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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)
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Nadia ABID, MD, PhD
- Telefoonnummer: +33 4 72 11 96 75
- E-mail: nadia.abid@chu-lyon.fr
Studie Contact Back-up
- Naam: Léonard TOTARO, MD
- Telefoonnummer: +33 613230009
- E-mail: leonard.totaro@chu-lyon.fr
Studie Locaties
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Lyon, Frankrijk, 69003
- Hôpital Edouard Herriot
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Contact:
- Nadia ABID, MD, PhD
- Telefoonnummer: +33 4 72 11 96 75
- E-mail: nadia.abid@chu-lyon.fr
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Pierre-Bénite, Frankrijk, 69495
- Hopital Lyon Sud
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Contact:
- Théo ARBER, MD, PhD
- Telefoonnummer: +33 472678813
- E-mail: theo.arber@chu-lyon.fr
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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
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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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Residual stone size greater than 4mm postoperatively.
Tijdsspanne: Up to 7 days after surgery
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Residual stone size greater than 4mm postoperatively will be investigated on imaging control
|
Up to 7 days after surgery
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Qol-DUCC questionnaire answers
Tijdsspanne: At inclusion
|
answers to the Qol-DUCC questionnaire will be analysed to assess patient quality of life
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At inclusion
|
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Qualiveen questionnaire score
Tijdsspanne: 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
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Nadia ABID, MD, PhD, Hospices Civils de Lyon
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Urogenitale ziekten
- Mannelijke urogenitale ziekten
- Berekeningen
- Pathologische aandoeningen, anatomisch
- Urologische ziekten
- Vrouwelijke urogenitale ziekten
- Vrouwelijke urogenitale ziekten en zwangerschapscomplicaties
- Urolithiase
- Urinewegen
- Ziekten van de urineblaas
- Pathologische aandoeningen, tekenen en symptomen
- Urineblaas Calculi
Andere studie-ID-nummers
- 69HCL26_0256
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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