Could a simple catheter cut nighttime bathroom trips and falls?
NCT ID NCT05090722
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study is testing whether the PureWick, an external urine collection device, can help women aged 50 and older who wake up to urinate at least twice a night. The goal is to see if using the device reduces the number of nighttime bathroom visits and lowers the risk of falls. Forty women will use the device and be followed for three months to track changes in urination, sleep quality, and any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PureWick external urine collection device
- What this could lead to
- If successful, this device could offer a non-invasive way to reduce nighttime urination and prevent falls in older women.
- What could go wrong
- This is a small pilot study with only 40 participants and no comparison group. The device may not work for everyone, and there is a risk of skin irritation or urinary tract infections.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2021
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 years and older
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Multi-Specialty NHPP Syosset
RECRUITINGSyosset, New York, 11791, United States
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Weill Cornell Medicine
COMPLETEDNew York, New York, 10065, United States
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- Could acupuncture with a jolt ease bladder urgency?
- New wearable gadget aims to curb nighttime bathroom runs
- Ancient moxibustion therapy tested for nocturia relief