DirectVision for Urinary Catheterization

The Pur Clinic

Status: Terminated

Conditions: Urethral Diseases

Treatments: Procedure: Cystoscopy; Device: DirectVision

Study type: Interventional

Funder types: Other

Identifiers

NCT03066999

16.129.10

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Any patient over 18 years with a standard indication for difficult urinary catheterization

Exclusion criteria

• Any patient younger than 18 years of age, pregnant patients

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Cystoscopy

Active Comparator group

Description:

will have catheter placement using the cystoscopy method

Treatment:

Procedure: Cystoscopy

DirectVision

Active Comparator group

Description:

will have catheter placement using DirectVision.

Treatment:

Device: DirectVision