A Pilot Study to Evaluate PureWick for Nocturia
Northwell Health
Summary
This is a single-center prospective pilot study of PureWick used as a management for nocturia and reduction of nighttime falls associated with going to the bathroom. Subjects are followed up to 3 months after the intervention. As a pilot study, it is expected that a 3-month follow-up will adequately capture urinary and sleep outcomes data and any adverse events related or unrelated to the study device.
Description
Nocturia is a highly prevalent condition among older adults, significantly affecting the quality of life as well as putting them at an increased risk of falls and fractures. In those 65 and older, accidental falls are identified as the leading cause of injury and death. The chance of falling increases from 30% to 50% with age greater than 85 years. A study identified that in 1508 ambulatory men and women, nighttime urination of 2 times at night is associated with increased risk of falls (OR=1.84, 95% CI 1.05-3.22), with significantly higher risks when it increased to 3 or more times at night…
Eligibility
- Age range
- 50+ years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: * Women aged 50 years or older. * Experiences 2 or more voids per night as assessed on a 3-day bladder diary. Exclusion Criteria: * Compromised skin integrity in the perineal area (e.g., ulcers, open wounds, etc.). * Neurological impairment or psychiatric disorder preventing proper understanding of consent. * Unable to operate the PureWick system. * Unable to complete required questionnaires and diaries. * Investigator deems subject as unsuitable for enrollment.
Interventions
- DevicePureWick System
The PureWick system consists of the external catheter, collection tubing, and collection canister with lid. It operates via a power cord that is plugged into the device outlet and the A/C power outlet.
Locations (2)
- Weill Cornell MedicineNew York, New York
- Multi-Specialty NHPP SyossetSyosset, New York