CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 171 enrolled
Drug / intervention
PureWick System +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06666426
NCT06666426N/ACompleted
CompareCT.gov

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)

C. R. Bard·interventional·Posted Oct 30, 2024·Updated Jul 24, 2025

In Brief

A clinical study evaluating PureWick System and Hollister Female Urinary Pouch External Collection Device for Adult Nocturnal Enuresis and Urinary Incontinence (UI). Completed, enrolled 171 participants across 15 sites.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdult Nocturnal Enuresis, Urinary Incontinence (UI)
CountriesUnited States
CollaboratorsBecton, Dickinson and Company

Timeline

N/ACompletedFinished
20252026
First PostedOct 30, 2024
Enrollment StartOct 31, 2024
Primary CompletionJun 30, 2025
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 1.7 years ago

Interventions

PureWick Systemdevice

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 Devicedevice

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