Adult Nocturnal EnuresisPURESTNCT06666426
This Study Will Collect Clinical and Patient Reported Experience Data From Participants Requiring Urine Output Management Overnight in the Home Setting.
A study testing PureWick System and Hollister Female Urinary Pouch External Collection Device in people with Adult Nocturnal Enuresis and Urinary Incontinence (UI), run by C. R. Bard at 15 sites in United States.
Trial summary
This post-market study will assess the performance of and user experience with the PureWick™ System in a home setting. The study will also observe safety of the study device and collect information from participants about their quality of life before and after using the device. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Adult Nocturnal Enuresis, Urinary Incontinence (UI)
- What is being tested?
- PureWick System and Hollister Female Urinary Pouch External Collection Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 15 sitesUnited States
- Study dates
- 31 Oct 2024to 30 Jun 2025
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Female Participants greater than or equal to 18 years of age at the time of signing the informed consent.
- Currently use diapers or equivalent at night for urine output management.
- Willing to comply with all study procedures in this CIP.
- Provision of signed and dated informed consent form.
Who cannot join
- 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 urinary tract, vaginal or other chronic infections, active genital herpes; or
- Has urinary retention; or
- Is agitated, combative, and/or uncooperative and may remove the external catheter or pouch; or
- Has any wound, open lesion or irritation on the genitalia, perineum, or sacrum; or
Show all 9Show fewer
- Has any pre-existing neurological, psychiatric, or other condition 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
- Any other condition that, in the opinion of the investigator, would preclude them from participating in the study.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102
New Horizons Clinical Trials
Chandler, Arizona, 85224
Revive Research Institute
Dearborn Heights, Michigan, 48127
Smith Medical Center
Dunwoody, Georgia, 30338
The Practice of Medicine INC.
Eagle Rock, California, 90041
Finlay Medical Research
Greenacres City, Florida, 33467
Lakeview Clinical Research
Guntersville, Alabama, 35976
Trialfinity Clinical Research Center
Hamilton, New Jersey, 08619
Trio Clinical Trials
Houston, Texas, 77008
Leavitt Clinical Research
Idaho Falls, Idaho, 83404
MultiSpecialty Clinical Research
Johnson City, Tennessee, 37604
Finlay Medical Research
Miami, Florida, 33126
Research Integrity
Owensboro, Kentucky, 42303
Sonar Clinical Research
Riverdale, Georgia, 30274
Prime Global Research
The Bronx, New York, 10456
About this study
Official title: A Randomized, Controlled Trial on the Safety, Efficacy, and Patient Reported Experience Comparing PureWick™ System With an Established Comparator Overnight in the Home Setting (PUREST)
This post-market study will assess the performance of and user experience with the PureWick™ System in a home setting. The study will also observe safety of the study device and collect information from participants about their quality of life before and after using the device.
Read the detailed description
Approximately 150 women with nighttime urinary incontinence will take part in this prospective, open-label, randomized trial. Participants will use one of two different study devices during the study to manage urine output at night: PureWick™ System or the Hollister® Female Urinary Pouch External Collection Device. Participant device assignment will be random. Participants will use the assigned urine management device overnight while sleeping and will be followed for approximately 4 weeks.
- Being tested
- PureWick System, Hollister Female Urinary Pouch External Collection Device
- Keywords
- nighttime urinary incontinence, Quality of Life, sleep disturbance, NQoL, PROMIS, Purewick, Hollister, females, PureWick Flex Female External Catheter, PureWick Urine Collection System, The Hollister Female Urinary Pouch, BD, Becton, Dickinson and Company
- Medical subject headings
- Nocturnal Enuresis, Urinary Incontinence, Parasomnias
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 Flex Female External Catheter, which are intended for non-invasive urine output management.
Hollister Female Urinary Pouch External Collection DeviceDevice
The Hollister Female Urinary Pouch External Collection Device is intended to collect and contain urine for individuals with urinary incontinence.
| Study group | Role | What they receive |
|---|---|---|
| Hollister | Active comparator | Not described Receives: Device: Hollister Female Urinary Pouch External Collection Device |
| PureWick | Experimental | Not described Receives: Device: PureWick System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the PureWick System in the home setting
Daily capture rate (captured as % of urine captured by device and collected in canister, measured by weight)
Measured: From enrollment to the end of treatment at 4 weeks
Safety of the PureWick System in the home setting
Daily skin irritation score using the 5-point Draize dermal irritation scoring system ranging from 0 to 4 with higher scores indicating greater irritation.
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (3)
Participant Device Tolerance
Number of days of actual device use over the expected treatment duration.
