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Transurethral Versus Percutaneous Cystolithotripsy for Bladder Stones in Adults

3. september 2026 opdateret af: Mohamed Sayed Ahmed Aboliela, Assiut University

Transurethral Versus Percutaneous Cystolithotripsy for the Management of Bladder Stones in Adults: A Prospective Randomized Comparative Study

This study evaluates and compares two minimally invasive surgical approaches for treating bladder stones in adult patients: transurethral cystolithotripsy (TUCL) and percutaneous cystolithotripsy (PCCL).

Urinary bladder stones are commonly managed using endoscopic techniques to avoid the morbidity of open surgery. TUCL accesses the bladder through the natural urinary channel (urethra), whereas PCCL accesses the bladder directly through a small puncture in the lower abdomen above the pubic bone. While both approaches are effective, comparative data in adult populations remain limited.

Eligible participants are randomly assigned to receive either TUCL or PCCL. The primary goal is to compare stone clearance rates and operative times between the two procedures. Secondary objectives include comparing surgical complication rates, duration of postoperative urinary catheterization, and length of hospital stay.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Ikke anvendelig

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:

  • Adult patients aged 18 years or older
  • Diagnosed with single or multiple urinary bladder stones
  • Stone diameter between 1 and 4 cm at its largest diameter or cumulative stone diameter
  • Candidates for both transurethral and percutaneous endoscopic treatment modalities

Exclusion Criteria:

  • Active urinary tract infection (UTI)
  • Uncorrected coagulopathy or bleeding disorders
  • Known urethral stricture or significant urethral pathology precluding safe transurethral instrumentation
  • History of bladder augmentation, major lower abdominal surgery, or pelvic radiotherapy
  • Concomitant bladder tumor or suspected bladder neoplasm
  • Stone located within a bladder diverticulum or within a contracted bladder
  • Requiring concomitant urological procedures during the same operative session (e.g., transurethral resection of the prostate [TURP] or lower ureteric stone extraction)
  • Urethral stones pushed back into the bladder
  • Refusal to participate in the study

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Group A: Transurethral Cystolithotripsy (TUCL)
Participants undergo transurethral cystolithotripsy under spinal or general anesthesia. A rigid cystoscope is introduced through the urethra under direct vision. Bladder calculi are visualized and fragmented using a Mauermayer stone punch and/or pneumatic lithotripter via a semirigid ureteroscope. Stone fragments are evacuated using an Ellik evacuator and/or grasping forceps. Stone clearance and mucosal integrity are confirmed by cystoscopy, followed by insertion of a two-way urethral Foley catheter.
Procedure: Transurethral Cystolithotripsy
Under spinal or general anesthesia, a rigid cystoscope is introduced transurethrally under direct vision. Bladder calculi are visualized and fragmented using a Mauermayer stone punch and/or pneumatic lithotripter via a semirigid ureteroscope according to stone size and consistency. Stone fragments are evacuated using an Ellik evacuator and/or grasping forceps. Complete clearance and mucosal integrity are confirmed by cystoscopy, followed by insertion of a two-way urethral Foley catheter.
Aktiv komparator: Group B: Percutaneous Cystolithotripsy (PCCL)
Participants undergo percutaneous cystolithotripsy under spinal or general anesthesia. The bladder is filled retrogradely with 300-400 cc of sterile irrigation fluid via cystoscopy. Under ultrasound and cystoscopic guidance, a midline suprapubic puncture is performed with an 18G needle, followed by guidewire insertion, fascial dilation, and placement of a 30 F Amplatz sheath. Stones are fragmented with a pneumatic lithotripter via a 26 F nephroscope and extracted with grasping forceps. Postoperative drainage includes a urethral Foley catheter (with or without a suprapubic catheter).
Procedure: Percutaneous Cystolithotripsy
Under spinal or general anesthesia, the bladder is distended retrogradely with 300-400 cc sterile irrigation fluid via cystoscopy. Under combined ultrasound and cystoscopic guidance, a midline suprapubic percutaneous puncture is executed using an 18G needle, followed by guidewire placement, tract dilation, and insertion of a 30 F Amplatz working sheath. A 26 F rigid nephroscope is introduced, and calculi are fragmented using a pneumatic lithotripter and removed with grasping forceps. A urethral Foley catheter is placed postoperatively, with or without a suprapubic tube based on intraoperative findings.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Stone-Free Rate
Tidsramme: 1 day
Stone-free status is defined as complete stone clearance or presence of clinically insignificant residual fragments (CIRF) <= 2 mm confirmed by direct endoscopic inspection.
1 day

Samarbejdspartnere og efterforskere

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

Sponsor

Assiut University

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 (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

1. oktober 2028

Studieafslutning (Anslået)

1. november 2028

Datoer for studieregistrering

Først indsendt

3. september 2026

Først indsendt, der opfyldte QC-kriterier

3. september 2026

Først opslået (Faktiske)

9. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TUCL vs PCCL for Bladder Stone

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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