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

NCT07798128 | Not Yet Recruiting

• 1 other identifier: UCC-25AC025
• Study Type: observational
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief 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), 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.

Conditions

Urinary Incontinence; Limited Mobility

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment (informed consent) until hospital discharge or up to 40 days, whichever occurs first

Secondary Outcomes (2)

• Occurrence of Adverse Events (AEs)

  From enrollment until hospital discharge or up to 40 days

• Length of Hospital Stay (LOS)

  From enrollment until discharge or up to 40 days

Other Outcomes (4)

• Patient and Healthcare Professional (HCP) Assessment of Device Use

  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

  Baseline through discharge or Day 40.

• Sleep Disturbance

  Assessed at baseline, Day 7, Day 14, Day 28, and at hospital discharge or Day 40, whichever occurs first.

Study Arms (2)

Standard of Care (Indwelling Urinary Catheter)

Participants managed for urinary incontinence using indwelling urinary catheters only, in accordance with routine clinical practice.

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.

Device: PureWick™ Flex Female External Catheter (FFEC); Device: Indwelling Urinary Catheter (IUC)

Interventions

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.

PureWick™ Flex Female External Catheter (FFEC) Implementation

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.

PureWick™ Flex Female External Catheter (FFEC) Implementation; Standard of Care (Indwelling Urinary Catheter)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Becton, Dickinson and Company: lead

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Stephan Hofmann

CONTACT

+49.160.105.3421; Stephan.Hofmann@bd.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: September 1, 2026
• Study Start (Estimated): November 6, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share