Adult Nocturnal Enuresis, Urinary Incontinence (UI)
Conditions
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
Brief 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.
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.
Interventions
DEVICEPureWick System
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.
DEVICEHollister Female Urinary Pouch External Collection Device
The Hollister Female Urinary Pouch External Collection Device is intended to collect and contain urine for individuals with urinary incontinence.
Sponsors
Becton, Dickinson and Company
C. R. Bard
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult Female Participants greater than or equal to 18 years of age at the time of signing the informed consent. 2. Currently use diapers or equivalent at night for urine output management. 3. Willing to comply with all study procedures in this CIP. 4. Provision of signed and dated informed consent form.
Exclusion criteria
1. Has frequent episodes of bowel incontinence without a fecal management system in place; or 2. Has moderate to heavy menstruation and cannot use a tampon or menstrual cup; or 3. Has urinary tract, vaginal or other chronic infections, active genital herpes; or 4. Has urinary retention; or 5. Is agitated, combative, and/or uncooperative and may remove the external catheter or pouch; or 6. Has any wound, open lesion or irritation on the genitalia, perineum, or sacrum; or 7. 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 8. Is known to be pregnant at time of enrollment (for women of childbearing age); or 9. Any other condition that, in the opinion of the investigator, would preclude them from participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance of the PureWick System in the home setting | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Device Experience - Ease of Use | From enrollment to the end of treatment at 4 weeks | Overall ease of use on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome. |
| Participant Device Experience - Comfort | From enrollment to the end of treatment at 4 weeks | Overall comfort on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome. |
| Participant Device Tolerance | From enrollment to the end of treatment at 4 weeks | Number of days of actual device use over the expected treatment duration. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Nocturnal Incontinence related Quality of Life | From enrollment to the end of treatment at 4 weeks | Nocturia Quality of Life (N-QOL) score collected at baseline and every 2 weeks during treatment with higher scores indicating better QoL. The NQoL contains 12 scored items each scored from 0 to 4. All item scores are computed into a total score ranging from 0-100 where 0 is the worst QoL and 100 is the best QoL. |
| Participant Sleep Quality | From enrollment to the end of treatment at 4 weeks | PROMIS Sleep Disturbance Short Form 4a score collected at baseline and every 7 days during treatment with higher scores indicating greater sleep disturbance. 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. |
Countries
United States
Outcome results
None listed