Measured: From enrollment to the end of treatment at 4 weeks
Participant Device Experience - Comfort
Overall comfort on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome.
Measured: From enrollment to the end of treatment at 4 weeks
Participant Device Experience - Ease of Use
Overall ease of use on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start31 Oct 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adult Nocturnal EnuresisStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 171 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
- NCT06666426
- Sponsor's protocol ID
- UCC-23HC009
- Acronym
- PUREST
- Status last verified
- Jul 2025
- First submitted
- 28 Oct 2024
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Medina JC, Fakih M, Khalsa S, Redmond D, Kennelly MJ. Safety, Efficacy, and Patient-Reported Outcomes of the PureWick System Versus Comparator for Nocturnal Urinary Incontinence in the Home Setting: Results of a Randomized Trial. J Clin Med. 2025 Dec 9;14(24):8699. doi: 10.3390/jcm14248699.
PubMed 41464602
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial on the Safety, Efficacy, and Patient Reported Experience Comparing PureWick™ System With an Established Comparator Overnight in the Home Setting (PUREST)
- ClinicalTrials.gov ID
- NCT06666426
- Acronym / sponsor ID
- PUREST / UCC-23HC009
- Keywords
- nighttime urinary incontinence, Quality of Life, sleep disturbance, NQoL, PROMIS, Purewick, Hollister, females
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Collaborators
- Becton, Dickinson and Company
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 30 Oct 2024 (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 experience with the PureWick™ System in a home setting. The study will also observe safety of the study device and collect information from participants about their quality of life before and after using the device.
Detailed description
Approximately 150 women with nighttime urinary incontinence will take part in this prospective, open-label, randomized trial. Participants will use one of two different study devices during the study to manage urine output at night: PureWick™ System or the Hollister® Female Urinary Pouch External Collection Device. Participant device assignment will be random. Participants will use the assigned urine management device overnight while sleeping and will be followed for approximately 4 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hollister | Active comparator | Device: Hollister Female Urinary Pouch External Collection Device |
| PureWick | Experimental | Device: PureWick System |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult Female Participants greater than or equal to 18 years of age at the time of signing the informed consent.
- Currently use diapers or equivalent at night for urine output management.
- Willing to comply with all study procedures in this CIP.
- Provision of signed and dated informed consent form.
Key exclusion criteria (9 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 urinary tract, vaginal or other chronic infections, active genital herpes; or
- Has urinary retention; or
- Is agitated, combative, and/or uncooperative and may remove the external catheter or pouch; 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 Flex Female External Catheter, which are intended for non-invasive urine output management. | Device | PureWick |
| Hollister Female Urinary Pouch External Collection DeviceThe Hollister Female Urinary Pouch External Collection Device is intended to collect and contain urine for individuals with urinary incontinence. | Device | Hollister |
Primary outcome
Performance of the PureWick System in the home setting
Time frame: From enrollment to the end of treatment at 4 weeks
Daily capture rate (captured as % of urine captured by device and collected in canister, measured by weight)
Safety of the PureWick System in the home setting
Time frame: From enrollment to the end of treatment at 4 weeks
Daily skin irritation score using the 5-point Draize dermal irritation scoring system ranging from 0 to 4 with higher scores indicating greater irritation.
3 secondary outcomes
Participant Device Tolerance
Time frame: From enrollment to the end of treatment at 4 weeks
Participant Device Experience - Comfort
Time frame: From enrollment to the end of treatment at 4 weeks
Participant Device Experience - Ease of Use
Time frame: From enrollment to the end of treatment at 4 weeks
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 24 Jul 2025.
- Derived from this study: PubMed 41464602Medina JC, Fakih M, Khalsa S, Redmond D, Kennelly MJ. Safety, Efficacy, and Patient-Reported Outcomes of the PureWick System Versus Comparator for Nocturnal Urinary Incontinence in the Home Setting: Results of a Randomized Trial. J Clin Med. 2025 Dec 9;14(24):8699. doi: 10.3390/jcm14248699.
- Individual participant dataSharing planned: No
Related trials for Adult Nocturnal Enuresis
Enrolling by invitationObservational study
Study of Transition in Real-life Experiences Affecting Micturition and Well-being in Adolescent Years
Lower Urinary Tract Symptoms (LUTS), Transition Care
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.
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 Hollister Female Urinary Pouch External Collection Device in people with Adult Nocturnal Enuresis and Urinary Incontinence (UI), 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 4 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 24 Jul 2025. 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?
Performance of the PureWick System in the home setting (time frame: From enrollment to the end of treatment at 4 weeks). 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?
On the ClinicalTrials.gov record for NCT06666426, which also lists 1 linked publication.
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 24 Jul 2025.