Recruiting

PureWick

Sponsor:

Northwell Health

Code:

NCT05090722

Conditions

Nocturia

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Accepted

Interventions

PureWick System

Study Details

Brief summary:

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.

Conditions

Nocturia

Study ID

NCT05090722

Start date

Dec 16, 2021

Status verified date

Jun, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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.

Primary outcome measure

  • The proportion of patients at 3 months who have a demonstrated 50% or greater reduction in the number of nocturia episodes/night [ Time Frame: 3 months ]
  • Change in average number of nocturnal voids at baseline and at 3 months [ Time Frame: At baseline and 3 months ]
  • Change of scores on the N-QoL at baseline and at 3-months [ Time Frame: At baseline and 3 months ]

Central Contacts and Locations

Central contacts

Bilal Chughtai, MD

516-628-5910bchughtai@northwell.edu

Jennifer Polo, CCRC

516-628-5910Jpolo1@northwell.edu

Locations

Multi-Specialty NHPP Syosset

Recruiting

Syosset, New York, United States, 11791

Contacts

Bilal Chughtai, MD

516-628-5910Bchughtai@northwell.edu

Jennifer Polo, CCRC

Jpolo1@northwell.edu

More Information

Sponsor

Northwell Health

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2026-06-15.