An Observational Study of the PureWick™ System in Women with Urinary Incontinence at Home and in the Care/Nursing Home Setting

Abstract

BACKGROUND: The PureWick™ System (PureWick) is intended for non-invasive urine output management in female patients. PureWick is comprised of the PureWick™ Female External Catheter and the PureWick™ Urine Collection System. OBJECTIVES: The objectives were: (i) to observe how PureWick impacts caregivers and patients, in the care/nursing home setting and at home, and (ii) to compare PureWick with other urinary incontinence management systems (incontinence pads and Foley catheters). The impact of PureWick on care/nursing home patients was evaluated by comparing the number of incontinence interventions (pad checks, pad changes, other observations such as bed pan/bed linen/clothing change or wash) when using PureWick compared with pads or Foley catheters. Care/nursing home and home users provided Patient-Reported Outcomes Measurements (PROMs) feedback on user experience of comfort, ease of use, efficacy, impact on daily living and quality of life when using PureWick compared with pads or Foley catheters. The impact of PureWick on carers was evaluated in the PROMs questionnaire by asking how much continence care they had given the user while using PureWick compared with pads. Carers were also given the opportunity to provide any additional comments. STUDY DESIGN, SETTING AND PARTICIPANTS: Staff in care/nursing homes identified female incontinent residents using pads or indwelling Foley catheters who met the eligibility criteria for the study. Participants (25) ranging from 31 to 107 years (mean age 75.7 years) of age enrolled in the observational study: 11 from care/nursing homes and 14 home-based users. MEASUREMENTS: Baseline continence information was collected for 10-14 days, then for 10-14 days using PureWick. Care staff recorded the daily intervention data which was then collated. This was an observational study, and due to the sample size of 25 participants across two different data gathering approaches, statistical analysis methods were not applied. RESULTS:Notably fewer pad-only changes were recorded during the PureWick trial compared with baseline (103 vs 522). Night-time interventions that disturb the patient reduced by 65%, with an 89% reduction in participant-reported disturbance of sleep. 88% of PROMS respondents reported that PureWick kept them dry all or most of the time, and 52% said that PureWick never caused them skin irritation. 56% reported that PureWick never caused them to worry about smell; only 16% said this of pads or catheters. PureWick was rated 7.2/10 for comfort compared to 5.7/10 for either pads or catheters. CONCLUSIONS: PureWick has user-reported benefits (including improved independence, dignity and quality of life) over other continence products for some users. The overall opinion of PureWick was positive compared with pads, with 64% of care/nursing home users choosing to continue using PureWick beyond the trial period, and all home users choosing to continue using PureWick following their trial.