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A Pilot Study to Evaluate PureWick for Nocturia

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Northwell Health

Status

Suspended

Conditions

Nocturia

Treatments

Device: PureWick System

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05090722
21-05023603

Details and patient eligibility

About

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.

Full description

Nocturia is a highly prevalent condition among older adults, significantly affecting the quality of life as well as putting them at an increased risk of falls and fractures. In those 65 and older, accidental falls are identified as the leading cause of injury and death. The chance of falling increases from 30% to 50% with age greater than 85 years.

A study identified that in 1508 ambulatory men and women, nighttime urination of 2 times at night is associated with increased risk of falls (OR=1.84, 95% CI 1.05-3.22), with significantly higher risks when it increased to 3 or more times at night (OR=2.15, CI 95% -1.04-4.44). Incontinence management that reduces the need to get out of bed will lead to reduced risk of falls and unintentional injury fatalities.

The PureWick Urine Collection System is intended for non-invasive urine output management. It pulls urine through tubing that is connected to a collection canister for proper disposal. It is designed to be used by patients, caregivers, or healthcare professionals in both home environments and professional care facilities.

The PureWick System allows individuals to void while still in bed, demonstrating the potential to reduce the risks of falls associated with nighttime voids in men and women with nocturia. We hypothesize that this will also improve sleep quality and overall quality of life.

Enrollment

40 estimated patients

Sex

Female

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

The PureWick Urine Collection System
Experimental group
Description:
The PureWick Urine Collection System is intended for non-invasive urine output management. It pulls urine through tubing that is connected to a collection canister for proper disposal. It is designed to be used by patients, caregivers, or healthcare professionals in both home environments and professional care facilities.
Treatment:
Device: PureWick System

Trial contacts and locations

1

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Central trial contact

Rabia Bukhari, RN; Sagar Shah, RC

Data sourced from clinicaltrials.gov

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