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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Stephan Hofmann
- Numéro de téléphone: +49.160.105.3421
- E-mail: Stephan.Hofmann@bd.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
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.
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Standard of Care (Indwelling Urinary Catheter)
Participants managed for urinary incontinence using indwelling urinary catheters only, in accordance with routine clinical practice.
|
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.
|
|
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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Indwelling Urinary Catheter (IUC) Utilization Rate
Délai: From enrollment (informed consent) until hospital discharge or up to 40 days, whichever occurs first
|
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.
|
From enrollment (informed consent) until hospital discharge or up to 40 days, whichever occurs first
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Occurrence of Adverse Events (AEs)
Délai: From enrollment until hospital discharge or up to 40 days
|
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.
|
From enrollment until hospital discharge or up to 40 days
|
|
Length of Hospital Stay (LOS)
Délai: From enrollment until discharge or up to 40 days
|
Number of days from study enrollment (informed consent) to hospital discharge or end of study.
|
From enrollment until discharge or up to 40 days
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Patient and Healthcare Professional (HCP) Assessment of Device Use
Délai: 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.
|
Assessment of usability, comfort, satisfaction, and preference for urinary management methods, collected using structured questionnaires at the end of the treatment period.
|
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.
|
|
Pain Associated with Urinary Management
Délai: Baseline through discharge or Day 40.
|
Patient-reported pain assessed using standardized scales, including Numeric Pain Rating Scale (NRS).
|
Baseline through discharge or Day 40.
|
|
Sleep Disturbance
Délai: Assessed at baseline, Day 7, Day 14, Day 28, and at hospital discharge or Day 40, whichever occurs first.
|
Patient-reported sleep disturbance assessed using the PROMIS Sleep Disturbance questionnaire.
|
Assessed at baseline, Day 7, Day 14, Day 28, and at hospital discharge or Day 40, whichever occurs first.
|
|
Discomfort Associated with Urinary Management
Délai: Assessed at baseline, every 7 days (±1 day) during device use, and at device removal, hospital discharge, or Day 40, whichever occurs first.
|
Patient-reported discomfort associated with urinary management, including Catheter-Related Bladder Discomfort (CRBD), assessed using study-specific questionnaires and standardized assessment tools.
|
Assessed at baseline, every 7 days (±1 day) during device use, and at device removal, hospital discharge, or Day 40, whichever occurs first.
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies urogénitales masculines
- Maladies urologiques
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Troubles urinaires
- Symptômes des voies urinaires inférieures
- Manifestations urologiques
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Incontinence urinaire
Autres numéros d'identification d'étude
- UCC-25AC025
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
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