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NCT Number: NCT07623980

Dusting vs Fragmentation Laser Cystolithotripsy for Pediatric Bladder Stones

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.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Urology- Beni-Suef University Hospitals

Banī Suwayf, Beni Suweif Governorate, Egypt

Location status: Recruiting

Location contact

Hany F Badawy, MD

CONTACT

[email protected]

+201149525028

About this study

This is a prospective randomized controlled trial conducted at the Department of Urology, Faculty of Medicine, Beni-Suef University Hospital.

The study will include children with radiologically confirmed single bladder stones less than 3 cm who are planned for transurethral Holmium:YAG laser cystolithotripsy and are suitable for transurethral endoscopic management under general anesthesia. Written informed consent will be obtained from parents or legal guardians before enrollment.

Eligible children will be randomized in a 1:1 ratio into two groups. Participants in the dusting group will undergo transurethral Holmium:YAG laser cystolithotripsy using low pulse energy and higher pulse frequency settings, with the aim of reducing the stone into fine particulate debris and tiny fragments with minimal need for active extraction. Participants in the fragmentation group will undergo transurethral Holmium:YAG laser cystolithotripsy using higher pulse energy and lower pulse frequency settings, with the aim of producing visible extractable fragments that can be actively removed when needed.

All procedures will be performed under general anesthesia in the lithotomy position using a pediatric semi-rigid ureteroscope. A Holmium:YAG laser will be used in both groups. The planned settings are 0.5-0.8 J and 10-15 Hz in the dusting group, and 1.0 J and 6-10 Hz in the fragmentation group. A 550-micron end-firing laser fiber will be preferred when compatible with the available endoscope.

The primary outcome is total operative time, defined as the time in minutes from insertion of the endoscope into the urethra until completion of stone clearance and termination of the procedure, including fragment retrieval when required. 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 at follow-up, intraoperative mucosal injury or bleeding, need for postoperative catheterization, postoperative hematuria, dysuria, urinary tract infection, and hospital stay. Follow-up will be scheduled at 1 week, 1 month, and 3 months with clinical assessment and ultrasonography.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Total Operative Time

    Time frame: During the index transurethral cystolithotripsy procedure

    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.

Secondary outcomes

  1. Laser Time

    Time frame: During the index transurethral cystolithotripsy procedure

    Laser time will be measured in minutes as the cumulative duration of active Holmium:YAG laser firing during the index transurethral cystolithotripsy procedure.

  2. Need for Active Fragment Extraction

    Time frame: During the index transurethral cystolithotripsy procedure

    The need for active fragment extraction will be recorded as whether stone fragments required active removal using endoscopic retrieval maneuvers during the index transurethral cystolithotripsy

    procedure.

  3. Endoscopic Stone-Free Status at the End of the Procedure

    Time frame: At the end of the index transurethral cystolithotripsy proced

    Endoscopic stone-free status will be assessed at the end of the procedure and defined as no visible residual bladder stone fragments on final endoscopic inspection.

  4. Postoperative Hematuria

    Time frame: From the end of the procedure to 1 month postoperatively

    Postoperative hematuria will be recorded based on clinical observation or patient/guardian report during postoperativ follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Ghada S Etman, MD

CONTACT

[email protected]

+2010 07913852

Hany F Badawy, MD

CONTACT

[email protected]

+201149525028

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

Dusting Versus Fragmentation With Holmium:YAG Laser During Transurethral Cystolithotripsy in Pediatric Bladder Stones: A Prospective Randomized Trial

Acronym: DUST-FRAG-PED

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 3, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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