A Comparison of Two Urinary Catheters of Different Lengths for Female Use, in Intermittent Catheterization
A Multi Centre, Single-blind, Randomized, Cross-over Study Comparing Two Female Catheters With Different Length in Terms of Residual Urine After Intermittent Catheterization
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The study personnel will conduct three bladder scans after each catheterization in order to obtain the mean residual urine volume. Each patient will catheterize herself two times with each product, i.e. a total of four catheterizations.
Diagnosis and BMI will be collected at visit 1 to assess whether the residual urine volume differs between these subgroups.
The hypothesis that the mean residual volumes were equal when using the 7 and the 10 centimeter catheters was tested by means of the Wilcoxon signed rank test.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Borås, Suecia, SE-501 82
- Rehabiliteringskliniken, Södra Älvsborgs Sjukhus
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Gothenburg, Suecia, SE-413 45
- Verksamhet Urologi, Sahlgrenska Universitetssjukhuset
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Lund, Suecia, SE-221 85
- Clinical Research and Trial Centre, Lund University Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Provision of signed informed consent
- Female subjects aged 18 years and over
- Experienced users of CIC with a minimum of one month of use
- Practice CIC a minimum of 1 time per day
- Practice CIC with female catheters with a maximum length of 20 cm
- Perform self-catheterization
- Sufficient hand function to be able to open and handle catheter packages
- Use catheters with Ch 10, 12 or 14
Exclusion Criteria:
- Pregnancy
- Ongoing symptomatic UTI
- Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site)
- Previous enrolment or randomisation of treatment in the present study
- Participation in another clinical study during the study period
- Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: AABB
A=Coloplast SpeediCath Compact catheter, 7 cm B=Astra Tech POBE catheter, 10 cm 7 cm then 7 cm then 10 cm then 10 cm Four catheterizations in total, two catheterizations with each study product in a randomized order. |
Catheterization should resemble the daily use as far as possible and at least 2 hours had to pass between 2 catheterizations.The study centre decided whether the subject performed all four catheterizations on one or several days.
Otros nombres:
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Experimental: ABAB
A=Coloplast SpeediCath Compact catheter, 7 cm B=Astra Tech POBE catheter, 10 cm 7 cm then 10 cm then 7 cm then 10 cm Four catheterizations in total, two catheterizations with each study product in a randomized order. |
Catheterization should resemble the daily use as far as possible and at least 2 hours had to pass between 2 catheterizations.The study centre decided whether the subject performed all four catheterizations on one or several days.
Otros nombres:
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Experimental: ABBA
A=Coloplast SpeediCath Compact catheter, 7 cm B=Astra Tech POBE catheter, 10 cm 7 cm then 10 cm then 10 cm then 7 cm Four catheterizations in total, two catheterizations with each study product in a randomized order. |
Catheterization should resemble the daily use as far as possible and at least 2 hours had to pass between 2 catheterizations.The study centre decided whether the subject performed all four catheterizations on one or several days.
Otros nombres:
|
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Experimental: BAAB
A=Coloplast SpeediCath Compact catheter, 7 cm B=Astra Tech POBE catheter, 10 cm 10 cm then 7 cm then 7 cm then 10 cm Four catheterizations in total, two catheterizations with each study product in a randomized order. |
Catheterization should resemble the daily use as far as possible and at least 2 hours had to pass between 2 catheterizations.The study centre decided whether the subject performed all four catheterizations on one or several days.
Otros nombres:
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Experimental: BABA
A=Coloplast SpeediCath Compact catheter, 7 cm B=Astra Tech POBE catheter, 10 cm 10 cm then then 7 cm then 10 cm then 7 cm Four catheterizations in total, two catheterizations with each study product in a randomized order. |
Catheterization should resemble the daily use as far as possible and at least 2 hours had to pass between 2 catheterizations.The study centre decided whether the subject performed all four catheterizations on one or several days.
Otros nombres:
|
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Experimental: BBAA
A=Coloplast SpeediCath Compact catheter, 7 cm B=Astra Tech POBE catheter, 10 cm 10 cm then 10 cm then 7 cm then 7 cm Four catheterizations in total, two catheterizations with each study product in a randomized order. |
Catheterization should resemble the daily use as far as possible and at least 2 hours had to pass between 2 catheterizations.The study centre decided whether the subject performed all four catheterizations on one or several days.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Bladder Scan Measurements of Residual Urine Volume
Periodo de tiempo: Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. A maximum of 5 minutes were allowed to elapse between catheterization and bladder scan.
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Measurements were performed with the bladder scan BVI 3000. The primary outcome variable was average residual urine volume (mL) calculated from repetitive bladder scans performed after each catheterization. Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. |
Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. A maximum of 5 minutes were allowed to elapse between catheterization and bladder scan.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Subjects With a Residual Volume >5mL or ≤5mL
Periodo de tiempo: Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. At least 2 hours had to pass between 2 catheterizations.
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Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. At least 2 hours had to pass between 2 catheterizations.
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Number of Subjects With a Residual Volume >10mL or ≤10mL
Periodo de tiempo: Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. A maximum of 5 minutes were allowed to elapse between catheterization and bladder scan.
|
Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. A maximum of 5 minutes were allowed to elapse between catheterization and bladder scan.
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Number of Subjects With a Residual Volume >30mL or ≤30mL
Periodo de tiempo: Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. A maximum of 5 minutes were allowed to elapse between catheterization and bladder scan.
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Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. A maximum of 5 minutes were allowed to elapse between catheterization and bladder scan.
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Number of Subjects With a Residual Volume >50mL or ≤50mL
Periodo de tiempo: Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. A maximum of 5 minutes were allowed to elapse between catheterization and bladder scan.
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Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. A maximum of 5 minutes were allowed to elapse between catheterization and bladder scan.
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Does the Subject's Bladder Feel Completely Empty After Catheterisation (All Subjects)
Periodo de tiempo: Question asked minutes after catheterization.
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After each catheterization the study nurse will ask the subject whether it feels as if the bladder is completely emptied or not. 0=No and 1=Yes. |
Question asked minutes after catheterization.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ulf Malmqvist, MD, PhD, Assoc.Prof., Clinical Research and Trial Centre, Lund University Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- YA-LOF-0015
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.
producto fabricado y exportado desde los EE. UU.
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