Safety, Efficacy, and Patient-Reported Outcomes of the PureWick™ System Versus Comparator for Nocturnal Urinary...

Background/Objectives: Urinary incontinence (UI) is highly prevalent among women and substantially impacts quality of life (QoL). However, there remains an unmet need for non-invasive, easy-to-use urine output management options. This study aimed to evaluate the safety, efficacy, and patient-reported outcomes of a suction-assisted female external wicking catheter system (the PureWick System) compared to a well-established comparator-the Hollister Female Urinary Pouch-for nocturnal UI in the home setting. Methods: In total, 165 women (mean age 71.1 years) requiring urine output management at night were randomized 2:1 to use either PureWick (n = 107) or Hollister (n = 58) each night for four weeks. Primary endpoints were urine capture rate and skin irritation (Draize Scale). Secondary endpoints assessed tolerability, comfort, and ease of use. Exploratory endpoints evaluated QoL (Nocturia-QoL questionnaire) and sleep quality (PROMIS Sleep Disturbance). The trial was designed and powered for non-inferiority; superiority analyses were exploratory [ClinicalTrials.gov: NCT06666426]. Results: PureWick met the non-inferiority criteria for both primary endpoints (p < 0.0001). Average urine capture rates were similar between PureWick and Hollister (mean: 90.9% vs. 87.9%; median: 95.4% vs. 97.3%), and mean Draize Scale scores were low for both devices (0.02 vs. 0.16). Participants tolerated PureWick for the same duration as Hollister and rated it more comfortable and easier to use. Both devices improved QoL and sleep quality. Conclusions: PureWick offers a safe, effective, and patient-friendly option for independently managing nocturnal UI in the home setting. Compared with an established alternative, it achieved non-inferiority for primary efficacy and safety endpoints while offering greater comfort and ease of use.