DirectVision for Urinary Catheterization

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.

Study Overview

• Status: Terminated
• Conditions: Urethral Diseases
• Intervention / Treatment: Procedure: Cystoscopy; Device: DirectVision

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Clermont, Florida, United States, 34711
      • South Lake Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Cystoscopy; will have catheter placement using the cystoscopy method	Procedure: Cystoscopy; Patients will assign to either Group Cystoscopy (catheter placement via cystoscopy)
ACTIVE_COMPARATOR: DirectVision; will have catheter placement using DirectVision.	Device: DirectVision; Patients will assign to either Group DirectVision (catheter placement via DirectVision)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Pur Clinic
• Collaborators: PercuVision

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 7, 2017
• Primary Completion (ACTUAL): October 1, 2017
• Study Completion (ACTUAL): October 1, 2017

Study Registration Dates

• First Submitted: February 8, 2017
• First Submitted That Met QC Criteria: February 23, 2017
• First Posted (ACTUAL): March 1, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 30, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urethral Diseases
• Other Study ID Numbers: 16.129.10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will keep the IPD within the research group

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No