Nocturnal EnuresisNCT05710718
PureWick™ France and U.S. At-Home Pilot Study
A study testing PureWick™ System and Hollister® Female Urinary Pouch External Collection Device in people with Nocturnal Enuresis, run by C. R. Bard at 2 sites in United States.
Trial summary
In this prospective, post-market, multi-site, open-label, crossover trial, women with urinary incontinence requiring the use of diapers (changes complets (French term)) at night will be 1:1 randomized to a treatment sequence using two devices (PureWick™ System and Hollister® Female Urinary Pouch External Collection… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Nocturnal Enuresis
- 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
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Oct 2023to 25 Aug 2024
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Female Participants >18 years of age at the time of signing the informed consent.
- Currently use diapers or equivalent at night for urine capture ("Change complet"(French term))
- Willing to comply with all study procedures in the protocol
- 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 10Show 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.
- Is under supervision of a legally authorized representative.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Smiths Medical Center
Dunwoody, Georgia, 30338
Weill Cornell Medical Center
New York, New York, 10065
About this study
Official title: A Comparative Crossover Study on the Safety, Efficacy, and Patient Quality of Life Comparing PureWick™ System With an Established Comparator in the Home Setting for Incontinence Overnight
In this prospective, post-market, multi-site, open-label, crossover trial, women with urinary incontinence requiring the use of diapers (changes complets (French term)) at night will be 1:1 randomized to a treatment sequence using two devices (PureWick™ System and Hollister® Female Urinary Pouch External Collection Device) and followed for approximately 10 weeks through 2 treatment phases. The primary objectives are to evaluate safety (skin injury) and efficacy (capture rate). Safety will be assessed using the Draize Scale and efficacy will be measured based on daily urine capture rate.
Read the detailed description
In this prospective, post-market, multi-site, open-label, crossover trial, women with urinary incontinence requiring the use of diapers (changes complets (French term)) at night will be 1:1 randomized to a treatment sequence using two devices (PureWick™ System and Hollister® Female Urinary Pouch External Collection Device) and followed for approximately 10 weeks through 2 treatment phases.
Approximately 30 female participants from 2 sites will be enrolled into the study. Those meeting eligibility criteria will be treated according to the treatment sequence assigned during randomization. Participants will view the standardized training video for the applicable product at the beginning of each treatment phase and have access to the Information for Use document (IFU) to review during each treatment phase. The total expected duration of subject participation is approximately 10 weeks. Participants will use the device assigned in treatment phase 1 overnight while sleeping for 4 weeks (28 days) before transitioning to the second assigned device in treatment phase 2. There will be a minimum washout period of 2 weeks (not to exceed 4 weeks) between treatment phases and a re-screening of eligibility criteria before the second phase. In both treatment phases, participants will independently place and remove the FEC (female external catheter) or FUP (Female Urinary Pouch) after standardized teaching is completed on the first day of the treatment phase.
The primary objectives are to evaluate safety (skin injury) and efficacy (capture rate). Safety will be assessed using the Draize Scale and efficacy will be measured based on daily urine capture rate. Health Care Providers (HCPs) will visit participants' homes daily to perform a skin assessment and collect urine measurements during the treatment phases. Participants will be withdrawn from the treatment phase if grade 4 is achieved in any category on the Draize skin irritation scale.
The secondary objectives are to assess quality of life, tolerability, comfort and ease of use. Quality of life and comfort and ease of use will be measured using self-reported changes in quality of life via the validated Nocturia Quality of Life (N-Qol) tool \& the PROMIS Sleep Disturbance Short-form 4a survey, and subjective evaluation of the therapy via participant survey, respectively. Tolerability will be measured by number of days of actual use of both devices, and discontinuation rate attributed to the device's discomfort or inconvenience.
- Conditions
- Nocturnal Enuresis
- Being tested
- PureWick™ System, Hollister® Female Urinary Pouch External Collection Device
- Medical subject headings
- 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™ FEC is intended for non-invasive urine output management in female patients. The PureWick™ FEC is a flexible, contoured external catheter that is positioned against the area where urine exits the female body. The PureWick™ FEC is connected to the PureWick™ Urine Collection System (PUCS) via connector tubing. The PUCS uses suction (not felt by the user) to pull voided urine through the device, regardless of the urine flow rate. Urine continues through vinyl tubing until it reaches a collection canister, away from the body.
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. It is designed to be emptied and should be attached to a drainage bag. The FUP is made with hydrocolloid skin adhesive and polymer/copolymer plastics.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence 1 | Other | The PureWick™ System is used for the first 4 weeks, followed by cross-over to the Hollister Female Urinary Pouch. Receives: Device: PureWick™ System; Device: Hollister® Female Urinary Pouch External Collection Device |
| Treatment Sequence 2 | Other | The Hollister Female Urinary Pouch is used for the first 4 weeks, followed by cross-over to the PureWick™ System. Receives: Device: PureWick™ System; Device: Hollister® Female Urinary Pouch External Collection Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Average Urine Capture Rate (Percentage)
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.
