Clinical trial NCT06666426: This Study Will Collect Clinical and Patient Reported Experience Data From Participants Requiring Urine Output Management Overnight in the Home Setting.
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)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Adult Nocturnal Enuresis
Urinary Incontinence (UI)
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
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
Collaborators: name: Becton, Dickinson and Company
First posted: 2024-10-30
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Performance of the PureWick System in the home setting
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Safety of the PureWick System in the home setting
timeFrame: From enrollment to the end of treatment at 4 weeks
Secondary outcomes:
measure: Participant Device Tolerance
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Participant Device Experience - Comfort
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Participant Device Experience - Ease of Use
timeFrame: From enrollment to the end of treatment at 4 weeks
Other outcomes:
measure: Nocturnal Incontinence related Quality of Life
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Participant Sleep Quality
timeFrame: From enrollment to the end of treatment at 4 weeks
Locations:
city: Guntersville
country: United States
facility: Lakeview Clinical Research
state: Alabama
city: Chandler
country: United States
facility: New Horizons Clinical Trials
state: Arizona
city: Eagle Rock
country: United States
facility: The Practice of Medicine INC.
state: California
city: Greenacres City
country: United States
facility: Finlay Medical Research
state: Florida
city: Miami
country: United States
facility: Finlay Medical Research
state: Florida
city: Dunwoody
country: United States
facility: Smith Medical Center
state: Georgia
city: Riverdale
country: United States
facility: Sonar Clinical Research
state: Georgia
city: Idaho Falls
country: United States
facility: Leavitt Clinical Research
state: Idaho
city: Owensboro
country: United States
facility: Research Integrity
state: Kentucky
city: Dearborn Heights
country: United States
facility: Revive Research Institute
state: Michigan
city: Hamilton
country: United States
facility: Trialfinity Clinical Research Center
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials
state: New Mexico
city: Bronx
country: United States
facility: Prime Global Research
state: New York
city: Johnson City
country: United States
facility: MultiSpecialty Clinical Research
state: Tennessee
city: Houston
country: United States
facility: Trio Clinical Trials
state: Texas
Study officials:
References: