Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • PureWick System

    Device

    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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: The PureWick Urine Collection SystemExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The proportion of patients at 3 months who have a demonstrated 50% or greater reduction in the number of nocturia episodes/night

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.

Time frame
3 months
2

Change in average number of nocturnal voids at baseline and at 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.

Time frame
At baseline and 3 months
3

Change of scores on the N-QoL at baseline and at 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.

Time frame
At baseline and 3 months

Secondary outcomes

1

Change in the incidence of urinary tract infection (UTI) at baseline and 3 months

McNemar's chi-square test will be used to compare the incidence of UTI between baseline and at 3 months.

Time frame
At baseline and 3 months
2

Change in the incidence of pressure ulcers/skin breakdown at baseline and 3 months

McNemar's chi-square test will be used to compare pressure ulcers/skin breakdown between baseline and at 3 months.

Time frame
At baseline and 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwell Health

Lead sponsor

Becton, Dickinson and Company

Collaborator

Source ClinicalTrials.gov
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