The primary efficacy endpoint of urine capture rate is derived by computing the mean of daily capture rate during each study phase.
Measured: Daily for 28 days during each treatment phase
Daily Average Skin Irritation Score Using the Draize Scale
Draize Scale is a 5 point scale where 0 is no erythema, edema, or bleeding and 4 is severe erythema, edema, and/or bleeding.
The primary safety endpoint of skin irritation score is derived by computing the mean of Draize Scale scores assessed daily during each study phase.
Measured: Daily for 28 days during each treatment phase
Secondary outcomes (5)
Nocturia Quality of Life (N-QOL) Score
N-QOL is a standardized tool used to explore 13 items that might be affected by nocturia (e.g., concentration, productiveness, and low energy). Transformed Total Score is computed from the core 12 item summary scores and ranges from 0-100 with higher scores indicating better quality of life.
Measured: Starting at baseline and then every 2 weeks during each treatment phase
PROMIS Sleep Disturbance - Short Form 4a Score
The PROMIS Sleep Disturbance Short Form 4a consists of 4 questions that each have 5 response options, with 1 indicating the least sleep disturbance and 5 indicating the most sleep disturbance. Total raw scores are translated into a T-score ranging from 32.0 to 73.3, with higher scores indicating worse outcome.
Measured: Starting at baseline and then every 7 days during each treatment phase
Participant's Tolerability of Device/Treatment
Participant's tolerability is determined by the number of days of actual device use.
Measured: After completion of the 28-day treatment phase or at the time of treatment discontinuation, whichever comes first.
Participant's Comfort Level Associated With Device/Treatment
Overall comfort on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome, where 1 = Very Uncomfortable, 2 = Uncomfortable, 3 = Neither Comfortable nor Uncomfortable, 4 = Comfortable, and 5 = Very Comfortable.
The last question related to likelihood to recommend the device ranged from 1-5 with higher scores indicating a better outcome, where 1 = Very Unlikely, 2 = Unlikely, 3 = Neither Likely nor Unlikely, 4 = Likely, and 5 = Very Likely.
Measured: After completion of each 28-day treatment phase or at the time of treatment discontinuation, whichever comes first.
Participant's Opinion of Ease of Device Use
Ease of use score on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome, where 1 = Very Difficult, 2 = Somewhat Difficult, 3 = Average Difficulty, 4 = Somewhat Easy, and 5 = Very Easy.
The last question related to dryness experienced with the device during sleep ranged from 1-4 with higher scores indicating a better outcome, where 1 = Never Dry, 2 = Sometimes Dry, 3 = Usually Dry, 4 = Always dry to mostly always dry
Measured: After completion of each 28-day treatment phase or at the time of treatment discontinuation, whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start31 Oct 2023
- Primary completion25 Aug 2024
- Study completion25 Aug 2024
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 Nocturnal EnuresisStudies 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
- Model description
- 1:1 Crossover
- Masking
- None (open label)
- Enrolment
- 17 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
- NCT05710718
- Sponsor's protocol ID
- UCC-8007
- Status last verified
- May 2025
- First submitted
- 4 Jan 2023
- Last updated
- 16 Jul 2025
- 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 16 Jul 2025. 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 Quality of Life Comparing PureWick™ System With an Established Comparator in the Home Setting for Incontinence Overnight
- ClinicalTrials.gov ID
- NCT05710718
- Acronym / sponsor ID
- UCC-8007
- Conditions
- Nocturnal Enuresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Collaborators
- Becton, Dickinson and Company
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 25 Aug 2024 (actual)
- Study completion
- 25 Aug 2024 (actual)
- First posted
- 2 Feb 2023 (actual)
- Results
- Posted 16 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this prospective, post-market, multi-site, open-label, crossover trial, women with urinary incontinence requiring the use of diapers (changes complets (French term)) at night will be 1:1 randomized to a treatment sequence using two devices (PureWick™ System and Hollister® Female Urinary Pouch External Collection Device) and followed for approximately 10 weeks through 2 treatment phases. The primary objectives are to evaluate safety (skin injury) and efficacy (capture rate). Safety will be assessed using the Draize Scale and efficacy will be measured based on daily urine capture rate.
Detailed description
In this prospective, post-market, multi-site, open-label, crossover trial, women with urinary incontinence requiring the use of diapers (changes complets (French term)) at night will be 1:1 randomized to a treatment sequence using two devices (PureWick™ System and Hollister® Female Urinary Pouch External Collection Device) and followed for approximately 10 weeks through 2 treatment phases.
