An Observational, Multinational, In Hospital Evaluation of Catheter Utilization Rates in Female Patients Using Indwelling Urinary Catheters and the PureWick™ Flex Female External Catheter Across Europe and the Middle East (REDUCE)
Urinary catheterization is commonly used in hospitalized patients for the management of urinary incontinence, immobilization, and monitoring of urinary output. However, indwelling urinary catheters (IUCs) are associated with clinically significant risks, including catheter-associated urinary tract infections (CAUTIs), other infectious and non-infectious complications, prolonged hospital stay, and increased healthcare costs. The risk of complications increases with the duration of catheterization, highlighting the need for strategies to reduce unnecessary catheter use and minimize catheter dwell time.
The PureWick™ Female External Catheter (FFEC) is a non-invasive urine collection device designed to manage urinary incontinence in female patients without the need for an indwelling catheter. By providing an alternative approach to urinary management, it has the potential to reduce reliance on IUCs and associated complications while improving patient comfort and quality of care.
This study is a prospective, multinational, observational, sequential two-cohort study conducted in hospitalized adult female patients across Europe and the Middle East. The study aims to evaluate the effect of introducing the PureWick™ FFEC into clinical practice on indwelling urinary catheter utilization rates in routine hospital care.
Approximately 240 adult female patients requiring urinary management for incontinence during hospitalization will be enrolled across multiple clinical sites. The study consists of two sequential cohorts within participating sites. In Cohort 1, patients will receive standard care using indwelling urinary catheters only. In Cohort 2, following the introduction of the PureWick™ FFEC, patients will be managed using either the external catheter alone or in combination with indwelling catheters, according to routine clinical practice.
The primary objective is to compare indwelling urinary catheter utilization rates before and after the introduction of the PureWick™ FFEC. Catheter utilization is defined as the proportion of inpatient days during which an indwelling catheter is used (catheter-days per patient-days).
Secondary objectives include assessment of the occurrence and nature of adverse events, including urinary tract infections, catheter-associated urinary tract infections, incontinence-associated dermatitis, and falls, as well as evaluation of hospital length of stay. Exploratory objectives include assessment of patient and healthcare professional experience, device usability and satisfaction, pain and discomfort, and sleep quality.
Participants will be followed from enrollment until hospital discharge or up to 40 days, whichever occurs first. The results of this study are intended to provide real-world evidence on urinary catheter utilization patterns and to inform clinical practice regarding the role of non-invasive urinary management strategies in hospitalized female patients.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Stephan Hofmann
- Número de teléfono: +49.160.105.3421
- Correo electrónico: Stephan.Hofmann@bd.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Hospitalized adult female patients (≥18 years) requiring urinary management for incontinence and who are unable to use standard toileting methods due to limited mobility. Participants are expected to have an inpatient stay of at least 10 days and require use of a urinary collection approach, including indwelling urinary catheters and/or a non-invasive external urinary catheter system, as part of routine clinical care.
Subjects will be enrolled from acute care hospital settings across multiple sites in Europe and the Middle East, representing a real-world inpatient population requiring urinary management.
Descripción
Inclusion Criteria:
- Adult female subjects ≥ 18 years of age at the time of signing the informed consent.
- Requiring treatment with indwelling urinary catheters or PureWick™ Flex Female External Catheter (PureWick™ FFEC) for urinary management, including urinary incontinence for at least 3 days after enrollment.
- Has limited mobility and is not able to use sanitary devices that facilitate controlled bladder emptying like bedpans, commode chairs, voiding at the toilet
- The expected length of stay from enrollment to hospital discharge is at minimum 10 days
- Willing to comply with all study procedures in this protocol
- The subject must be willing and able to read, understand, sign, and date the informed consent form.
Exclusion Criteria:
- Clinically confirmed urinary retention.
- Requiring precise urine output measurement
- Is known to be pregnant at time of enrollment
- Has a confirmed diagnosis of a urinary tract infection (UTI), catheter-associated urinary tract infection (CAUTI), or sepsis at the time of the planned indwelling urinary catheter implantation
- Has documented colonization or infection with multidrug-resistant organisms (MDROs) at the time of the planned indwelling urinary catheter implantation
- Is agitated, combative, and/or uncooperative and may remove the catheter
- Has any pre-existing neurological, psychiatric, or other conditions that would confound quality of life assessment or would make it difficult to self-report on quality-of-life questionnaires in the opinion of the investigator
Has any other condition that, in the opinion of the investigator, would preclude them from participating in the study.
