Urinary IncontinencePUREST-MNCT06850259
This Study Will Collect Clinical and Patient Reported Satisfaction Data From Males Requiring Urine Output Management Overnight in the Home Setting.
A study testing PureWick® Urine Collection System and UltraFlex™ Self-Adhering Male External Catheter in people with Urinary Incontinence, run by C. R. Bard at 2 sites in United States.
Trial summary
This post-market study will assess the performance of and user satisfaction with the PureWick® Male External Catheter in a home setting. The study will also observe safety of the study device and collect information from participants about their experience using the device. Read more about this study
- Who is it for?
- Ages 65 years and older, men only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- PureWick® Urine Collection System and UltraFlex™ Self-Adhering Male External Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Mar 2025to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years and older
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- Adult male participants ≥ 65 years of age at the time of signing the informed consent
- Male anatomy at the time of enrollment
- Currently use diapers, pads, or equivalent at night for urine output management
- Willing to comply with all study procedures in this protocol
- Provision of signed and dated informed consent form
Who cannot join
- Has frequent episodes of bowel incontinence; or
- Has chronic urinogenital infections, active genital herpes; or
- Has Urinary retention; or
- Has experience using study devices in the home setting within the last year; 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
- Any other condition that, in the opinion of the investigator, would preclude them from participating in the study; or
- Is considered a vulnerable population.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Finlay Medical Research
Greenacres City, Florida, 33467
Trialfinity Clinical Research Center
Hamilton, New Jersey, 08619
About this study
Official title: A Comparative Crossover Study on the Safety, Efficacy, and Patient Reported Satisfaction of the PureWick® System With an Established Comparator Overnight in the Home Setting for Incontinence in Adult Males
This post-market study will assess the performance of and user satisfaction with the PureWick® Male External Catheter in a home setting. The study will also observe safety of the study device and collect information from participants about their experience using the device.
Read the detailed description
Approximately 15 men requiring the use of diapers or pads at night for urine management will take part in this prospective, open-label, crossover trial. Participants will be 1:1 randomized to a treatment sequence using two devices: the PureWick® System (PureWick® Male External Catheter \& PureWick® Urine Collection System) and the UltraFlex™ Self-Adhering Male External Catheter. Participants will use each urine management device overnight while sleeping for a period of 7 days with a 2-day washout period in between. Total duration of participation is approximately 16 days. The primary efficacy endpoint is the mean capture rate. The primary safety endpoint is the number of device-related AEs requiring medical intervention. Capture rates and Adverse Events are assessed daily throughout each 7-day treatment phase. Sleep disturbance is assessed at baseline and every 7 days during treatment. End of study preference questionnaire is completed at the end of treatment. Device adherence is assessed by the proportion of device wear nights that the study device became dislodged. Tolerability is assessed by number of nights of actual device use.
- Conditions
- Urinary Incontinence
- Being tested
- PureWick® Urine Collection System, UltraFlex™ Self-Adhering Male External Catheter
- Keywords
- PureWick Urine Collection System, male external catheter, urinary incontinence, urine management, nocturia, nocturnal enuresis
- Medical subject headings
- Urinary Incontinence, Nocturia, Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PureWick® Urine Collection SystemDevice
The PureWick® System consists of the PureWick® Urine Collection System used with the PureWick™ Male External Catheter (MEC), which is intended for non-invasive urine output management in male patients. The PureWick® MEC is a single-use, non-sterile, commercially available device, which is Class I, 510(K) exempt.
UltraFlex™ Self-Adhering Male External CatheterDevice
UltraFlex™ is a self-adhering male external catheter used for the drainage of urine. The catheter is applied by the patient or caregiver. The self-adhering male external catheter is designed for the management of adult male urinary incontinence.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence 1 | Experimental | PureWick® Urine Collection System is used first, followed by cross-over to UltraFlex™ Self-Adhering Male External Catheter Receives: Device: PureWick® Urine Collection System; Device: UltraFlex™ Self-Adhering Male External Catheter |
| Treatment Sequence 2 | Experimental | UltraFlex™ Self-Adhering Male External Catheter is used first, followed by cross-over to PureWick® Urine Collection System Receives: Device: PureWick® Urine Collection System; Device: UltraFlex™ Self-Adhering Male External Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Daily Urine Capture Rate (Percentage) in the Home Setting
Capture rate following void (captured as % of urine captured by device and collected in canister, measured by weight).
