This Study Will Collect Clinical and Patient Reported Experience Data From Participants Requiring Urine Output Management Overnight in the Home Setting. (PUREST)

July 22, 2025 updated by: C. R. Bard

A Randomized, Controlled Trial on the Safety, Efficacy, and Patient Reported Experience Comparing PureWick™ System With an Established Comparator Overnight in the Home Setting (PUREST)

This post-market study will assess the performance of and user experience with the PureWick™ System in a home setting. The study will also observe safety of the study device and collect information from participants about their quality of life before and after using the device.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Approximately 150 women with nighttime urinary incontinence will take part in this prospective, open-label, randomized trial. Participants will use one of two different study devices during the study to manage urine output at night: PureWick™ System or the Hollister® Female Urinary Pouch External Collection Device. Participant device assignment will be random. Participants will use the assigned urine management device overnight while sleeping and will be followed for approximately 4 weeks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
171

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Guntersville, Alabama, United States, 35976
        • Lakeview Clinical Research
    • Arizona
      • Chandler, Arizona, United States, 85224
        • New Horizons Clinical Trials
    • California
      • Eagle Rock, California, United States, 90041
        • The Practice of Medicine INC.
    • Florida
      • Greenacres City, Florida, United States, 33467
        • Finlay Medical Research
      • Miami, Florida, United States, 33126
        • Finlay Medical Research
    • Georgia
      • Dunwoody, Georgia, United States, 30338
        • Smith Medical Center
      • Riverdale, Georgia, United States, 30274
        • Sonar Clinical Research
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Leavitt Clinical Research
    • Kentucky
      • Owensboro, Kentucky, United States, 42303
        • Research Integrity
    • Michigan
      • Dearborn Heights, Michigan, United States, 48127
        • Revive Research Institute
    • New Jersey
      • Hamilton, New Jersey, United States, 08619
        • Trialfinity Clinical Research Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Clinical Trials
    • New York
      • Bronx, New York, United States, 10456
        • Prime Global Research
    • Tennessee
      • Johnson City, Tennessee, United States, 37604
        • MultiSpecialty Clinical Research
    • Texas
      • Houston, Texas, United States, 77008
        • Trio Clinical Trials

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adult Female Participants greater than or equal to 18 years of age at the time of signing the informed consent.
  2. Currently use diapers or equivalent at night for urine output management.
  3. Willing to comply with all study procedures in this CIP.
  4. Provision of signed and dated informed consent form.

Exclusion Criteria:

  1. Has frequent episodes of bowel incontinence without a fecal management system in place; or
  2. Has moderate to heavy menstruation and cannot use a tampon or menstrual cup; or
  3. Has urinary tract, vaginal or other chronic infections, active genital herpes; or
  4. Has urinary retention; or
  5. Is agitated, combative, and/or uncooperative and may remove the external catheter or pouch; or
  6. Has any wound, open lesion or irritation on the genitalia, perineum, or sacrum; or
  7. Has any pre-existing neurological, psychiatric, or other condition that would confound quality of life assessment or would make it difficult to self-report on quality-of-life questionnaires in the opinion of the investigator; or
  8. Is known to be pregnant at time of enrollment (for women of childbearing age); or
  9. Any other condition that, in the opinion of the investigator, would preclude them from participating in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Hollister
Device: Hollister Female Urinary Pouch External Collection Device
The Hollister Female Urinary Pouch External Collection Device is intended to collect and contain urine for individuals with urinary incontinence.
Experimental: PureWick
Device: PureWick System
The PureWick System consists of the PureWick Urine Collection System used with the PureWick Flex Female External Catheter, which are intended for non-invasive urine output management.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Performance of the PureWick System in the home setting
Time Frame: From enrollment to the end of treatment at 4 weeks
Daily capture rate (captured as % of urine captured by device and collected in canister, measured by weight)
From enrollment to the end of treatment at 4 weeks
Safety of the PureWick System in the home setting
Time Frame: From enrollment to the end of treatment at 4 weeks
Daily skin irritation score using the 5-point Draize dermal irritation scoring system ranging from 0 to 4 with higher scores indicating greater irritation.
From enrollment to the end of treatment at 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Participant Device Tolerance
Time Frame: From enrollment to the end of treatment at 4 weeks
Number of days of actual device use over the expected treatment duration.
From enrollment to the end of treatment at 4 weeks
Participant Device Experience - Comfort
Time Frame: From enrollment to the end of treatment at 4 weeks
Overall comfort on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome.
From enrollment to the end of treatment at 4 weeks
Participant Device Experience - Ease of Use
Time Frame: From enrollment to the end of treatment at 4 weeks
Overall ease of use on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome.
From enrollment to the end of treatment at 4 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nocturnal Incontinence related Quality of Life
Time Frame: From enrollment to the end of treatment at 4 weeks
Nocturia Quality of Life (N-QOL) score collected at baseline and every 2 weeks during treatment with higher scores indicating better QoL. The NQoL contains 12 scored items each scored from 0 to 4. All item scores are computed into a total score ranging from 0-100 where 0 is the worst QoL and 100 is the best QoL.
From enrollment to the end of treatment at 4 weeks
Participant Sleep Quality
Time Frame: From enrollment to the end of treatment at 4 weeks

PROMIS Sleep Disturbance Short Form 4a score collected at baseline and every 7 days during treatment with higher scores indicating greater sleep disturbance.

The PROMIS Sleep Disturbance 4a contains 4 scored items each scored from 1 to 5. All item raw scores are computed into a total score where higher scores indicate a worse outcome.
From enrollment to the end of treatment at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
C. R. Bard

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Becton, Dickinson and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UCC-23HC009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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