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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)

29 juni 2026 uppdaterad av: 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.

Studieöversikt

Studietyp

Observationell

Inskrivning (Beräknad)

80

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Residual stone size greater than 4mm postoperatively.
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Qol-DUCC questionnaire answers
Tidsram: At inclusion
answers to the Qol-DUCC questionnaire will be analysed to assess patient quality of life
At inclusion
Qualiveen questionnaire score
Tidsram: At inclusion

The Qualiveen questionnaire score will be analysed to assess patient quality of life, for individuals who have urinary disorders.

It contains 4 domains: Limitations/Inconvenience, Constraints/Restrictions, Fears, Feelings/Impact on Daily Life. The questionnaire is based on a 5-point Likert scale (0 = "not at all", 4 = "extremely"). Each domain score is calculated as an average of the scores for the domain items. An overall (averaged) score can also be calculated. Lower scores on this questionnaire indicate higher quality of life.

At inclusion

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Nadia ABID, MD, PhD, Hospices Civils de Lyon

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

1 januari 2027

Avslutad studie (Beräknad)

1 januari 2027

Studieregistreringsdatum

Först inskickad

8 juni 2026

Först inskickad som uppfyllde QC-kriterierna

8 juni 2026

Första postat (Faktisk)

11 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

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NEJ

Läkemedels- och apparatinformation, studiedokument

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Nej

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