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.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Nadia ABID, MD, PhD
- Número de teléfono: +33 4 72 11 96 75
- Correo electrónico: nadia.abid@chu-lyon.fr
Copia de seguridad de contactos de estudio
- Nombre: Léonard TOTARO, MD
- Número de teléfono: +33 613230009
- Correo electrónico: leonard.totaro@chu-lyon.fr
Ubicaciones de estudio
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Lyon, Francia, 69003
- Hôpital Edouard Herriot
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Contacto:
- Nadia ABID, MD, PhD
- Número de teléfono: +33 4 72 11 96 75
- Correo electrónico: nadia.abid@chu-lyon.fr
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Pierre-Bénite, Francia, 69495
- Hopital Lyon Sud
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Contacto:
- Théo ARBER, MD, PhD
- Número de teléfono: +33 472678813
- Correo electrónico: theo.arber@chu-lyon.fr
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Número de grupos/cohortes
Cohortes e Intervenciones
Grupo / CohorteGrupo / Cohorte |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Trans-Stomal Bladder Lithotripsy Using Mini-Percutaneous Equipment
Patient operated on using Trans-Stomal Bladder Lithotripsy Using Mini-Percutaneous Equipment
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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
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Trans-stomial bladder lithotripsy using flexible fibroscope
Patient operated on using Trans-stomial bladder lithotripsy using flexible fibroscope
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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
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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
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Open Cystolithotomy
Patient operated on using Open Cystolithotomy
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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
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Residual stone size greater than 4mm postoperatively.
Periodo de tiempo: Up to 7 days after surgery
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Residual stone size greater than 4mm postoperatively will be investigated on imaging control
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Up to 7 days after surgery
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Qol-DUCC questionnaire answers
Periodo de tiempo: At inclusion
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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
Periodo de tiempo: At inclusion
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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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Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Nadia ABID, MD, PhD, Hospices Civils de Lyon
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades urogenitales masculinas
- Cálculos
- Condiciones Patológicas, Anatómicas
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Urolitiasis
- Cálculos urinarios
- Enfermedades de la vejiga urinaria
- Condiciones Patológicas, Signos y Síntomas
- Cálculos de la vejiga urinaria
Otros números de identificación del estudio
Otros números de identificación del estudio
- 69HCL26_0256
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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