NCT05090722 · Northwell Health
A Pilot Study to Evaluate PureWick for Nocturia
What this study is about
This is a single-center forward-looking 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.
View original scientific description
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.
Interventions
DEVICE
PureWick 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.
Primary outcome measures
The proportion of patients at 3 months who have a demonstrated 50% or greater reduction in the number of nocturia episodes/night
Time frame: 3 months
The proportion of patients at 3 months who have a demonstrated 50% or greater reduction in the number of nocturia episodes/night will be calculated via binomial proportions and an exact (Clopper-Pearson) 95% confidence interval will be computed to assess the precision of the obtained estimate.
Change in average number of nocturnal voids at baseline and at 3 months
Time frame: At baseline and 3 months
The paired t-test or Wilcoxon signed-rank test will be used, as appropriate, to compare the average number of nocturnal voids between baseline and at 3 months.
Change of scores on the N-QoL at baseline and at 3-months
Time frame: At baseline and 3 months
N-QoL (Nocturia quality of life) score is determined by the n-qol short form. The ICIQ-Nqol is a patient-completed questionnaire evaluating quality of life (QoL) in patients with nocturia for use in research and clinical practice across the world. The ICIQ-Nqol is the N-QoL adapted for use within the ICIQ structure and provides a detailed and robust measure to assess the impact of nocturia on quality of life with particular reference to the effects on patient' lives of Nocturia and can be used as an outcome measure to assess impact of different treatment modalities. 0-52 overall score with greater values indicating increased impact on quality of life Bother scale not incorporated into overall score but indicate impact of symptoms overall for the patient. Similar analyses to paired t-test or Wilcoxon signed-rank test will be performed to compare scores on the N-QoL, an self-reported sleep quality between baseline and at 3-months.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- New York, New York
- Syosset, New York
Collaborators
Becton, Dickinson and Company
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 15, 2026 · Source of record for eligibility and locations