Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05295823
Other study ID # 2000031258
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 27, 2022
Est. completion date June 3, 2022

Study information

Verified date March 2023
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study would be the first to demonstrate feasibility, accuracy, reliability, clinical care impact, and patient satisfaction with remote monitoring of post-void residual bladder volume (PVR) using the Butterfly portable ultrasound device in patients with obstructive voiding dysfunction.


Description:

This study would be the first to demonstrate feasibility, accuracy, reliability, and patient satisfaction with self measurement of PVR using the Butterfly portable ultrasound device. In the current study protocol, participants will undergo routine clinical care with no additional clinical encounters for the purposes of this study. As part of routine clinical care, the patient will undergo 3 sequential measurements of patient PVR by the Urologic healthcare provider using the existing ultrasound technology, and a possible bladder catheterization for actual bladder volume measurement and to drain the bladder. Note that 3 sequential measurements are taken from which a mean and standard deviation are derived due to operator and technology-related variability in bladder volume measurement using ultrasound. Participants in the study will also undergo 3 sequential measurements of patient PVR by the Urologic healthcare provider using the Butterfly portable ultrasound device with ultrasound images of the bladder, and 3 sequential measurements of patient PVR by the Urologic healthcare provider using the Butterfly portable ultrasound device with abstract images of the bladder; and the participant will take 3 sequential self-measurements of PVR using the Butterfly portable ultrasound device with ultrasound images of the bladder and 3 sequential self-measurements of PVR using the Butterfly portable ultrasound device with abstract images of the bladder during the same clinic encounter. The Urologic healthcare provider might also perform a bladder catheterization of the patient to determine the actual PVR and to drain the bladder of the residual urine. Ultimately, successful remote measurement of patient PVR may lead to a paradigm shift in how patients with voiding dysfunction are clinically monitored; and would be a critical tool in triaging patients with possible urinary retention at any time but most especially during a pandemic necessitating social distancing and judicious allocation of healthcare resources. Remote PVR measurement in patients with obstructive voiding dysfunction may lead to more accurate monitoring for urinary retention; early detection of and intervention for urinary retention and potential prevention of sequelae such as urinary tract infection/urosepsis, renal failure, and bladder failure; potential reduction in medical costs and travel burden by reducing unnecessary clinic and emergency room visits as well as the costs of treating potential sequelae of urinary retention; and better quality of life for patients with obstructive voiding dysfunction. Ultrasound technology is non-invasive, uses sound waves (non-ionizing radiation) to produce a volume measurement, and is an exceptionally safe method of imaging with a very limited risk profile.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date June 3, 2022
Est. primary completion date June 3, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient with capacity to consent to the study and completion of informed consent document - Ability to speak and read English Exclusion Criteria: - Patient without capacity to consent to the study or incompletion of informed consent document - Inability to speak and read English

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Butterfly portable ultrasound device with bladder ultrasound images
Point-of-care PVR measurement using existing ultrasound technology (3 consecutive measurements during the same encounter) the Butterfly portable ultrasound device with bladder ultrasound images
Butterfly portable ultrasound device with abstract bladder images
Point-of-care PVR measurement using the Butterfly portable ultrasound device with abstract bladder images

Locations

Country Name City State
United States Yale New Haven Hospital New Haven Connecticut

Sponsors (2)