Prior to each nightly use, the weight of the empty urine collection canister and the weight of a dry absorbent pad are collected. Participants use the device overnight while sleeping with the absorbent pad underneath them. The next morning, the post-void weight of the urine collection canister and the post-void weight of the absorbent pad are collected.
Capture rate is calculated as the weight of captured urine (post-void canister weight - pre-void canister weight) / total urine volume (captured urine (post-void canister weight - pre-void canister weight) + leaked urine (post-void pad weight - pre-void pad weight)) * 100.
Measured: Daily for 7 days during each treatment phase, up to 14 days post-baseline
Number of Device-related Adverse Events Requiring Medical Intervention
Number of device-related Adverse events requiring medical intervention, such as new prescription medication, surgery or procedure, or therapy ordered by a medical provider to treat or manage the adverse event, in each treatment group.
Measured: Daily for 7 days during each treatment phase, up to 14 days post-baseline
Secondary outcomes (3)
Participant Device Preference
Preference questionnaire administered after completion of both treatments to assess participant device satisfaction and preference for the PureWick MEC or UltraFlex sheath-style male external catheter. Participants will select which of the two devices they preferred and provide feedback on why the preferred device was selected.
Measured: After completion of both 7-day treatment phase or at the time of treatment discontinuation, whichever comes first, assessed up to 2 weeks
Participant Device Tolerance
Participant's tolerability is determined by the number of days of actual device use
Measured: After completion of each 7-day treatment phase or at the time of treatment discontinuation, whichever comes first, assessed up to 2 weeks
Device Adherence/Dislodgement
Proportion of device wear nights that each device became dislodged.
Measured: After completion of each 7-day treatment phase or at the time of treatment discontinuation, whichever comes first, assessed up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start21 Mar 2025
- Primary completion15 Jun 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Becton, Dickinson and Company
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850259
- Sponsor's protocol ID
- UCC-24HC013
- Acronym
- PUREST-M
- Status last verified
- Sep 2026
- First submitted
- 24 Feb 2025
- Last updated
- 21 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Crossover Study on the Safety, Efficacy, and Patient Reported Satisfaction of the PureWick® System With an Established Comparator Overnight in the Home Setting for Incontinence in Adult Males
- ClinicalTrials.gov ID
- NCT06850259
- Acronym / sponsor ID
- PUREST-M / UCC-24HC013
- Conditions
- Urinary Incontinence
- Keywords
- PureWick Urine Collection System, male external catheter, urinary incontinence, urine management, nocturia, nocturnal enuresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Collaborators
- Becton, Dickinson and Company
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 27 Feb 2025 (actual)
- Results
- Posted 21 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This post-market study will assess the performance of and user satisfaction with the PureWick® Male External Catheter in a home setting. The study will also observe safety of the study device and collect information from participants about their experience using the device.
