PureWick™ France and U.S. At-Home Pilot Study

Not Applicable

Completed

Conditions: Nocturnal Enuresis

Registration Number: NCT05710718

Lead Sponsor: C. R. Bard

Brief 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.

Detailed Description: 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.

Approximately 30 female participants from 2 sites will be enrolled into the study. Those meeting eligibility criteria will be treated according to the treatment sequence assigned during randomization. Participants will view the standardized training video for the applicable product at the beginning of each treatment phase and have access to the Information for Use document (IFU) to review during each treatment phase. The total expected duration of subject participation is approximately 10 weeks. Participants will use the device assigned in treatment phase 1 overnight while sleeping for 4 weeks (28 days) before transitioning to the second assigned device in treatment phase 2. There will be a minimum washout period of 2 weeks (not to exceed 4 weeks) between treatment phases and a re-screening of eligibility criteria before the second phase. In both treatment phases, participants will independently place and remove the FEC (female external catheter) or FUP (Female Urinary Pouch) after standardized teaching is completed on the first day of the treatment phase.

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. Health Care Providers (HCPs) will visit participants' homes daily to perform a skin assessment and collect urine measurements during the treatment phases. Participants will be withdrawn from the treatment phase if grade 4 is achieved in any category on the Draize skin irritation scale.

The secondary objectives are to assess quality of life, tolerability, comfort and ease of use. Quality of life and comfort and ease of use will be measured using self-reported changes in quality of life via the validated Nocturia Quality of Life (N-Qol) tool \& the PROMIS Sleep Disturbance Short-form 4a survey, and subjective evaluation of the therapy via participant survey, respectively. Tolerability will be measured by number of days of actual use of both devices, and discontinuation rate attributed to the device's discomfort or inconvenience.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 17

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Daily Average Urine Capture Rate (Percentage)	Daily for 28 days during each treatment phase	Capture rate following void (captured as % of urine captured by device and collected in canister, measured by weight). Prior to each nightly use, the weight of the empty urine collection canister and the weight of a dry absorbent pad are collected. Participants use the device overnight while sleeping with the absorbent pad underneath them. The next morning, the post-void weight of the urine collection canister and the post-void weight of the absorbent pad are collected. Capture rate is calculated as the weight of captured urine (post-void canister weight - pre-void canister weight) / total urine volume (captured urine (post-void canister weight - pre-void canister weight) + leaked urine (post-void pad weight - pre-void pad weight)) \* 100. The primary efficacy endpoint of urine capture rate is derived by computing the mean of daily capture rate during each study phase.
Daily Average Skin Irritation Score Using the Draize Scale	Daily for 28 days during each treatment phase	Draize Scale is a 5 point scale where 0 is no erythema, edema, or bleeding and 4 is severe erythema, edema, and/or bleeding. The primary safety endpoint of skin irritation score is derived by computing the mean of Draize Scale scores assessed daily during each study phase.

Secondary Outcome Measures

Name	Time	Method
Nocturia Quality of Life (N-QOL) Score	Starting at baseline and then every 2 weeks during each treatment phase	N-QOL is a standardized tool used to explore 13 items that might be affected by nocturia (e.g., concentration, productiveness, and low energy). Transformed Total Score is computed from the core 12 item summary scores and ranges from 0-100 with higher scores indicating better quality of life.
Participant's Opinion of Ease of Device Use	After completion of each 28-day treatment phase or at the time of treatment discontinuation, whichever comes first.	Ease of use score on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome, where 1 = Very Difficult, 2 = Somewhat Difficult, 3 = Average Difficulty, 4 = Somewhat Easy, and 5 = Very Easy. The last question related to dryness experienced with the device during sleep ranged from 1-4 with higher scores indicating a better outcome, where 1 = Never Dry, 2 = Sometimes Dry, 3 = Usually Dry, 4 = Always dry to mostly always dry
PROMIS Sleep Disturbance - Short Form 4a Score	Starting at baseline and then every 7 days during each treatment phase	The PROMIS Sleep Disturbance Short Form 4a consists of 4 questions that each have 5 response options, with 1 indicating the least sleep disturbance and 5 indicating the most sleep disturbance. Total raw scores are translated into a T-score ranging from 32.0 to 73.3, with higher scores indicating worse outcome.
Participant's Tolerability of Device/Treatment	After completion of the 28-day treatment phase or at the time of treatment discontinuation, whichever comes first.	Participant's tolerability is determined by the number of days of actual device use.
Participant's Comfort Level Associated With Device/Treatment	After completion of each 28-day treatment phase or at the time of treatment discontinuation, whichever comes first.	Overall comfort on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome, where 1 = Very Uncomfortable, 2 = Uncomfortable, 3 = Neither Comfortable nor Uncomfortable, 4 = Comfortable, and 5 = Very Comfortable. The last question related to likelihood to recommend the device ranged from 1-5 with higher scores indicating a better outcome, where 1 = Very Unlikely, 2 = Unlikely, 3 = Neither Likely nor Unlikely, 4 = Likely, and 5 = Very Likely.

Trial Locations

Locations (2): Smiths Medical Center
🇺🇸
Dunwoody, Georgia, United States
Weill Cornell Medical Center
🇺🇸
New York, New York, United States
Smiths Medical Center
🇺🇸Dunwoody, Georgia, United States