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

8. juni 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

140

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Egypten
    • Beni Suweif Governorate
      • Banī Suwayf, Beni Suweif Governorate, Egypten
        • Rekruttering
        • Department of Urology- Beni-Suef University Hospitals
        • Ledende efterforsker:
          • Hany F Badawy, MD
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Procedure: 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.
Eksperimentel: 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
Procedure: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total Operative Time
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Stone Fragmentation and Clearance Time
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Beni-Suef University

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

8. juni 2026

Primær færdiggørelse (Anslået)

1. maj 2028

Studieafslutning (Anslået)

1. juni 2028

Datoer for studieregistrering

Først indsendt

8. juni 2026

Først indsendt, der opfyldte QC-kriterier

8. juni 2026

Først opslået (Faktiske)

11. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FMBSUREC-07062026a-Badawy

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Standard Transurethral Holmium Laser Cystolithotripsy

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