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Comparison of Trans-Stomial Bladder Lithotripsy Using Mini-Percutaneous Equipment Versus Trans-stomial Bladder Lithotripsy Using Flexible Fibroscope, Percutaneous Approach and Open Cystolithotomy in Patients With Continent Catheterizable Urinary Reservoir (Mini-DUCC)

8. juni 2026 opdateret af: Hospices Civils de Lyon

The urological management of neurological patients is crucial to ensure patient survival and improve their quality of life. The natural progression of disease in central neurological bladders typically involves a major decrease in both bladder capacity and contractile function, often necessitating cystectomy. One alternative to urinary reconstruction is continent catheterizable urinary diversion (e.g., Miami pouch, Mitrofanoff, Monti, etc.). A common complication of these diversions is the formation of intravesical stones, which require surgical management. When the urethra allows access to the urinary diversion, the gold standard is transurethral lithotripsy using a cystoscope; however, when this is not feasible, several techniques exist, albeit without clear recommendations.

In the literature, the most frequently discussed techniques include bladder dilation, percutaneous bladder lithotripsy using nephrolithotripsy (NLPC) equipment, and trans-stomal lithotripsy using a flexible fibroscope. Although bladder dilation has shown higher complication rates in case series compared to other techniques, there is very little comparative data between the percutaneous and trans-stomal methods in the literature. Case series indicate a higher risk of fistula formation with the percutaneous technique for urinary diversions performed in the gastrointestinal tract as compared to native bladder diversions, and a risk of stenosis or loss of continence with the trans-stomal technique.

At the Hospices Civils de Lyon (HCL), the Urology Department of the Lyon Sud Hospital has expertise in neuro-urology with a large cohort of patients presenting continent catheterizable urinary diversions, and the Urology Department of Edouard Herriot Hopspital has expertise in NLPC, particularly with the use of mini-NLPC (smaller nephroscope diameter). The synergy between these two departments has enabled the creation of a large cohort, with frequent use of the percutaneous route for bladder lithotripsy and, since 2020, the trans-stomal route using mini-NLPC equipment.

Therefore, given the limited data available in the literature, this retrospective comparative study would provide stronger evidence to improve the management of these patients.

Studieoversigt

Undersøgelsestype

Observationel

Tilmelding (Anslået)

80

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

      • Lyon, Frankrig, 69003
        • Hôpital Edouard Herriot
        • Kontakt:
      • Pierre-Bénite, Frankrig, 69495

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

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Major patients with a continent cutaneous urinary diversion, followed in the urology departments of Lyon Sud Hospital and Édouard Herriot Hospital

Beskrivelse

Inclusion Criteria:

  • Adult patient (aged 18 years or older)
  • Patient with a catheterizable continent urinary diversion
  • History of surgical intervention via vesicolithotomy, percutaneous cystolitholapaxy, trans-stomal cystolitholapaxy, or flexible endoscopic laser cystolithotripsy via the continent stoma between 01/01/2015 and 31/12/2024
  • Patient has expressed non-opposition to participate in the research

Exclusion Criteria:

  • Percutaneous or trans-stomal surgery for foreign body removal
  • Postoperative follow-up period of less than 1 month after lithotripsy (Except for Clavien-Dindo Grade V cases)

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Trans-Stomal Bladder Lithotripsy Using Mini-Percutaneous Equipment
Patient operated on using Trans-Stomal Bladder Lithotripsy Using Mini-Percutaneous Equipment
Patients of all groups will answer this quality of life questionnaire that has been specially designed for the study
Patients of all groups will answer this validated quality of life questionnaire
Trans-stomial bladder lithotripsy using flexible fibroscope
Patient operated on using Trans-stomial bladder lithotripsy using flexible fibroscope
Patients of all groups will answer this quality of life questionnaire that has been specially designed for the study
Patients of all groups will answer this validated quality of life questionnaire
Percutaneous cystholithotripsy
Patient operated on using Percutaneous cystholithotripsy
Patients of all groups will answer this quality of life questionnaire that has been specially designed for the study
Patients of all groups will answer this validated quality of life questionnaire
Open Cystolithotomy
Patient operated on using Open Cystolithotomy
Patients of all groups will answer this quality of life questionnaire that has been specially designed for the study
Patients of all groups will answer this validated quality of life questionnaire

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Residual stone size greater than 4mm postoperatively.
Tidsramme: Up to 7 days after surgery
Residual stone size greater than 4mm postoperatively will be investigated on imaging control
Up to 7 days after surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Qol-DUCC questionnaire answers
Tidsramme: At inclusion
answers to the Qol-DUCC questionnaire will be analysed to assess patient quality of life
At inclusion
Qualiveen questionnaire score
Tidsramme: At inclusion
The Qualiveen questionnaire score will be analysed to assess patient quality of life
At inclusion

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Nadia ABID, MD, PhD, Hospices Civils de Lyon

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. september 2026

Primær færdiggørelse (Anslået)

1. januar 2027

Studieafslutning (Anslået)

1. januar 2027

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

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INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Bladder Calculi

Kliniske forsøg med QoL-DUCC questionnaire

Abonner