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NCT05508165 · ClinicalTrials.gov registry record · NA
Patient Satisfaction of Virtual vs In-Person Workup and Treatment of Lower Urinary Tract Symptoms.
A NA study of Urologic Diseases, sponsored by Indiana University.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT05508165: Recruiting NA study of Urologic Diseases, sponsored by Indiana University.
NCT05508165 is a NA study of Urologic Diseases that is actively recruiting participants, run by Indiana University. The registered enrollment target is 60 participants, below the 115-participant average among 11 other Urologic Diseases trials with a reported enrollment target (48% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05508165, a NA study of Urologic Diseases, is actively recruiting participants, sponsored by Indiana University.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is being done to compare usefulness of data collected in uroflowmetry, a test that measures the amount of urine released from the body, at home versus in the doctor's office. Additionally, investigators are assessing patient satisfaction when completing a virtual visit for lower urinary tract symptoms (LUTS), related to prostatic enlargement, compared to an in person visit. The three devices being investigated have not been used in the home setting to make urinary measurements as is typically done in clinic. The goal is to test the effectiveness and accuracy of these devices compared to our standard clinical practices and demonstrate their ability to provide useful information in the home setting.
Primary Outcome
The IPSS assesses prostate related symptoms and their frequency of occurrence through seven questions, scored on a 6 point scale, from 0 (not at all) to 5 (always). Total symptom-related scores range from 1-7 (mild), 8-19 (moderate), and 20-35 (severe). The IPSS also assess quality of life due to urinary symptoms with a single question, scored on a 7 point scale (0 = delighted; 6 = terrible). The IPSS will be administered at the initial visit (baseline) for Cohorts 1a and 1b. Baseline scores wi
Conditions Studied
Interventions
- DEVICE Stream Dx
- DEVICE DFree
- DEVICE TestCard
Study Locations (1)
Indiana
- Indiana University - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-08-30 |
| Est. Completion | 2026-12-30 |
| Phase | NA |
What NCT05508165 shows while recruiting
NCT05508165 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 115-participant average among 11 other Urologic Diseases trials with a reported enrollment target (48% lower).
The record links to 1 condition, with Urologic Diseases appearing as the primary indexed condition, and to 3 interventions - of which Stream Dx is the first listed.
NCT05508165 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT05508165 about?
NCT05508165 is a clinical study titled "Patient Satisfaction of Virtual vs In-Person Workup and Treatment of Lower Urinary Tract Symptoms.". This study is being done to compare usefulness of data collected in uroflowmetry, a test that measures the amount of urine released from the body, at home versus in the doctor's office. Additionally, investigators are assessing patient satisfaction when completing a virtual visit for lower urinary t...
What is the current status of trial NCT05508165?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2022-08-30. Estimated completion is 2026-12-30.
What conditions does trial NCT05508165 study?
This clinical trial studies the following conditions: Urologic Diseases.
What interventions are being tested in trial NCT05508165?
The interventions under investigation include: Stream Dx (DEVICE), DFree (DEVICE), TestCard (DEVICE).
Who is sponsoring clinical trial NCT05508165?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05508165 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05508165's enrollment target sits among peer trials
60 7th of 11 higher than 5 of 11 other Urologic Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urologic Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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