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.
調査の概要
状態
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Stephan Hofmann
- 電話番号：+49.160.105.3421
- メール：Stephan.Hofmann@bd.com
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
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.
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Indwelling Urinary Catheter (IUC) Utilization Rate
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Occurrence of Adverse Events (AEs)
時間枠：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)
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient and Healthcare Professional (HCP) Assessment of Device Use
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- UCC-25AC025
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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