Lead Sponsor Collaborator
Yale University Butterfly Network, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Accuracy of the patient self-measurement of PVR using the Butterfly portable ultrasound device with bladder ultrasound images compared to the Butterfly portable ultrasound device with abstract bladder images during the same encounter. It is measured by Bland-Altman analysis which describes agreement between two quantitative measurements. More agreement means less difference between measurements. up to 6 months
Primary Accuracy of self-measurement of PVR using the Butterfly with bladder ultrasound images compared to the healthcare provider's measurements of patient PVR using the Butterfly with bladder ultrasound images measured by Bland-Altman analysis. Accuracy of the patient self-measurement of PVR using the Butterfly portable ultrasound device with bladder ultrasound images compared to the healthcare provider's measurements of patient PVR using the Butterfly portable ultrasound device with bladder ultrasound images during the same encounter. It is measured by Bland-Altman analysis which describes agreement between two quantitative measurements. More agreement means less difference between measurements. up to 6 months
Primary Accuracy of self-measurement of PVR using the Butterfly with bladder ultrasound images compared to the healthcare provider's measurements of patient PVR using the Butterfly with abstract bladder images measured by Bland-Altman analysis. Accuracy of the patient self-measurement of PVR using the Butterfly portable ultrasound device with bladder ultrasound images compared to the healthcare provider's measurements of patient PVR using the Butterfly portable ultrasound device with abstract bladder images during the same encounter. It is measured by Bland-Altman analysis which describes agreement between two quantitative measurements. More agreement means less difference between measurements. up to 6 months
Primary Accuracy of patient self-measurement of PVR using the Butterfly with bladder ultrasound images compared to the healthcare provider's measurements of patient PVR using the existing ultrasound technology measured by Bland-Altman analysis. Accuracy of the patient self-measurement of PVR using the Butterfly portable ultrasound device with bladder ultrasound images compared to the healthcare provider's measurements of patient PVR using the existing ultrasound technology during the same encounter. It is measured by Bland-Altman analysis which describes agreement between two quantitative measurements. More agreement means less difference between measurements. up to 6 months
Primary 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. Accuracy of the patient self-measurement of PVR using the Butterfly portable ultrasound device with bladder ultrasound images compared to the healthcare provider's measurements from bladder catheterization of the patient during the same encounter. It is measured by Bland-Altman analysis which describes agreement between two quantitative measurements. More agreement means less difference between measurements. up to 6 months
Secondary Patient Reported Outcomes Questionnaire to asses ease of use, satisfaction, and preference of Butterfly Device Patient Reported Outcomes Questionnaire to assess patient-reported ease of use, satisfaction, and preference between using bladder ultrasound images or abstract bladder images for self measurement of PVR with the Butterfly device using a patient questionnaire at the conclusion of patient self measurements. A mix of open-ended and multiple-choice questions using a 5-point Likert scale of responses. up to 6 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04010656 - Optimization of Spontaneous Postoperative Trial of Void Among Women N/A
Enrolling by invitation NCT05537272 - The Efficacy of Tamsulosin and Tadalafil Compared to Placebo in the Treatment and Prevention of Urinary Disorders After Transperineal Prostate Biopsy Phase 4
Recruiting NCT06070675 - Comparison of a Paper and Automated Bladder Diary in Pediatric Patients N/A
Completed NCT03141372 - Urinary Retention After Total Laparoscopic Hysterectomy With Immediate Foley Catheter Removal Versus Backfill Void Trial N/A
Completed NCT03373773 - Home vs. Office Foley Catheter Removal in Women With Voiding Difficulty Following Pelvic Reconstructive Surgery N/A
Recruiting NCT05490082 - Mirabegron, Propevirine, Solifenacin for Treatment of Lower Urinary Tract Symptoms During Intravesical BCG Instillation Phase 3
Recruiting NCT04429360 - What is the Effect of Prolapse Surgery on Voiding?
Completed NCT03991429 - Brain Imaging in Men With Lower Urinary Tract Symptoms
Completed NCT05182853 - Voiding Disorders in Children After Sacrococcygeal Teratoma Resection
Completed NCT05941260 - Standardization of Prostatic Resection by Virtual Computational Reconstruction and Computational Flow Dynamics
Completed NCT03390790 - Lidocaine for Pain After Urodynamic Testing Phase 4
Completed NCT04928716 - Multiple Sclerosis and Voiding Symptoms: How to Assess?
Completed NCT04064619 - Compare Sudden Stopping and Weaning of Anticholinergics in Recurrence of OAB Symptoms N/A
Not yet recruiting NCT05240456 - Beta 3 Agonists in Treatment of Non-neurogenic Voiding Dysfunction in Children Phase 1/Phase 2
Recruiting NCT03293771 - Transgender Post-reassignment Urogynecologic Measures and Perceptions
Completed NCT03631160 - Effect of Transcutaneous Acupoint Electrical Stimulation on Postoperative Spontaneous Voiding for Laparoscopic Patients N/A
Completed NCT04570605 - Feasibility of Parasacral Transcutaneous Electrical Nerve Stimulation PTENS for Voiding Dysfunction in Peds Population N/A
Completed NCT04184752 - Prevalence of Detrusor Underactivity and Bladder Outlet Obstruction in Female Without Cystocele