Nocturnal Enuresis Clinical Trial
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
Verified date | December 2023 |
Source | C. R. Bard |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 30 |
Est. completion date | May 9, 2024 |
Est. primary completion date | May 9, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Adult Female Participants >18 years of age at the time of signing the informed consent. 2. Currently use diapers or equivalent at night for urine capture ("Change complet"(French term)) 3. Willing to comply with all study procedures in this protocol 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. 10. Is under supervision of a legally authorized representative. |
Country | Name | City | State |
---|---|---|---|
France | CHU d'Angers, Universite d'Angers | Angers | |
France | Centre Hospitalier Universitaire de Lille | Lille | |
United States | Smiths Medical Center | Dunwoody | Georgia |
United States | Weill Cornell Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
C. R. Bard |
United States, France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Daily urine capture rate (percentage) | Urine weight captured in the device divided by the sum of urine weight captured in the device plus the leaked urine weight | Daily for 29 days during each treatment phase | |
Primary | Daily 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. | Daily for 29 days during each treatment phase | |
Secondary | 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 | Starting at baseline and then every 2 weeks during each treatment phase | |
Secondary | Participant's tolerability of device/treatment | Participant's tolerability will be determined by the number of days of actual use of both devices and the discontinuation rate attributed to the device's inconvenience to the participants. | Daily for 29 days during each treatment phase or until end of device use for each treatment phase | |
Secondary | Participant's comfort level associated with device/treatment | Overall comfort will determine by having the participants complete a survey with scores on a 5-point Likert scale collected at the end of each treatment phase | Daily use of for 29 days during each treatment phase and one survey collected at the end of each treatment phase | |
Secondary | Participant's opinion of ease of device/treament | Overall ease of use will determine by having the participants complete a survey with scores on a 5-point Likert scale collected at the end of each treatment phase. | Daily use of for 29 days during each treatment phase and one survey collected at the end of each treatment phase |
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