Urinary IncontinenceNCT07555548
UK PureWick™ At-Home Pilot Study
An observational study of Urinary Incontinence, run by Becton, Dickinson and Company at 4 sites in United Kingdom.
Trial summary
The UK PureWick™ At-Home Study is being carried out to see how well the PureWick™ Collection System works for women who use it at home instead of a traditional catheter. Traditional catheters are placed inside the body. The PureWick™ Collection System is different, it's placed outside the body . Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Treatment with the PureWick™ Urine Collection System External Catheter which is a non-invasive device designed to manage urinary incontinence
- Type of treatment
- Surgery or procedure
- How many people
- 95 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 6 May 2026to Jan 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: Female patients managed in a home care setting.
Who may be able to join
- Adult Female Subjects >18 years of age at the time of signing the informed consent.
- Treated with indwelling catheters for at least four weeks
- Encountered "problematic catheters" necessitating a minimum of five interventions within the past month, involving medical treatment and HCP consultation;
- Willing to comply with all study procedures in this protocol
- The subject (or subject's power of attorney) must be willing and able to read, understand, sign, and date the informed consent form.
Who cannot join
- Subjects are excluded from the study if any of the following criteria apply:
- Has frequent episodes of bowel incontinence without a fecal management system in place; or
- Has moderate to heavy menstruation and cannot use a tampon or menstrual cup; or
- Has vaginal or other chronic non-urinary tract infections (UTIs), active genital herpes; or
- Is agitated, combative, and/or uncooperative and may remove the external catheter; or
- Has any wound, open lesion or irritation on the genitalia, perineum, or sacrum; or
Show all 11Show fewer
- 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; or
- Is known to be pregnant at time of enrollment (for women of childbearing age); or
- Has a confirmed diagnosis of urinary tract infection at the time of enrollment.
- Subjects with a urine output of ≥1800 mL over a 12-hour period who, or whose caregivers, are unable to independently empty the collection canister.
- Any other condition that, in the opinion of the investigator, would preclude them from participating in the study.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom4 sites, 4 recruiting
- Recruiting
Rotherham Doncaster and South Humber NHS Foundation Trust
Doncaster
Donna Atkinson, 03000218996, donna.atkinson@nhs.net
- Recruiting
South Leicestershire Medical Group
Leicester
Anuj Chahal, +44 (0)7833349328, anuj.chahal1@nhs.net
- Recruiting
NCAS- Northamptonshire Continence Advisory Service
Northampton, NN3 6NP
Rebecca Willis, +447874882910, Rebecca.Willis@nhft.nhs.uk
- Recruiting
East of England Community Health and Care NHS Trust
Norwich, NR2 4BX
Laura Towers, 01603 272251, Laura.Towers@nchc.nhs.uk
About this study
Official title: An Open-label Pilot Study Conducted in the UK to Evaluate the Clinical Benefits of the PureWick™ Female External Catheter System Compared to Indwelling Urinary Catheters in Female Patients Receiving Home-based Care
The UK PureWick™ At-Home Study is being carried out to see how well the PureWick™ Collection System works for women who use it at home instead of a traditional catheter. Traditional catheters are placed inside the body. The PureWick™ Collection System is different, it's placed outside the body .
In this study, researchers want to find out: how effective the PureWick™ Collection System is in helping women manage urine collection at home, whether patients prefer using PureWick™ Collection System over the usual catheter, how it affects their sleep, and overall well-being.The PureWick™ Collection System is intended for the treatment of patients who leak urine (called urine incontinence). The PureWick™ Collection System is designed to help manage urine in female patients without needing to insert a urinary catheter into the body.
Read the detailed description
This is a combination of a retrospective / prospective, open-label, pilot study which aims to assess the clinical benefits of the PureWick™ Female External Catheter System compared to indwelling urinary catheters in female patients managed in a home care setting.
After enrollment in the study, the preceding 4 weeks will be retrospectively assessed for subjects who encountered "problematic catheters" necessitating a minimum of five interventions within the past month, involving medical treatment and HCP consultation. Following a one-week familiarization period, a four-week prospective phase will commence during which subjects will utilize the PureWick™ Female External Catheter System.
The familiarization period will serve as a training phase, allowing both subjects and caregivers to receive instruction and adapt to the use of the study device.
- Conditions
- Urinary Incontinence
- Being tested
- Treatment with the PureWick™ Urine Collection System External Catheter which is a non-invasive device designed to manage urinary incontinence
- Keywords
- UTI
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with the PureWick™ Urine Collection System External Catheter which is a non-invasive device designed to manage urinary incontinenceProcedure or surgery
After enrollment in the study, the preceding 4 weeks will be retrospectively assessed for subjects who encountered "problematic catheters" necessitating a minimum of five interventions within the past month, involving medical treatment and HCP consultation. Following a one-week familiarization period, a four-week prospective phase will commence during which subjects will utilize the PureWick™ Female External Catheter System.
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective assessment of the clinical impact of problematic indwelling urinary catheters requiring intervention versus the clinical impact with the use of the PureWick™ System requiring intervention, documented during a prospective 4-week study period
Retrospective assessment of the clinical impact of problematic indwelling urinary catheters requiring intervention by the treating HCP, based on medical records from the 4-week period preceding subject enrollment versus the clinical impact with the use of the PureWick™ System requiring intervention by the treating HCP during the prospective 4-week study period.
- Clinical impact for indwelling urinary catheters is defined as frequency and type of catheter-related problems such as infections, blockages, dislodgements, leakages, expulsion and bypassing, requiring intervention
- Clinical impact with the use of the PureWick™ System is defined as frequency and types of PureWick™ System-related problems such as infections, leakages, dislodgements, and replacements, requiring intervention.
