Urinary IncontinenceREDUCENCT07798128
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
An observational study of Urinary Incontinence and Limited Mobility, run by Becton, Dickinson and Company.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Limited Mobility
- What is being tested?
- PureWick™ Flex Female External Catheter (FFEC) and Indwelling Urinary Catheter (IUC)
- Type of treatment
- Medical device
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 6 Nov 2026to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
- Conditions
- Urinary Incontinence, Limited Mobility
- Being tested
- PureWick™ Flex Female External Catheter (FFEC), Indwelling Urinary Catheter (IUC)
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PureWick™ Flex Female External Catheter (FFEC)Device
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.
Indwelling Urinary Catheter (IUC)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (Indwelling Urinary Catheter) | Participants managed for urinary incontinence using indwelling urinary catheters only, in accordance with routine clinical practice. Receives: Device: Indwelling Urinary Catheter (IUC) | |
| 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. Receives: Device: PureWick™ Flex Female External Catheter (FFEC); Device: Indwelling Urinary Catheter (IUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indwelling Urinary Catheter (IUC) Utilization Rate
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.
Measured: From enrollment (informed consent) until hospital discharge or up to 40 days, whichever occurs first
Secondary outcomes (2)
Occurrence of Adverse Events (AEs)
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.
Measured: From enrollment until hospital discharge or up to 40 days
Length of Hospital Stay (LOS)
Number of days from study enrollment (informed consent) to hospital discharge or end of study.
Measured: From enrollment until discharge or up to 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start6 Nov 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798128
- Sponsor's protocol ID
- UCC-25AC025
- Acronym
- REDUCE
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No. Individual participant data (IPD) will not be shared. The study protocol does not include provisions for external sharing of participant-level data. Subject data will be pseudonymized and handled in accordance with applicable privacy regulations, including GDPR, and study results will be reported in aggregate form
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07798128
- Acronym / sponsor ID
- REDUCE / UCC-25AC025
- Conditions
- Urinary Incontinence, Limited Mobility
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (Indwelling Urinary Catheter) | – | Device: Indwelling Urinary Catheter (IUC)Participants managed for urinary incontinence using indwelling urinary catheters only, in accordance with routine clinical practice. |
| PureWick™ Flex Female External Catheter (FFEC) Implementation | – | Device: PureWick™ Flex Female External Catheter (FFEC), Device: Indwelling Urinary Catheter (IUC)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PureWick™ Flex Female External Catheter (FFEC)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. | Device | PureWick™ Flex Female External Catheter (FFEC) Implementation |
| Indwelling Urinary Catheter (IUC)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. | Device | PureWick™ Flex Female External Catheter (FFEC) Implementation, Standard of Care (Indwelling Urinary Catheter) |
Primary outcome
Indwelling Urinary Catheter (IUC) Utilization Rate
Time frame: 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.
2 secondary outcomes
Occurrence of Adverse Events (AEs)
Time frame: From enrollment until hospital discharge or up to 40 days
Length of Hospital Stay (LOS)
Time frame: From enrollment until discharge or up to 40 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No. No. Individual participant data (IPD) will not be shared. The study protocol does not include provisions for external sharing of participant-level data. Subject data will be pseudonymized and handled in accordance with applicable privacy regulations, including GDPR, and study results will be reported in aggregate form
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence and Limited Mobility, run by Becton, Dickinson and Company.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephan Hofmann (+49.160.105.3421, Stephan.Hofmann@bd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Indwelling Urinary Catheter (IUC) Utilization Rate (time frame: From enrollment (informed consent) until hospital discharge or up to 40 days, whichever occurs first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.