmium:YAG laser cystolithotripsy using a dusting strategy with planned laser settings of 0.5-0.8 J and 10-15 Hz, aiming to reduce the bladder stone into fine particulate debris and tiny fragments with minimal need for active fragment extraction.

Dusting

Fragmentation Holmium:YAG Laser Cystolithotripsy PROCEDURE

Transurethral Holmium:YAG laser cystolithotripsy using a fragmentation strategy with planned laser settings of 1.0 J and 6-10 Hz, aiming to produce visible extractable stone fragments of approximately 2-5 mm, with active fragment removal when needed.

Fragmentation

Eligibility Criteria

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

You may qualify if:

• Children aged less than 18 years.
• Radiologically confirmed single bladder stone less than 3 cm.
• Suitable for transurethral cystolithotripsy.
• Fit for general anesthesia.
• Written informed consent from parents or legal guardians.

You may not qualify if:

• Giant bladder stones more than 3 cm.
• Urethral pathology preventing safe transurethral access.
• Major lower urinary tract anomaly or neurogenic bladder.
• Active untreated urinary tract infection.
• Coagulation disorder or contraindication to endoscopic surgery.

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

Urinary Bladder Calculi

Condition Hierarchy (Ancestors)

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

Study Officials

• Hany F Badawy, MD

  Faculty of Medicine, Beni-Suef University hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hany F Badawy, MD

CONTACT

+201149525028; Hanyfathy86@gmail.com

Ghada S Etman, MD

CONTACT

+2010 07913852; DrhanYFATHY86@GMAIL.COM

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The operating surgeon cannot be blinded because of the nature of the laser technique. Participants and their families, as well as postoperative outcome assessors, will remain blinded to treatment allocation whenever possible.
• 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: Participants will be randomized in a 1:1 ratio to undergo transurethral Holmium:YAG laser cystolithotripsy using either a dusting strategy or a fragmentation strategy for pediatric bladder stones.

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 3, 2026
• Study Start: May 6, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)