PureWick™ France and U.S. At-Home Pilot Study

NCT05710718 | Completed Results FDA Device

• 1 other identifier: UCC-8007
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

Brief Summary

In this prospective, post-market, multi-site, open-label, crossover trial, women with urinary incontinence requiring the use of diapers (changes complets (French term)) at night will be 1:1 randomized to a treatment sequence using two devices (PureWick™ System and Hollister® Female Urinary Pouch External Collection Device) and followed for approximately 10 weeks through 2 treatment phases. The primary objectives are to evaluate safety (skin injury) and efficacy (capture rate). Safety will be assessed using the Draize Scale and efficacy will be measured based on daily urine capture rate.

Conditions

Nocturnal Enuresis

Outcome Measures

Primary Outcomes (2)

• Daily Average Urine Capture Rate (Percentage)

  Capture rate following void (captured as % of urine captured by device and collected in canister, measured by weight). Prior to each nightly use, the weight of the empty urine collection canister and the weight of a dry absorbent pad are collected. Participants use the device overnight while sleeping with the absorbent pad underneath them. The next morning, the post-void weight of the urine collection canister and the post-void weight of the absorbent pad are collected. Capture rate is calculated as the weight of captured urine (post-void canister weight - pre-void canister weight) / total urine volume (captured urine (post-void canister weight - pre-void canister weight) + leaked urine (post-void pad weight - pre-void pad weight)) \* 100. The primary efficacy endpoint of urine capture rate is derived by computing the mean of daily capture rate during each study phase.

  Daily for 28 days during each treatment phase

• Daily Average Skin Irritation Score Using the Draize Scale

  Draize Scale is a 5 point scale where 0 is no erythema, edema, or bleeding and 4 is severe erythema, edema, and/or bleeding. The primary safety endpoint of skin irritation score is derived by computing the mean of Draize Scale scores assessed daily during each study phase.

  Daily for 28 days during each treatment phase

Secondary Outcomes (5)

• Nocturia Quality of Life (N-QOL) Score

  Starting at baseline and then every 2 weeks during each treatment phase

• PROMIS Sleep Disturbance - Short Form 4a Score

  Starting at baseline and then every 7 days during each treatment phase

• Participant's Tolerability of Device/Treatment

  After completion of the 28-day treatment phase or at the time of treatment discontinuation, whichever comes first.

• Participant's Comfort Level Associated With Device/Treatment

  After completion of each 28-day treatment phase or at the time of treatment discontinuation, whichever comes first.

• Participant's Opinion of Ease of Device Use

  After completion of each 28-day treatment phase or at the time of treatment discontinuation, whichever comes first.

Study Arms (2)

Treatment Sequence 1

OTHER

The PureWick™ System is used for the first 4 weeks, followed by cross-over to the Hollister Female Urinary Pouch.

Device: PureWick™ System; Device: Hollister® Female Urinary Pouch External Collection Device

Treatment Sequence 2

OTHER

The Hollister Female Urinary Pouch is used for the first 4 weeks, followed by cross-over to the PureWick™ System.

Device: PureWick™ System; Device: Hollister® Female Urinary Pouch External Collection Device

Interventions

PureWick™ System DEVICE

The PureWick™ FEC is intended for non-invasive urine output management in female patients. The PureWick™ FEC is a flexible, contoured external catheter that is positioned against the area where urine exits the female body. The PureWick™ FEC is connected to the PureWick™ Urine Collection System (PUCS) via connector tubing. The PUCS uses suction (not felt by the user) to pull voided urine through the device, regardless of the urine flow rate. Urine continues through vinyl tubing until it reaches a collection canister, away from the body.

Treatment Sequence 1; Treatment Sequence 2

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. It is designed to be emptied and should be attached to a drainage bag. The FUP is made with hydrocolloid skin adhesive and polymer/copolymer plastics.

Treatment Sequence 1; Treatment Sequence 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult Female Participants \>18 years of age at the time of signing the informed consent.
• Currently use diapers or equivalent at night for urine capture ("Change complet"(French term))
• Willing to comply with all study procedures in the protocol
• Provision of signed and dated informed consent form

You may not qualify if:

• 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.
• Is under supervision of a legally authorized representative.

Sponsors & Collaborators

• C. R. Bard: lead
• Becton, Dickinson and Company: collaborator

Study Sites (2)

Smiths Medical Center

Dunwoody, Georgia, 30338, United States

Location

Weill Cornell Medical Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Nocturnal Enuresis

Condition Hierarchy (Ancestors)

Enuresis; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Results Point of Contact

• Title: Director Clinical Affairs and Medical Affairs Strategy
• Organization: Becton, Dickinson and Company

Kirsten.Hammitt@bd.com

551-225-1164

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1:1 Crossover

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: February 2, 2023
• Study Start: October 31, 2023
• Primary Completion: August 25, 2024
• Study Completion: August 25, 2024
• Last Updated: July 16, 2025
• Results First Posted: July 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)