DirectVision for Urinary Catheterization

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessment of the Effectiveness and Ease of Use of DirectVision- a Direct Visualization System for Urinary Catheterization: Results of a Single Center Prospective Study

Conditions
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Urethral Diseases

Intervention / Treatment
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* Procedure: Cystoscopy
* Device: DirectVision


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cystoscopy<br>will have catheter placement using the cystoscopy method | Procedure: Cystoscopy<br>* Patients will assign to either Group Cystoscopy (catheter placement via cystoscopy)<br>|
| Active Comparator: DirectVision<br>will have catheter placement using DirectVision. | Device: DirectVision<br>* Patients will assign to either Group DirectVision (catheter placement via DirectVision)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Set up Time/Total Procedure Time to Place Catheter Via DirectVision/Cystoscope | Duration to set up and complete the procedure either by DirectVision or Cystoscope was observed and calculated by minutes. | prep and duration of procedure, up to 1 hour | 
| Effectiveness of DirectVision-adverse Events | assessment will be done by reviewing the number of Participants who had adverse events that are related to the procedures. | 7 months | 
| Ancillary Tools Used | Ancillary tools used wire, SPT, etc | duration of procedure | 
| Procedure Findings | Procedure findings 1- Obliterated urethra 2-High bladder neck 3-Normal urethra 4-Urethral stricture 5-Bladder neck contracture | duration of procedure | 
| Degree of Difficulty | Degree of difficulty defined as easy versus difficult | duration of procedure | 
| Presence of Pain and Hematuria | To compare DirectVision to the cystoscope we compared if patients experienced pain or hematuria | duration of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost to Use Cystoscope Versus DirectVision | The investigators will look at the cost using the DirectVision versus the cystoscope with costs of ancillary tools used during the procedures. | 7 months |