Additional Exclusion Criteria (Cohort 2 only - PureWick™ FFEC):
- Has frequent episodes of bowel incontinence without a fecal management system in place
- Has moderate to heavy menstruation and cannot use a tampon or menstrual cup
- Has vaginal or other chronic non-urinary tract infections (UTIs), active genital herpes
- Has any clinically relevant skin condition (e.g. wound, lesion or irritation) affecting the genital, perineal, or sacral area that could interfere with safe and effective device use where is in contact with the device.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Standard of Care (Indwelling Urinary Catheter)
Participants managed for urinary incontinence using indwelling urinary catheters only, in accordance with routine clinical practice.
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An internal urinary catheter inserted into the bladder to allow continuous drainage of urine, used as part of standard of care in hospitalized patients.
Type and model may vary according to institutional practice.
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PureWick™ Flex Female External Catheter (FFEC) Implementation
Participants managed for urinary incontinence following the introduction of the PureWick™ Female External Catheter, using either the external catheter alone or in combination with indwelling urinary catheters, in accordance with routine clinical practice.
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An internal urinary catheter inserted into the bladder to allow continuous drainage of urine, used as part of standard of care in hospitalized patients.
Type and model may vary according to institutional practice.
A non-invasive external urine collection device used for management of urinary incontinence in hospitalized female patients.
The device is applied externally and connected to low-pressure suction for urine collection.
It is used according to routine clinical practice, either as first-line management or following use of an indwelling urinary catheter.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Indwelling Urinary Catheter (IUC) Utilization Rate
Periodo de tiempo: From enrollment (informed consent) until hospital discharge or up to 40 days, whichever occurs first
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The proportion of inpatient days during which an indwelling urinary catheter is used, defined as the number of catheter-days divided by the total number of patient-days.
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From enrollment (informed consent) until hospital discharge or up to 40 days, whichever occurs first
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Occurrence of Adverse Events (AEs)
Periodo de tiempo: From enrollment until hospital discharge or up to 40 days
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Incidence and nature of adverse events, including all adverse events, device- and/or procedure-related events, and serious adverse events.
Events of interest include catheter-associated urinary tract infections (CAUTI), urinary tract infections (UTI), incontinence-associated dermatitis (IAD), and falls.
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From enrollment until hospital discharge or up to 40 days
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Length of Hospital Stay (LOS)
Periodo de tiempo: From enrollment until discharge or up to 40 days
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Number of days from study enrollment (informed consent) to hospital discharge or end of study.
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From enrollment until discharge or up to 40 days
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Patient and Healthcare Professional (HCP) Assessment of Device Use
Periodo de tiempo: Patient assessments are collected at baseline, every 7 days during device use, and at device removal/discharge. HCP assessments are collected at device removal, hospital discharge, or Day 40/end of study.
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Assessment of usability, comfort, satisfaction, and preference for urinary management methods, collected using structured questionnaires at the end of the treatment period.
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Patient assessments are collected at baseline, every 7 days during device use, and at device removal/discharge. HCP assessments are collected at device removal, hospital discharge, or Day 40/end of study.
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Pain Associated with Urinary Management
Periodo de tiempo: Baseline through discharge or Day 40.
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Patient-reported pain assessed using standardized scales, including Numeric Pain Rating Scale (NRS).
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Baseline through discharge or Day 40.
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Sleep Disturbance
Periodo de tiempo: Assessed at baseline, Day 7, Day 14, Day 28, and at hospital discharge or Day 40, whichever occurs first.
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Patient-reported sleep disturbance assessed using the PROMIS Sleep Disturbance questionnaire.
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Assessed at baseline, Day 7, Day 14, Day 28, and at hospital discharge or Day 40, whichever occurs first.
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Discomfort Associated with Urinary Management
Periodo de tiempo: Assessed at baseline, every 7 days (±1 day) during device use, and at device removal, hospital discharge, or Day 40, whichever occurs first.
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Patient-reported discomfort associated with urinary management, including Catheter-Related Bladder Discomfort (CRBD), assessed using study-specific questionnaires and standardized assessment tools.
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Assessed at baseline, every 7 days (±1 day) during device use, and at device removal, hospital discharge, or Day 40, whichever occurs first.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
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Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades urogenitales masculinas
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Trastornos de la micción
- Síntomas del tracto urinario inferior
- Manifestaciones Urológicas
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Incontinencia urinaria
Otros números de identificación del estudio
- UCC-25AC025
Plan de datos de participantes individuales (IPD)
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Descripción del plan 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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