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NocturiaNCT05090722

A Pilot Study to Evaluate PureWick for Nocturia

A study testing PureWick System in people with Nocturia, run by Northwell Health at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Nocturia
What is being tested?
PureWick System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesUnited States
Study dates
16 Dec 2021to Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Bilal Chughtai, MD contact

516-628-5910

bchughtai@northwell.edu

Jennifer Polo, CCRC contact

516-628-5910

Jpolo1@northwell.edu

United States2 sites, 1 recruiting

  • Weill Cornell Medicine

    New York, New York, 10065

    Completed

  • Multi-Specialty NHPP Syosset

    Syosset, New York, 11791

    Bilal Chughtai, MD, 516-628-5910, Bchughtai@northwell.edu

    Jennifer Polo, CCRC, Jpolo1@northwell.edu

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

Nocturia is a highly prevalent condition among older adults, significantly affecting the quality of life as well as putting them at an increased risk of falls and fractures. In those 65 and older, accidental falls are identified as the leading cause of injury and death. The chance of falling increases from 30% to 50% with age greater than 85 years.

A study identified that in 1508 ambulatory men and women, nighttime urination of 2 times at night is associated with increased risk of falls (OR=1.84, 95% CI 1.05-3.22), with significantly higher risks when it increased to 3 or more times at night (OR=2.15, CI 95% -1.04-4.44). Incontinence management that reduces the need to get out of bed will lead to reduced risk of falls and unintentional injury fatalities.

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.

The PureWick System allows individuals to void while still in bed, demonstrating the potential to reduce the risks of falls associated with nighttime voids in men and women with nocturia. We hypothesize that this will also improve sleep quality and overall quality of life.

Conditions
Nocturia
Being tested
PureWick System
Medical subject headings
Nocturia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PureWick SystemDevice

    Also called PureWick Urine Collection System device, PWF030F

    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.

Study groups in NCT05090722
Study groupRoleWhat they receive
The PureWick Urine Collection SystemExperimentalThe 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.
Receives: Device: PureWick System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months

  2. 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.

    Measured: At baseline and 3 months

  3. 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.

    Measured: At baseline and 3 months

Secondary outcomes (2)

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

    McNemar's chi-square test will be used to compare the incidence of UTI between baseline and at 3 months.

    Measured: At baseline and 3 months

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

    McNemar's chi-square test will be used to compare pressure ulcers/skin breakdown between baseline and at 3 months.

    Measured: At baseline and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2021
  2. Study start16 Dec 2021
  3. Primary completionOct 2027 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05090722
Sponsor's protocol ID
21-05023603
Status last verified
Jun 2026
First submitted
12 Oct 2021
Last updated
15 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 19463079

  • 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].

  • 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.

    PubMed 23074507

  • 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.

    PubMed 23672343

  • 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.

    PubMed 29394218

Questions about this trial

What is this clinical trial studying?

A study testing PureWick System in people with Nocturia, run by Northwell Health at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bilal Chughtai, MD (516-628-5910, bchughtai@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05090722, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.

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