Urinary IncontinencePUREST-MNCT07282860
An Evaluation of the PureWick™ Male External Catheter Versus an Established Comparator Overnight in the Home Setting for Incontinence in Adult Males
A study testing PureWick System and UltraFlex Self-Adhering Male External Catheter in people with Urinary Incontinence, run by C. R. Bard at 15 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 18 years and older, men only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- PureWick 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
- 120 participants
- Where
- 15 sitesUnited States
- Study dates
- 21 Nov 2025to 22 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male participants ≥ 18 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
- Is expected to have an overnight urine output exceeding 1500 mL. This may include, but is not limited to, individuals with polyuria or those receiving diuretic therapy; 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
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- 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
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102
Sonar Clinical Research
Atlanta, Georgia, 30315
Eagle Clinical Research
Chicago, Illinois, 60621
Vida Clinical Studies
Dearborn Heights, Michigan, 48127
Finlay Medical Research
Greenacres City, Florida, 33467
Lakeview Clinical Research, LLC
Guntersville, Alabama, 35976
Trialfinity Clinical Research Center
Hamilton, New Jersey, 08619
Inno MDR Clinical
Hamilton, New Jersey, 08690
Trio Clinical Trials
Houston, Texas, 77008
R&H Clinical Research
Katy, Texas, 77494
American Institute of Research
Los Angeles, California, 90017
Finlay Medical Research
Miami, Florida, 33126
Monroe Biomedical Research
North Charleston, South Carolina, 29406
Prime Global Research
The Bronx, New York, 10456
Novak Clinical Research
Tucson, Arizona, 85741
About this study
Official title: A Randomized, Controlled Crossover Study on the Safety, Efficacy, and Patient Reported Outcome Measures Comparing 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 100 adult men requiring the use of diapers, pads or equivalent 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 endpoint is the mean urine capture rate. The secondary endpoints include the number of device-related AEs requiring medical intervention (safety), device satisfaction and preference questionnaires, and sleep disturbance (quality of life). Capture rates and adverse events are assessed daily throughout each 7-day treatment phase. Patient satisfaction is assessed at the end of each treatment phase. Patient preference is evaluated at study completion. Sleep disturbance is assessed at baseline and every 7 days during treatment.
- Conditions
- Urinary Incontinence
- Being tested
- PureWick System, UltraFlex Self-Adhering Male External Catheter
- Keywords
- Male External Catheter, Urine Output 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 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 System used first, followed by crossover to UltraFlex Receives: Device: PureWick System; Device: UltraFlex Self-Adhering Male External Catheter |
| Treatment Sequence 2 | Experimental | UltraFlex is used first, followed by crossover to PureWick System Receives: Device: PureWick 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.
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: From enrollment up to 14 days of treatment
Secondary outcomes (4)
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: From enrollment up to 14 days of treatment
Participant Device Satisfaction
Participant experience questionnaire administered after completion of each treatment phase to assess participant device satisfaction. Questions will be scored on a 3-point or 5-point Likert scale with higher scores indicating a better outcome.
Measured: Day 7 and Day 14, or at the time of treatment discontinuation, whichever comes first.
Participant Device Preference
Participant preference questionnaire administered after completion of both treatment phases to assess preference for the PureWick MEC or UltraFlex sheath-style male external catheter.
Measured: Day 15, or at the time of study discontinuation, whichever comes first.
Participant Sleep Quality
The PROMIS Sleep Disturbance Short Form 4a score collected at baseline and after each 7-day treatment phase. The PROMIS Sleep Disturbance 4a contains 4 scored items each scored from 1 to 5. All item raw scores are computed into a total score where higher scores indicate a worse outcome.
Measured: Starting at baseline and then after Day 7 and after Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start21 Nov 2025
- Primary completion22 Jun 2026
- Study completion22 Jun 2026
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.
- More trials run by C. R. BardThe sponsor's other registered studies.
- 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Becton, Dickinson and Company
- Responsible party
- Sponsor
- Investigators
- Adrian Wagg, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282860
- Sponsor's protocol ID
- UCC-25HC015
- Acronym
- PUREST-M
- Status last verified
- Jul 2026
- First submitted
- 24 Nov 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- 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 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Crossover Study on the Safety, Efficacy, and Patient Reported Outcome Measures Comparing the PureWick™ System With an Established Comparator Overnight in the Home Setting for Incontinence in Adult Males
- ClinicalTrials.gov ID
- NCT07282860
- Acronym / sponsor ID
- PUREST-M / UCC-25HC015
- Conditions
- Urinary Incontinence
- Keywords
- Male External Catheter, Urine Output Management, Nocturia, Nocturnal Enuresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Collaborators
- Becton, Dickinson and Company
- Study start
- 21 Nov 2025 (actual)
- Primary completion
- 22 Jun 2026 (actual)
- Study completion
- 22 Jun 2026 (actual)
- First posted
- 15 Dec 2025 (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.
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 100 adult men requiring the use of diapers, pads or equivalent 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 endpoint is the mean urine capture rate. The secondary endpoints include the number of device-related AEs requiring medical intervention (safety), device satisfaction and preference questionnaires, and sleep disturbance (quality of life). Capture rates and adverse events are assessed daily throughout each 7-day treatment phase. Patient satisfaction is assessed at the end of each treatment phase. Patient preference is evaluated at study completion. Sleep disturbance is assessed at baseline and every 7 days during treatment.
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 System, Device: UltraFlex Self-Adhering Male External CatheterPureWick System used first, followed by crossover to UltraFlex |
| Treatment Sequence 2 | Experimental | Device: PureWick System, Device: UltraFlex Self-Adhering Male External CatheterUltraFlex is used first, followed by crossover to PureWick System |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult male participants ≥ 18 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 (9 listed)
- Has frequent episodes of bowel incontinence; or
- Has chronic urinogenital infections, active genital herpes; or
- Has Urinary retention; or
- Is expected to have an overnight urine output exceeding 1500 mL. This may include, but is not limited to, individuals with polyuria or those receiving diuretic therapy; or
- Has experience using study devices in the home setting within the last year; 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 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
Capture rate following void (captured as % of urine captured by device and collected in canister, measured by weight).
Time frame: From enrollment up to 14 days of treatment
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.
4 secondary outcomes
Number of device-related adverse events requiring medical intervention
Time frame: From enrollment up to 14 days of treatment
Participant Device Satisfaction
Time frame: Day 7 and Day 14, or at the time of treatment discontinuation, whichever comes first.
Participant Device Preference
Time frame: Day 15, or at the time of study discontinuation, whichever comes first.
Participant Sleep Quality
Time frame: Starting at baseline and then after Day 7 and after Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- 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.
Adrian Wagg principal investigator
University of Alberta
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PureWick System and UltraFlex Self-Adhering Male External Catheter in people with Urinary Incontinence, run by C. R. Bard at 15 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 9 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 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Capture rate following void (captured as % of urine captured by device and collected in canister, measured by weight). (time frame: From enrollment up to 14 days of treatment). 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 4 Aug 2026.