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Home urine tests may let men skip clinic visits for prostate symptoms

NCT ID NCT05508165

Knowledge-focused Sponsor: Indiana University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This study compares at-home urinary testing devices with standard clinic tests for men who have lower urinary tract symptoms due to an enlarged prostate. Participants either use the devices at home or come to the clinic for the same measurements, including urine flow, bladder emptying, and urine analysis. Researchers also measure patient satisfaction with virtual versus in-person visits. The goal is to see whether home-based testing can provide equally useful information and improve convenience.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
At-home urinary testing devices (Stream Dx uroflowmetry device, DFree wearable bladder scanner, TestCard mobile urinalysis reader) and virtual visits
What this could lead to
If the devices prove accurate and patients are satisfied, men with prostate-related urinary symptoms might complete testing and follow-up from home, reducing clinic visits.
What could go wrong
This is a small early study, and the devices may not match clinic measurements. Virtual visits might not suit everyone, and some men may need in-person exams.

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

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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 * ≥18 years of age * New patient referral for urinary retention, BPH, or LUTS (Cohort 1) * Established patient for urinary retention, BPH, or LUTS (Cohort 2) * Male Exclusion Criteria * \<18 years of age * Inability to provide informed consent * Visually or hearing impaired * Concomitant condition requiring in-person exam or evaluation * History of allergic reaction or issues with ultrasound gel

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Conditions

The condition(s) this trial relates to.

urinary system disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Urologic diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. 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

  • Indiana University

    Indianapolis, Indiana, 46202, United States

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