Continence (Sep 2023)
Outpatient PureWick™ female external catheter system performance: Healthy volunteer study
Abstract
Objectives:: The PureWick™ female external catheter provides a non-invasive method to manage female urinary incontinence, measure urinary output, and reduce skin breakdown from urinary incontinence. This study seeks to expand the limited clinical evidence of the PureWick™ System in a non-acute setting by evaluating the efficacy of self-placement compared with healthcare provider placement, comfort, and ease of use in the outpatient community setting. If the performance of the PureWick™ System is comparable to healthcare provider placement when used in a non-acute setting and placed by the participant, further research is needed to understand the benefits and risks of medical use of the PureWick™ System used in the home when absent from supervised medical care. Study Design:: Prospective, single-center, non-randomized quasi-experimental healthy volunteer study. Methods:: 71 healthy, female volunteers were divided into cohorts based on body mass index (BMI) and performed two supervised, independent, supine voids. The first void was into a PureWick™ System placed by a healthcare provider followed by a void with independent participant placement after viewing of an instructional video. Outcome parameters included percent of void captured, comfort, and ease of use using a 5-point Likert scale. Adverse events were also collected. Descriptive analyses were conducted for all study variables. Results:: Median capture rate was over 95% for healthcare provider-placed devices and over 98% for self-placed devices, regardless of BMI. Overall, 84.5% of participants rated the device as either “comfortable” or “very comfortable”. Device placement was rated “very easy” by 95.7% of healthcare providers and “very easy” or “somewhat easy” by 95.7% of participants. Device removal was rated “very easy” by 100% of healthcare providers and over 90% of participants in all cohorts. Conclusions:: Healthy volunteers found the PureWick™ comfortable and easy to use for self-placement. The comparable performance of the PureWick™ System, when used in a non-acute setting and placed by the participant, may help to expand the limited clinical evidence of the PureWick™ System in a non-acute setting.