- Subject-reported impact on daily activities measured by procedure and device related Adverse Events
- Health Care interventions required due to catheter-related issues incl. nursing time versus
Measured: From enrollment to the end of treatment at 5 weeks
Secondary outcomes (1)
To compare the possible pain intensity between subjects treated with the PureWick™ System and those with problematic indwelling urinary catheters
- Comparison of the pain intensity measured with the Numeric Pain Rating Scale associated with the PureWick™ System, prospectively documented over a 4-week observation period, versus the retrospectively recorded 4-week associated with indwelling urinary catheters. The Numeric Pain Rating score rates from 0 to 10, whereby 0 represents no pain and 10 worst possible pain.
Measured: From enrollment to the end of treatment at 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start6 May 2026
- Primary completionNov 2026 (estimated)
- Study completionJan 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
- Other
- Enrolment
- 95 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
- NCT07555548
- Sponsor's protocol ID
- UCC-24HC014
- Status last verified
- Jul 2026
- First submitted
- 19 Dec 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Pilot Study Conducted in the UK to Evaluate the Clinical Benefits of the PureWick™ Female External Catheter System Compared to Indwelling Urinary Catheters in Female Patients Receiving Home-based Care
- ClinicalTrials.gov ID
- NCT07555548
- Acronym / sponsor ID
- UCC-24HC014
- Conditions
- Urinary Incontinence
- Keywords
- UTI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- 6 May 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 29 Apr 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.
The UK PureWick™ At-Home Study is being carried out to see how well the PureWick™ Collection System works for women who use it at home instead of a traditional catheter. Traditional catheters are placed inside the body. The PureWick™ Collection System is different, it's placed outside the body .
In this study, researchers want to find out: how effective the PureWick™ Collection System is in helping women manage urine collection at home, whether patients prefer using PureWick™ Collection System over the usual catheter, how it affects their sleep, and overall well-being.The PureWick™ Collection System is intended for the treatment of patients who leak urine (called urine incontinence). The PureWick™ Collection System is designed to help manage urine in female patients without needing to insert a urinary catheter into the body.
Detailed description
This is a combination of a retrospective / prospective, open-label, pilot study which aims to assess the clinical benefits of the PureWick™ Female External Catheter System compared to indwelling urinary catheters in female patients managed in a home care setting.
After enrollment in the study, the preceding 4 weeks will be retrospectively assessed for subjects who encountered "problematic catheters" necessitating a minimum of five interventions within the past month, involving medical treatment and HCP consultation. Following a one-week familiarization period, a four-week prospective phase will commence during which subjects will utilize the PureWick™ Female External Catheter System.
The familiarization period will serve as a training phase, allowing both subjects and caregivers to receive instruction and adapt to the use of the study device.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients managed in a home care setting.
Key inclusion criteria (5 listed)
- Adult Female Subjects >18 years of age at the time of signing the informed consent.
- Treated with indwelling catheters for at least four weeks
- Encountered "problematic catheters" necessitating a minimum of five interventions within the past month, involving medical treatment and HCP consultation;
- Willing to comply with all study procedures in this protocol
- The subject (or subject's power of attorney) must be willing and able to read, understand, sign, and date the informed consent form.
Key exclusion criteria (11 listed)
- Has frequent episodes of bowel incontinence without a fecal management system in place; or
- Has moderate to heavy menstruation and cannot use a tampon or menstrual cup; or
- Has vaginal or other chronic non-urinary tract infections (UTIs), active genital herpes; or
- Is agitated, combative, and/or uncooperative and may remove the external catheter; or
- Has any wound, open lesion or irritation on the genitalia, perineum, or sacrum; or
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 |
|---|---|---|
| Treatment with the PureWick™ Urine Collection System External Catheter which is a non-invasive device designed to manage urinary incontinenceAfter enrollment in the study, the preceding 4 weeks will be retrospectively assessed for subjects who encountered "problematic catheters" necessitating a minimum of five interventions within the past month, involving medical treatment and HCP consultation. Following a one-week familiarization period, a four-week prospective phase will commence during which subjects will utilize the PureWick™ Female External Catheter System. | Procedure or surgery | – |
Primary outcome
Retrospective assessment of the clinical impact of problematic indwelling urinary catheters requiring intervention versus the clinical impact with the use of the PureWick™ System requiring intervention, documented during a prospective 4-week study period
Time frame: From enrollment to the end of treatment at 5 weeks
Retrospective assessment of the clinical impact of problematic indwelling urinary catheters requiring intervention by the treating HCP, based on medical records from the 4-week period preceding subject enrollment versus the clinical impact with the use of the PureWick™ System requiring intervention by the treating HCP during the prospective 4-week study period. * Clinical impact for indwelling urinary catheters is defined as frequency and type of catheter-related problems such as infections, blockages, dislodgements, leakages, expulsion and bypassing, requiring intervention * Clinical impact with the use of the PureWick™ System is defined as frequency and types of PureWick™ System-related problems such as infections, leakages, dislodgements, and replacements, requiring intervention. * Subject-reported impact on daily activities measured by procedure and device related Adverse Events * Health Care interventions required due to catheter-related issues incl. nursing time versus
1 secondary outcome
To compare the possible pain intensity between subjects treated with the PureWick™ System and those with problematic indwelling urinary catheters
Time frame: From enrollment to the end of treatment at 5 weeks
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 13 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence, run by Becton, Dickinson and Company at 4 sites in United Kingdom.
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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Winfried Huesmann (+4915154403197, winfried.huesmann@bd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective assessment of the clinical impact of problematic indwelling urinary catheters requiring intervention versus the clinical impact with the use of the PureWick™ System requiring intervention, documented during a prospective 4-week study period (time frame: From enrollment to the end of treatment at 5 weeks). 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 13 Jul 2026.