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Brief Title Suprapubic Drainage During Transurethral Cystolithotripsy for Large Bladder Stones (SPT-CYSTO Tria)

8 giugno 2026 aggiornato da: Hany Fathy Badawy, MD, Beni-Suef University

Transurethral Cystolithotripsy With Versus Without Adjunctive Suprapubic Tube Drainage for Bladder Stones >2 cm: A Prospective Randomized Controlled Trial

Bladder stones larger than 2 cm are commonly treated by endoscopic fragmentation through the urethra. During transurethral cystolithotripsy for large stones, the procedure may be prolonged because of poor visibility, stone dust, bladder overdistension, and repeated need for irrigation or evacuation.

This randomized controlled trial will compare standal Holmium:YAG laser cystolithotripsy using a 17 Fr cystoscope sheath with the same procedure plus an adjunctive 8 Fr suprapubic catheter used only for bladder drainage during the operation. The suprapubic catheter will not be used for stone fragmentation or stone extraction.

The main outcome will be total operative time. Secondary outcomes will include fragmentation and clearance time, laser activation time, total laser energy, irrigation volume, visibility-related interruptions, stone-free rate at 30 days, complications, catheter duration, postoperative pain, and hospital stay.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This is a prospective, randomized, controlled, parallel-group clinical trial conducted at the Department of Urology, Beni-Suef University Hospital, Faculty of Medicine, Beni-Suef University, Egypt. Adult patients with radiologically confirmed bladder stones greater than 2 cm who are scheduled for elective transurethral cystolithotripsy will be enrolled after written informed consent.

Participants will be randomized in a 1:1 ratio into two groups. The control group will undergo standardized transurethral Holmium:YAG laser cystolithotripsy using a 17 Fr cystoscope sheath with conventional irrigation and transurethral evacuation only. The experimental group will undergo the same procedure with adjunctive 8 Fr suprapubic catheter drainage inserted under ultrasound guidance and cystoscopic visualization. The suprapubic catheter will be connected to free drainage during lithotripsy to assist bladder decompression and irrigation outflow. It will not be used for stone fragmentation, stone extraction, tract dilation, sheath placement, or percutaneous cystolithotripsy.

All procedures will use the same standardized cystoscopic access, Holmium:YAG laser platform, irrigation system, and transurethral evacuation method. The primary outcome is total operative time, measured from cystoscope insertion into the urethra until endoscopic confirmation of complete stone clearance and completion of final urethral catheter placement. Postoperative follow-up will continue for 30 days, including assessment of stone-free status by imaging and recording of perioperative complications.

Tipo di studio

Interventistico

Iscrizione (Stimato)

140

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Egitto
    • Beni Suweif Governorate
      • Banī Suwayf, Beni Suweif Governorate, Egitto
        • Reclutamento
        • Department of Urology- Beni-Suef University Hospitals
        • Investigatore principale:
          • Hany F Badawy, MD
        • Contatto:
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Age 18 years or older.
  • Radiologically confirmed bladder stone with maximum diameter greater than 2 cm.
  • Scheduled for elective transurethral cystolithotripsy.
  • Sterile urine culture before surgery, or adequately treated urinary tract infection according to culture sensitivity.
  • Fit for spinal or general anesthesia.
  • Ability to provide written informed consent.

Exclusion Criteria:

  • Urethral stricture preventing safe cystoscopic access.
  • Active uncontrolled urinary tract infection or sepsis.
  • Neurogenic bladder with severely impaired bladder emptying requiring chronic catheterization.
  • History of bladder cancer or suspected bladder tumor requiring simultaneous transurethral resection of bladder tumor.
  • Coagulopathy or uncorrected bleeding tendency.
  • Patients requiring concomitant transurethral resection of the prostate, Holmium laser enucleation of the prostate, or other prostate surgery in the same session.
  • Previous pelvic radiotherapy or major lower urinary tract reconstruction.
  • Pregnancy.
  • Refusal to participate.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Standard Transurethral Cystolithotripsy
Participants assigned to this arm will undergo standardized transurethral Holmium:YAG laser cystolithotripsy using a 17 Fr cystoscope sheath with conventional irrigation and transurethral evacuation only, without adjunctive suprapubic catheter drainage.
Procedura: Standard Transurethral Holmium Laser Cystolithotripsy
Standardized transurethral Holmium:YAG laser cystolithotripsy performed through a 17 Fr cystoscope sheath, with conventional irrigation and transurethral evacuation of stone dust and fragments. A urethral Foley catheter will be inserted at the end of the procedure. This procedure will be performed in both study arms.
Sperimentale: Transurethral Cystolithotripsy With Suprapubic Drainage
Participants assigned to this arm will undergo the same standardized transurethral Holmium:YAG laser cystolithotripsy using a 17 Fr cystoscope sheath, with adjunctive 8 Fr suprapubic catheter drainage inserted under ultrasound guidance and cystoscopic visualization for bladder drainage and decompression during lithotripsy. No stone fragmentation or extraction will be performed through the suprapubic route
Procedura: Adjunctive Suprapubic Catheter Drainage
Insertion of an 8 Fr suprapubic catheter under ultrasound guidance and cystoscopic visualization during transurethral cystolithotripsy. The catheter will be connected to free drainage to assist bladder decompression and irrigation outflow during lithotripsy. It will not be used for stone fragmentation, stone extraction, tract dilation, sheath placement, or percutaneous cystolithotripsy.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Total Operative Time
Lasso di tempo: During the surgical procedure
Total operative time will be measured in minutes from insertion of the cystoscope into the urethra until endoscopic confirmation of complete bladder stone clearance and completion of final urethral catheter placement. In the suprapubic drainage group, the time required for insertion of the 8 Fr suprapubic catheter will be included because the study evaluates the overall procedural efficiency of adding adjunctive suprapubic cathe+ drainage
During the surgical procedure

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Stone Fragmentation and Clearance Time
Lasso di tempo: During the surgical procedure
Time measured in minutes from the start of Holmium:YAG laser lithotripsy until endoscopic confirmation of complete bladder stone fragmentation and clearance
During the surgical procedure
Total Laser Energy
Lasso di tempo: During the surgical procedure
Total Holmium:YAG laser energy delivered during cystolithotripsy, recorded in joules from the laser device.
During the surgical procedure
Visibility-Related Interruptions
Lasso di tempo: During the surgical procedure
Number of intraoperative interruptions of lithotripsy due to poor endoscopic vision, stone dust, bladder overdistension, clot, or need for evacuation or irrigation adjustment.
During the surgical procedure
Urethral Catheter Duration
Lasso di tempo: From end of surgery until catheter removal, up to 30 days
Duration of postoperative urethral Foley catheterization, measured from the end of surgery until catheter removal.
From end of surgery until catheter removal, up to 30 days
Postoperative Pain Score
Lasso di tempo: 6 hours and 24 hours after surgery
Postoperative pain will be assessed using the Visual Analogue Scale. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain.
6 hours and 24 hours after surgery

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Beni-Suef University

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

8 giugno 2026

Completamento primario (Stimato)

1 maggio 2028

Completamento dello studio (Stimato)

1 giugno 2028

Date di iscrizione allo studio

Primo inviato

8 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 giugno 2026

Primo Inserito (Effettivo)

11 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • FMBSUREC-07062026a-Badawy

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be shared because the study contains individual-level clinical and operative data. Only aggregated, de-identified study results will be reported in publications or presentations. Any future sharing of de-identified participant-level data would require additional approval from the Research Ethics Committee, Faculty of Medicine, Beni-Suef University.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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