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NCT05090722

A Pilot Study to Evaluate PureWick for Nocturia

Recruiting
NAAges 50+InterventionalTreatment
Northwell Health
~40 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:PureWick System

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The proportion of patients at 3 months who have a demonstrated 50% or greater reduction in the number of nocturia episodes/night
Measured over 3 months
+2 more outcomes measured

Conditions

Nocturia

Explore related trials

Nocturia

Where it's being run

2 sites across 1 states
New York2

Study leadership

  • Bilal Chughtai, MD · PRINCIPAL_INVESTIGATOR · Northwell Health

Who to contact

Bilal Chughtai, MD
[email protected]
516-628-5910
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Eligibility criteria

Inclusion

Women aged 50 years or older.
Experiences 2 or more voids per night as assessed on a 3-day bladder diary.

Exclusion

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.

What this trial measures

  • The proportion of patients at 3 months who have a demonstrated 50% or greater reduction in the number of nocturia episodes/night3 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 monthsAt 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-monthsAt 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.