Approximately 30 female participants from 2 sites will be enrolled into the study. Those meeting eligibility criteria will be treated according to the treatment sequence assigned during randomization. Participants will view the standardized training video for the applicable product at the beginning of each treatment phase and have access to the Information for Use document (IFU) to review during each treatment phase. The total expected duration of subject participation is approximately 10 weeks. Participants will use the device assigned in treatment phase 1 overnight while sleeping for 4 weeks (28 days) before transitioning to the second assigned device in treatment phase 2. There will be a minimum washout period of 2 weeks (not to exceed 4 weeks) between treatment phases and a re-screening of eligibility criteria before the second phase. In both treatment phases, participants will independently place and remove the FEC (female external catheter) or FUP (Female Urinary Pouch) after standardized teaching is completed on the first day of the treatment phase.
The primary objectives are to evaluate safety (skin injury) and efficacy (capture rate). Safety will be assessed using the Draize Scale and efficacy will be measured based on daily urine capture rate. Health Care Providers (HCPs) will visit participants' homes daily to perform a skin assessment and collect urine measurements during the treatment phases. Participants will be withdrawn from the treatment phase if grade 4 is achieved in any category on the Draize skin irritation scale.
The secondary objectives are to assess quality of life, tolerability, comfort and ease of use. Quality of life and comfort and ease of use will be measured using self-reported changes in quality of life via the validated Nocturia Quality of Life (N-Qol) tool \& the PROMIS Sleep Disturbance Short-form 4a survey, and subjective evaluation of the therapy via participant survey, respectively. Tolerability will be measured by number of days of actual use of both devices, and discontinuation rate attributed to the device's discomfort or inconvenience.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 Crossover
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence 1 | Other | Device: PureWick™ System, Device: Hollister® Female Urinary Pouch External Collection DeviceThe PureWick™ System is used for the first 4 weeks, followed by cross-over to the Hollister Female Urinary Pouch. |
| Treatment Sequence 2 | Other | Device: PureWick™ System, Device: Hollister® Female Urinary Pouch External Collection DeviceThe Hollister Female Urinary Pouch is used for the first 4 weeks, followed by cross-over to the 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 >18 years of age at the time of signing the informed consent.
- Currently use diapers or equivalent at night for urine capture ("Change complet"(French term))
- Willing to comply with all study procedures in the protocol
- Provision of signed and dated informed consent form
Key exclusion criteria (10 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™ FEC is intended for non-invasive urine output management in female patients. The PureWick™ FEC is a flexible, contoured external catheter that is positioned against the area where urine exits the female body. The PureWick™ FEC is connected to the PureWick™ Urine Collection System (PUCS) via connector tubing. The PUCS uses suction (not felt by the user) to pull voided urine through the device, regardless of the urine flow rate. Urine continues through vinyl tubing until it reaches a collection canister, away from the body. | Device | Treatment Sequence 1, Treatment Sequence 2 |
| 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. It is designed to be emptied and should be attached to a drainage bag. The FUP is made with hydrocolloid skin adhesive and polymer/copolymer plastics. | Device | Treatment Sequence 1, Treatment Sequence 2 |
Primary outcome
Daily Average Urine Capture Rate (Percentage)
Time frame: Daily for 28 days during each treatment phase
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. The primary efficacy endpoint of urine capture rate is derived by computing the mean of daily capture rate during each study phase.
Daily Average Skin Irritation Score Using the Draize Scale
Time frame: Daily for 28 days during each treatment phase
Draize Scale is a 5 point scale where 0 is no erythema, edema, or bleeding and 4 is severe erythema, edema, and/or bleeding. The primary safety endpoint of skin irritation score is derived by computing the mean of Draize Scale scores assessed daily during each study phase.
5 secondary outcomes
Nocturia Quality of Life (N-QOL) Score
Time frame: Starting at baseline and then every 2 weeks during each treatment phase
PROMIS Sleep Disturbance - Short Form 4a Score
Time frame: Starting at baseline and then every 7 days during each treatment phase
Participant's Tolerability of Device/Treatment
Time frame: After completion of the 28-day treatment phase or at the time of treatment discontinuation, whichever comes first.
Participant's Comfort Level Associated With Device/Treatment
Time frame: After completion of each 28-day treatment phase or at the time of treatment discontinuation, whichever comes first.
Participant's Opinion of Ease of Device Use
Time frame: After completion of each 28-day treatment phase or at the time of treatment discontinuation, whichever comes first.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- 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™ System and Hollister® Female Urinary Pouch External Collection Device in people with Nocturnal Enuresis, 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 4 inclusion and 10 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 16 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 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 16 Jul 2025). 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?
Daily Average Urine Capture Rate (Percentage) (time frame: Daily for 28 days during each treatment phase). 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 16 Jul 2025.