A Pilot Study to Evaluate PureWick for Nocturia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-16

Study Completion Date

2025-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nocturia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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The PureWick Urine Collection System

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.

Group Type EXPERIMENTAL

PureWick System

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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PureWick Urine Collection System device PWF030F

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes