Clinical trial NCT06850259: This Study Will Collect Clinical and Patient Reported Satisfaction Data From Males Requiring Urine Output Management Overnight in the Home Setting.
Official title: A Comparative Crossover Study on the Safety, Efficacy, and Patient Reported Satisfaction of the PureWick™ System With an Established Comparator Overnight in the Home Setting for Incontinence in Adult Males
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Urinary Incontinence
Keywords: PureWick Urine Collection System
male external catheter
urinary incontinence
urine management
nocturia
nocturnal enuresis
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
Collaborators: name: Becton, Dickinson and Company
First posted: 2025-02-27
Enrollment: 15
Sex: MALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This post-market study will assess the performance of and user satisfaction with the PureWick™ Male External Catheter in a home setting. The study will also observe safety of the study device and collect information from participants about their experience using the device.

Detailed description: Approximately 15 men requiring the use of diapers or pads at night for urine management will take part in this prospective, open-label, crossover trial. Participants will be 1:1 randomized to a treatment sequence using two devices: the PureWick™ System (PureWick™ Male External Catheter \& PureWick™ Urine Collection System) and the UltraFlex™ Self-Adhering Male External Catheter. Participants will use each urine management device overnight while sleeping for a period of 7 days with a 2-day washout period in between. Total duration of participation is approximately 16 days. The primary efficacy endpoint is the mean capture rate. The primary safety endpoint is the number of device-related AEs requiring medical intervention. Capture rates and Adverse Events are assessed daily throughout each 7-day treatment phase. Sleep disturbance is assessed at baseline and every 7 days during treatment. End of study preference questionnaire is completed at the end of treatment. Device adherence is assessed by the proportion of device wear nights that the study device became dislodged. Tolerability is assessed by number of nights of actual device use.

Eligibility criteria: Inclusion Criteria:

1. Adult male participants ≥ 65 years of age at the time of signing the informed consent
2. Male anatomy at the time of enrollment
3. Currently use diapers, pads, or equivalent at night for urine output management
4. Willing to comply with all study procedures in this protocol
5. Provision of signed and dated informed consent form

Exclusion Criteria:

1. Has frequent episodes of bowel incontinence; or
2. Has chronic urinogenital infections, active genital herpes; or
3. Has Urinary retention; or
4. Has experience using study devices in the home setting within the last year; or
5. Is agitated, combative, and/or uncooperative and may remove the external catheter; or
6. Has any wound, open lesion or irritation on the genitalia, perineum, or sacrum; or
7. Any other condition that, in the opinion of the investigator, would preclude them from participating in the study; or
8. Is considered a vulnerable population.

Primary outcomes:
measure: Performance of the PureWick MEC in the Home Setting
timeFrame: Daily for 7 days during each treatment phase
measure: Number of device-related Adverse events requiring medical intervention
timeFrame: Daily for 7 days during each treatment phase
Secondary outcomes:
measure: Participant Device Preference
timeFrame: After completion of both 7-day treatment phase or at the time of treatment discontinuation, whichever comes first.
measure: Participant Device Tolerance
timeFrame: After completion of each 7-day treatment phase or at the time of treatment discontinuation, whichever comes first.
measure: Device Adherence/Dislodgement
timeFrame: After completion of each 7-day treatment phase or at the time of treatment discontinuation, whichever comes first.
Other outcomes:
measure: Participant Sleep Quality
timeFrame: Starting at baseline and then after completion of each 7 day treatment phase.
Locations:
city: Greenacres City
country: United States
facility: Finlay Medical Research
state: Florida
city: Hamilton
country: United States
facility: Trialfinity Clinical Research Center
state: New Jersey
Study officials:
References: