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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07642466
Adult Bladder and Quality of Life Evaluation in Spina Bifida (ABLE-SB)
10 de junio de 2026 actualizado por: Blayne Welk
Patient Reported Outcomes for Bladder Management Strategies in Young Adults With Spina Bifida
Spina bifida (SB) is a birth defect that affects the spine, often causing paralysis in the legs and problems with bladder and bowel control.
Managing these bladder issues is important, but different methods, like using a catheter or surgery, can impact a person's quality of life.
This study looks at how different bladder management methods affect the quality of life for young people with SB.
Researchers will ask people with SB to complete a survey about how they manage their bladder and how it impacts their daily lives.
The main goal is to find out if certain bladder management methods are associated with a better quality of life.
This information could help doctors make better treatment decisions and counsel young people living with SB.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
Spina bifida is a congenital defect of the spine where some of the spinal cord and its covering (meninges) are exposed through a gap in the lower back or sacrum; this often results in paralysis of the lower limbs.
The majority of spina bifida (SB) patients also have pelvic floor dysfunction (bladder, bowel, prolapse, sexual function) because of neurologic damage to this portion of the spinal nerves, and this increases the risk of their long-term morbidity.
These problems place a substantial burden on patients' physical health and quality of life (QoL).
Serious urological complications, such as urosepsis, skin breakdown, and renal failure, can occur in this patient population due to bladder dysfunction.
Approximately 50% of young adults with SB have renal dysfunction, 50% have urinary incontinence, and they are nine times more likely to present with urinary tract infections.
The "gold standard" bladder management strategy when a person with SB is unable to void spontaneously is to perform clean intermittent catheterization (CIC).
Alternatives to CIC include spontaneous voiding (if possible), incontinence products, an indwelling catheter (IDC), or reconstructive surgery (to create a urinary diversion or to enable CIC).
However, IDC and surgery have increased risks of specific complications, including the risk of bladder cancer, urethral damage, urinary infections, and surgical morbidity.
People with SB usually discuss bladder management options with their urologist, however they may prioritize a variety of factors around bladder management that directly affect their QOL, and these may not be as apparent to urologists.
This is further complicated when patients reach adolescence and young adulthood; at this age they transition from pediatric to adult care providers, all while transitioning in other areas of their life (such as increasing responsibility, cognitive growth, and a wish for more independence).
These factors may all impact thoughts about bladder management.
Few studies have addressed QoL in relation to different bladder/bowel management methods in this SB age group, and most have not considered things like health literacy and cognitive function.
Tipo de estudio
De observación
Inscripción (Estimado)
300
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Mary McKibbon, BNSc
- Número de teléfono: 519-646-6367
- Correo electrónico: mary.mckibbon@sjhc.london.on.ca
Ubicaciones de estudio
-
-
Ontario
-
London, Ontario, Canadá
- Reclutamiento
- St Joseph's Hospital
-
Contacto:
- Mary McKibbon, BNSc
- Número de teléfono: 5196466367
- Correo electrónico: mary.mckibbon@sjhc.london.on.ca
-
Contacto:
- Brenda Hodgins
- Número de teléfono: 5196466000
- Correo electrónico: brenda.hodgins@sjhc.london.on.ca
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
To be included in the study, participants have to be adolescents (13-17 years of age) or adults (≥18 years of age) with SB and no acute health changes.
SB included all types, including SB occulta, meningocele, lipomeningocele, and myelomeningocele.
The investigators are interested in including the SB transitional age group as well, recognizing this age group represents unique and diverse psychosocial, cognitive and functional abilities.
Descripción
Inclusion Criteria:
- Diagnosis of SB
- Age ≥13 years of age
- Able to effectively communicate in English or Spanish
- Willing to provide informed consent for participation and answer a set of questionnaires
Exclusion Criteria:
- Reconstructive surgery or urinary diversion in the last 3 months
- Hospital admission in the last 1 month
- Inconsistent or newly changed (within the last month) method of bladder management
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
Voiding/incontinence
SB patients who manage their bladder with voiding/incontinence
|
|
CIC
SB patients who manage their bladder with clean intermittent catheters
|
|
Diversion
SB patients who manage their urination with a surgical bladder diversion
|
|
Indwelling catheter
SB patients who manage their bladder with an indwelling catheter
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
QUAlity of Life Assessment in Spina bifida (bladder and bowel quality of life domain)
Periodo de tiempo: At the time of enrollment
|
The QUALAS is a validated quality of life measure for teens and adults with spina bifida.
It is scored from 0-100, with a higher score meaning better QOL
|
At the time of enrollment
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Neurogenic Bladder Symptom Score-Short Form
Periodo de tiempo: At time of enrollment
|
The NBSS-SF is a validated assessment of bladder symptom burden
|
At time of enrollment
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Blayne Welk, MD MSc, Western University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de enero de 2025
Finalización primaria (Estimado)
31 de octubre de 2026
Finalización del estudio (Estimado)
1 de noviembre de 2026
Fechas de registro del estudio
Enviado por primera vez
4 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
4 de junio de 2026
Publicado por primera vez (Actual)
11 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 15140 (City of Hope Medical Center)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan IPD
The investigators will consider sharing data on a case by case basis, after the primary analysis is complete.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .