Pilot Study of the PureWick System to Reduce Nighttime Bathroom Trips and Falls in Women with Nocturia Aged 50 and Older

What this Trial Is About

This research evaluates the PureWick Urine Collection System as a non-invasive way to manage nocturia in women aged 50 and older. Nocturia, which involves waking at night to urinate, is common in older adults and increases the risk of falls and fractures. The study aims to assess whether using PureWick can reduce nighttime bathroom trips and improve sleep quality and overall life quality. Participants use the PureWick System, which includes an external catheter, tubing, and a collection canister. The device allows urine collection while remaining in bed, potentially lowering fall risk. The study is a single-group pilot conducted at one center, with follow-up lasting up to 3 months to observe urinary and sleep outcomes, as well as any related adverse events. During the study, participants are monitored for changes in the number of nocturia episodes, sleep quality via questionnaires, and other health factors such as urinary tract infections and skin condition. Data is collected at the start and after 3 months of device use. Researchers will measure how many patients achieve a 50% or greater reduction in nighttime urination, along with quality-of-life improvements and safety outcomes.

A Pilot Study to Evaluate PureWick for Nocturia