Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Dusting vs Fragmentation Laser Cystolithotripsy for Pediatric Bladder Stones (DUST-FRAG-PED)

28 mei 2026 bijgewerkt door: Hany Fathy Badawy, MD, Beni-Suef University

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

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

110

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Egypte
    • Beni Suweif Governorate
      • Banī Suwayf, Beni Suweif Governorate, Egypte
        • Werving
        • Department of Urology- Beni-Suef University Hospitals
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

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

Exclusion Criteria:

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Dusting
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
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.
Actieve vergelijker: Fragmentation
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
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Total Operative Time
Tijdsspanne: 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.
During the index transurethral cystolithotripsy procedure

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Laser Time
Tijdsspanne: 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.
During the index transurethral cystolithotripsy procedure
Need for Active Fragment Extraction
Tijdsspanne: 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.
During the index transurethral cystolithotripsy procedure
Endoscopic Stone-Free Status at the End of the Procedure
Tijdsspanne: 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.
At the end of the index transurethral cystolithotripsy proced
Postoperative Hematuria
Tijdsspanne: 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.
From the end of the procedure to 1 month postoperatively

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Beni-Suef University

Onderzoekers

  • Hoofdonderzoeker: Hany F Badawy, MD, Faculty of Medicine, Beni-Suef University hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

6 mei 2026

Primaire voltooiing (Geschat)

1 april 2027

Studie voltooiing (Geschat)

1 mei 2027

Studieregistratiedata

Eerst ingediend

28 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 mei 2026

Eerst geplaatst (Werkelijk)

3 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

28 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • FMBSUREC05052026BadawyDF
  • FMBSUREC/05052026/Badawy (Andere identificatie: FM-BSU REC)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual participant data will not be shared. Only aggregated, de-identified study results will be reported. Individual-level pediatric clinical data will remain confidential and will be accessible only to the study investigators and authorized regulatory or ethics committee representatives if required.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren