N/A
N=13
PureWick™ France and U.S. At-Home Pilot Study
Nocturnal Enuresis
Bottom Line
View on ClinicalTrials.gov: NCT05710718 ↗Enrolled (actual)
13
Serious AEs
12.5%
Results posted
Jul 2025
Primary outcome: Primary: Daily Average Urine Capture Rate (Percentage) — 79.3; 34.3; 82.4; 24.2 Percentage of urine captured — p=0.076
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PureWick™ System (Device); Hollister® Female Urinary Pouch External Collection Device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- C. R. Bard
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Daily Average Urine Capture Rate (Percentage) |
79.3; 34.3; 82.4; 24.2; 75.6; 49.4 | 0.076 |
| PRIMARY Daily Average Skin Irritation Score Using the Draize Scale |
0.06; 0.03 | — |
| SECONDARY Nocturia Quality of Life (N-QOL) Score |
54.4; 55.7; 60.0; 64.6; 6.7; 15.6 | — |
| SECONDARY PROMIS Sleep Disturbance - Short Form 4a Score |
57.9; 54.3; 52.4; 59.8; -5.5; 5.5 | — |
| SECONDARY Participant's Tolerability of Device/Treatment |
23.8; 10.7; 23.2; 22.0 | — |
| SECONDARY Participant's Comfort Level Associated With Device/Treatment |
4.3; 2.5; 4.2; 3.0; 4.3; 1.0 | — |
| SECONDARY Participant's Opinion of Ease of Device Use |
4.4; 2.0; 4.4; 2.0; 2.8; 1.3 | — |
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 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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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.
Data sourced from ClinicalTrials.gov (NCT05710718). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.