A Pilot Study to Evaluate PureWick for Nocturia
Northwell Health
40 participants
Dec 16, 2021
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- Women aged 50 years or older.
- Experiences 2 or more voids per night as assessed on a 3-day bladder diary.
Exclusion Criteria5
- 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.
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Interventions
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)
View Full Details on ClinicalTrials.gov
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NCT05090722