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Completed

NCT Number: NCT06666426

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

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.

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Key information

Conditions

Adult Nocturnal Enuresis Behavior Behavioral Symptoms Elimination Disorders Enuresis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Mental Disorders Nervous System Diseases Nocturnal Enuresis Parasomnias Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders Urinary Incontinence Urinary Incontinence (UI) Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Lakeview Clinical Research, Guntersville, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Has frequent episodes of bowel incontinence without a fecal management system in place; or
  • Has moderate to heavy menstruation and cannot use a tampon or menstrual cup; or
  • Has urinary tract, vaginal or other chronic infections, active genital herpes; or
  • Has urinary retention; or
  • Is agitated, combative, and/or uncooperative and may remove the external catheter or pouch; or
  • Has any wound, open lesion or irritation on the genitalia, perineum, or sacrum; or
  • 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
  • Is known to be pregnant at time of enrollment (for women of childbearing age); or
  • Any other condition that, in the opinion of the investigator, would preclude them from participating in the study.

Treatment and study plan

PureWick System

Device

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.

Hollister Female Urinary Pouch External Collection Device

Device

The Hollister Female Urinary Pouch External Collection Device is intended to collect and contain urine for individuals with urinary incontinence.

Primary outcomes

  1. 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)

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

C. R. Bard

Industry

Collaborators

  • Becton, Dickinson and Company

Registry information

Official study title

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)

Acronym: PUREST

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 30, 2024
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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