Clinical trial NCT03066999: DirectVision for Urinary Catheterization
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Urethral Diseases
Lead sponsor: The Pur Clinic
Sponsor class: OTHER
Collaborators: name: PercuVision
First posted: 2017-03-01
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Set up Time/Total Procedure Time to Place Catheter Via DirectVision/Cystoscope
timeFrame: prep and duration of procedure, up to 1 hour
measure: Effectiveness of DirectVision-adverse Events
timeFrame: 7 months
measure: Ancillary Tools Used
timeFrame: duration of procedure
measure: Procedure Findings
timeFrame: duration of procedure
measure: Degree of Difficulty
timeFrame: duration of procedure
measure: Presence of Pain and Hematuria
timeFrame: duration of procedure
Secondary outcomes:
measure: Cost to Use Cystoscope Versus DirectVision
timeFrame: 7 months
Other outcomes:
Locations:
city: Clermont
country: United States
facility: South Lake Hospital
state: Florida
Study officials:
References:
citation: Ghaffary C, Yohannes A, Villanueva C, Leslie SW. A practical approach to difficult urinary catheterizations. Curr Urol Rep. 2013 Dec;14(6):565-79. doi: 10.1007/s11934-013-0364-3.