A Pilot Study to Evaluate PureWick for Nocturia
ConditionNocturia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50+
SponsorNorthwell Health
About this trial
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 criteria
Qualifiers
Women aged 50 years or older.
Experiences 2 or more voids per night as assessed on a 3-day bladder diary.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- PureWick System
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Northwell Health
Lead sponsor
Becton, Dickinson and Company
Collaborator
Source ClinicalTrials.gov