Detailed description
Approximately 15 men requiring the use of diapers or pads at night for urine management will take part in this prospective, open-label, crossover trial. Participants will be 1:1 randomized to a treatment sequence using two devices: the PureWick® System (PureWick® Male External Catheter \& PureWick® Urine Collection System) and the UltraFlex™ Self-Adhering Male External Catheter. Participants will use each urine management device overnight while sleeping for a period of 7 days with a 2-day washout period in between. Total duration of participation is approximately 16 days. The primary efficacy endpoint is the mean capture rate. The primary safety endpoint is the number of device-related AEs requiring medical intervention. Capture rates and Adverse Events are assessed daily throughout each 7-day treatment phase. Sleep disturbance is assessed at baseline and every 7 days during treatment. End of study preference questionnaire is completed at the end of treatment. Device adherence is assessed by the proportion of device wear nights that the study device became dislodged. Tolerability is assessed by number of nights of actual device use.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence 1 | Experimental | Device: PureWick® Urine Collection System, Device: UltraFlex™ Self-Adhering Male External CatheterPureWick® Urine Collection System is used first, followed by cross-over to UltraFlex™ Self-Adhering Male External Catheter |
| Treatment Sequence 2 | Experimental | Device: PureWick® Urine Collection System, Device: UltraFlex™ Self-Adhering Male External CatheterUltraFlex™ Self-Adhering Male External Catheter is used first, followed by cross-over to PureWick® Urine Collection System |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Adult male participants ≥ 65 years of age at the time of signing the informed consent
- Male anatomy at the time of enrollment
- Currently use diapers, pads, or equivalent at night for urine output management
- Willing to comply with all study procedures in this protocol
- Provision of signed and dated informed consent form
Key exclusion criteria (8 listed)
- Has frequent episodes of bowel incontinence; or
- Has chronic urinogenital infections, active genital herpes; or
- Has Urinary retention; or
- Has experience using study devices in the home setting within the last year; or
- Is agitated, combative, and/or uncooperative and may remove the external catheter; 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 |
|---|---|---|
| PureWick® Urine Collection SystemThe PureWick® System consists of the PureWick® Urine Collection System used with the PureWick™ Male External Catheter (MEC), which is intended for non-invasive urine output management in male patients. The PureWick® MEC is a single-use, non-sterile, commercially available device, which is Class I, 510(K) exempt. | Device | Treatment Sequence 1, Treatment Sequence 2 |
| UltraFlex™ Self-Adhering Male External CatheterUltraFlex™ is a self-adhering male external catheter used for the drainage of urine. The catheter is applied by the patient or caregiver. The self-adhering male external catheter is designed for the management of adult male urinary incontinence. | Device | Treatment Sequence 1, Treatment Sequence 2 |
Primary outcome
Average Daily Urine Capture Rate (Percentage) in the Home Setting
Time frame: Daily for 7 days during each treatment phase, up to 14 days post-baseline
Capture rate following void (captured as % of urine captured by device and collected in canister, measured by weight). Prior to each nightly use, the weight of the empty urine collection canister and the weight of a dry absorbent pad are collected. Participants use the device overnight while sleeping with the absorbent pad underneath them. The next morning, the post-void weight of the urine collection canister and the post-void weight of the absorbent pad are collected. Capture rate is calculated as the weight of captured urine (post-void canister weight - pre-void canister weight) / total urine volume (captured urine (post-void canister weight - pre-void canister weight) + leaked urine (post-void pad weight - pre-void pad weight)) * 100.
Number of Device-related Adverse Events Requiring Medical Intervention
Time frame: Daily for 7 days during each treatment phase, up to 14 days post-baseline
Number of device-related Adverse events requiring medical intervention, such as new prescription medication, surgery or procedure, or therapy ordered by a medical provider to treat or manage the adverse event, in each treatment group.
3 secondary outcomes
Participant Device Preference
Time frame: After completion of both 7-day treatment phase or at the time of treatment discontinuation, whichever comes first, assessed up to 2 weeks
Participant Device Tolerance
Time frame: After completion of each 7-day treatment phase or at the time of treatment discontinuation, whichever comes first, assessed up to 2 weeks
Device Adherence/Dislodgement
Time frame: After completion of each 7-day treatment phase or at the time of treatment discontinuation, whichever comes first, assessed up to 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PureWick® Urine Collection System and UltraFlex™ Self-Adhering Male External Catheter in people with Urinary Incontinence, run by C. R. Bard at 2 sites in United States.
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 8 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: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 21 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Daily Urine Capture Rate (Percentage) in the Home Setting (time frame: Daily for 7 days during each treatment phase, up to 14 days post-baseline). The study lists 2 primary outcomes in all. 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 21 Oct 2026.