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Butterfly portable ultrasound device with bladder ultrasound images for Urinary Incontinence

N/A
Waitlist Available
Led By Jaime Cavallo, MD, MPHS
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights

Study Summary

This trial shows that the Butterfly portable ultrasound device can accurately and reliably measure post-void residual bladder volume in patients with obstructive voiding dysfunction. The device also has a positive impact on clinical care and patient satisfaction.

Eligible Conditions
  • Urinary Incontinence
  • Urinary Retention

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Accuracy of patient self-measurement of PVR using the Butterfly with bladder ultrasound images compared to the healthcare provider's bladder catheterization of the patient measured by Bland-Altman analysis.
Urinary Bladder
Accuracy of self-measurement of PVR using the Butterfly with bladder ultrasound images compared to the Butterfly with abstract bladder images measured by Bland-Altman analysis.
+2 more
Secondary outcome measures
Patient Reported Outcomes Questionnaire to asses ease of use, satisfaction, and preference of Butterfly Device

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Self PVR measurement using Butterfly and bladder ultrasound imagesExperimental Treatment1 Intervention
The participant will perform self PVR measurement (3 consecutive measurements during the same encounter) using the Butterfly and bladder ultrasound images (prior to catheterization, if needed)
Group II: Self PVR measurement using Butterfly and abstract bladder imagesExperimental Treatment1 Intervention
The participant will perform self PVR measurement (3 consecutive measurements during the same encounter) using the Butterfly and abstract bladder images (prior to catheterization, if needed)
Group III: Healthcare provider performed PVR measurement using Butterfly and bladder ultrasound imagesExperimental Treatment1 Intervention
The Urologic healthcare provider will perform PVR measurement on the participant (3 consecutive measurements during the same encounter) using the Butterfly and bladder ultrasound images
Group IV: Healthcare provider performed PVR measurement using Butterfly and abstract bladder imagesExperimental Treatment1 Intervention
The Urologic healthcare provider will perform PVR measurement on the participant (3 consecutive measurements during the same encounter) using the Butterfly and abstract bladder images
Group V: Healthcare provider performed standard PVR measurement using existing ultrasound technologyActive Control1 Intervention
The Urologic healthcare provider will perform standard point-of-care PVR measurement on the participant (3 consecutive measurements during the same encounter) using existing ultrasound technology
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Butterfly portable ultrasound device with bladder ultrasound images
2022
N/A
~50
Butterfly portable ultrasound device with abstract bladder images
2022
N/A
~50

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,846 Previous Clinical Trials
2,736,429 Total Patients Enrolled
3 Trials studying Urinary Incontinence
296 Patients Enrolled for Urinary Incontinence
Butterfly Network, IncUNKNOWN
Jaime Cavallo, MD, MPHSPrincipal InvestigatorYale University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Patient Self Measurement of Post-Void Residual Bladder Volume (PVR) Using Ultrasound
2022. "Patient Self Measurement of Post-Void Residual Bladder Volume (PVR) Using Ultrasound". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05295823.
~17 spots leftby Apr 2025
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