Urethral Diseases Clinical Trial
Official title:
Assessment of the Effectiveness and Ease of Use of DirectVision- a Direct Visualization System for Urinary Catheterization: Results of a Single Center Prospective Study
The Center for Disease Control and Prevention (CDC) reports that one in four patients
hospitalized in the United States is catheterized to void the bladder or monitor urinary
output. In the male population, Dr. Singh, an urologist estimates that about 20% of
catheterizations are difficult. Driving a catheter blindly, guessing whether to push the
catheter forward or manipulate it to get around a point of resistance leads to the risk of
injury which increases the more the catheter is manipulated. Additional adverse events
include: urosepsis, UTI and bladder perforation. The standard of care treatment for patients
with difficult urinary catheterization (DUC) is to proceed with a cystoscopic catheter
placement or suprapubic tube placement.
PercuVision has the only Foley catheter with a micro-endoscope for visualization and
navigation of the urethra for nurses and other qualified health care professionals. Moreover,
it allows urologists to place a guidewire under direct vision rather than calling for a
flexible cystoscope which is considered a minor procedure.
In this study, the investigators plan on assessing the effectiveness and ease of use of the
PercuVision DirectVision® System device.
Routine placement of transurethral catheters can be challenging in some situations, such as
urethral strictures, severe phimosis and false passages. Intravaginal retraction of the
urethral meatus can complicate Foley placement in postmenopausal females. In men, blind
urethral procedures with mechanical or metal sounds without visual guidance or guidewire
assistance are now discouraged due to the increased risk of urethral trauma and false
passages.
DirectVision is a new visually-guided catheterization device (VGCD) that uses a camera visual
guide / microendoscope within a triple lumen flexible urinary catheter with an angled tip,
essentially combining the functionality of a urinary catheter with a cystoscope. DirectVision
uses fiber-optic bundle of 6,000 integrated fibers to provide illumination and transmit
real-time video.
Procedures done via flexible cystoscopy or DirectVision are covered by insurance (including
Medicaid/Medicare).
In this prospective study, the investigators plan on assessing the effectiveness and ease of
use of DirectVision - A direct visualization system for urinary catheterization.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03757975 -
Impact of Hysterectomy on Quality of Life and Urethral Length
|