A Pilot Study to Evaluate PureWick for Nocturia

NCT05090722 | Suspended FDA Device

• 1 other identifier: 21-05023603
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• The proportion of patients at 3 months who have a demonstrated 50% or greater reduction in the number of nocturia episodes/night

  The proportion of patients at 3 months who have a demonstrated 50% or greater reduction in the number of nocturia episodes/night will be calculated via binomial proportions and an exact (Clopper-Pearson) 95% confidence interval will be computed to assess the precision of the obtained estimate.

  3 months

• Change in average number of nocturnal voids at baseline and at 3 months

  The paired t-test or Wilcoxon signed-rank test will be used, as appropriate, to compare the average number of nocturnal voids between baseline and at 3 months.

  At baseline and 3 months

• Change of scores on the N-QoL at baseline and at 3-months

  N-QoL (Nocturia quality of life) score is determined by the n-qol short form. The ICIQ-Nqol is a patient-completed questionnaire evaluating quality of life (QoL) in patients with nocturia for use in research and clinical practice across the world. The ICIQ-Nqol is the N-QoL adapted for use within the ICIQ structure and provides a detailed and robust measure to assess the impact of nocturia on quality of life with particular reference to the effects on patient' lives of Nocturia and can be used as an outcome measure to assess impact of different treatment modalities. 0-52 overall score with greater values indicating increased impact on quality of life Bother scale not incorporated into overall score but indicate impact of symptoms overall for the patient. Similar analyses to paired t-test or Wilcoxon signed-rank test will be performed to compare scores on the N-QoL, an self-reported sleep quality between baseline and at 3-months.

  At baseline and 3 months

Secondary Outcomes (2)

• Change in the incidence of urinary tract infection (UTI) at baseline and 3 months

  At baseline and 3 months

• Change in the incidence of pressure ulcers/skin breakdown at baseline and 3 months

  At baseline and 3 months

Study Arms (1)

The PureWick Urine Collection System

EXPERIMENTAL

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.

Device: PureWick System

Interventions

PureWick System DEVICE

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.

Also known as: PureWick Urine Collection System device, PWF030F

The PureWick Urine Collection System

Eligibility Criteria

• Age: 50 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 50 years or older.
• Experiences 2 or more voids per night as assessed on a 3-day bladder diary.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwell Health: lead
• Becton, Dickinson and Company: collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Related Publications (5)

• Chiarelli PE, Mackenzie LA, Osmotherly PG. Urinary incontinence is associated with an increase in falls: a systematic review. Aust J Physiother. 2009;55(2):89-95. doi: 10.1016/s0004-9514(09)70038-8.

  PMID: 19463079 BACKGROUND

• Centers for Disease Control and Prevention, N.C.f.I.P.a.C. Web-based Injury Statistics Query and Reporting System (WISQARS). December 7, 2014].

  BACKGROUND

• Medical Advisory Secretariat. Prevention of falls and fall-related injuries in community-dwelling seniors: an evidence-based analysis. Ont Health Technol Assess Ser. 2008;8(2):1-78. Epub 2008 Oct 1.

  PMID: 23074507 BACKGROUND

• Hunter KF, Voaklander D, Hsu ZY, Moore KN. Lower urinary tract symptoms and falls risk among older women receiving home support: a prospective cohort study. BMC Geriatr. 2013 May 15;13:46. doi: 10.1186/1471-2318-13-46.

  PMID: 23672343 BACKGROUND

• Beeson T, Davis C. Urinary Management With an External Female Collection Device. J Wound Ostomy Continence Nurs. 2018 Mar/Apr;45(2):187-189. doi: 10.1097/WON.0000000000000417.

  PMID: 29394218 BACKGROUND

MeSH Terms

Conditions

Nocturia

Condition Hierarchy (Ancestors)

Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bilal Chughtai, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 25, 2021
• Study Start: December 16, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)