DirectVision for Urinary Catheterization

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03066999
• Other study ID #: 16.129.10
• Status: Terminated
• Phase: N/A
• Start date: March 7, 2017
• Est. completion date: October 1, 2017

Study information

• Verified date: July 2019
• Source: The Pur Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: October 1, 2017
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urethral Diseases

Intervention

Procedure:
• Cystoscopy
Patients will assign to either Group Cystoscopy (catheter placement via cystoscopy)

Device:
• DirectVision
Patients will assign to either Group DirectVision (catheter placement via DirectVision)

Locations

Country	Name	City	State
United States	South Lake Hospital	Clermont	Florida

Sponsors (2)

Lead Sponsor	Collaborator
The Pur Clinic	PercuVision

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ghaffary C, Yohannes A, Villanueva C, Leslie SW. A practical approach to difficult urinary catheterizations. Curr Urol Rep. 2013 Dec;14(6):565-79. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Ancillary Tools Used	Ancillary tools used wire, SPT, etc	duration of procedure
Primary	Procedure Findings	Procedure findings; 1- Obliterated urethra; 2-High bladder neck; 3-Normal urethra; 4-Urethral stricture; 5-Bladder neck contracture	duration of procedure
Primary	Degree of Difficulty	Degree of difficulty defined as easy versus difficult	duration of procedure
Primary	Presence of Pain and Hematuria	To compare DirectVision to the cystoscope we compared if patients experienced pain or hematuria	duration of procedure
Secondary	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

External Links

•   Feasibility study of a visually guided male urinary catheterization device by Banks et al.Journal of Urology. 2009; 181(4): p454.