DirectVision for Urinary Catheterization

• Sponsor: The Pur Clinic (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03066999
• Collaborator: PercuVision (Other)
• Enrollment: 5
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.8
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urethral Diseases	Procedure: Cystoscopy; Device: DirectVision	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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
• Actual Study Start Date: Mar 7, 2017
• Actual Primary Completion Date: Oct 1, 2017
• Actual Study Completion Date: Oct 1, 2017

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Set up Time/Total Procedure Time to Place Catheter Via DirectVision/Cystoscope [prep and duration of procedure, up to 1 hour]

   Duration to set up and complete the procedure either by DirectVision or Cystoscope was observed and calculated by minutes.

2. Effectiveness of DirectVision-adverse Events [7 months]

   assessment will be done by reviewing the number of Participants who had adverse events that are related to the procedures.

3. Ancillary Tools Used [duration of procedure]

   Ancillary tools used wire, SPT, etc

4. Procedure Findings [duration of procedure]

   Procedure findings 1- Obliterated urethra 2-High bladder neck 3-Normal urethra 4-Urethral stricture 5-Bladder neck contracture

5. Degree of Difficulty [duration of procedure]

   Degree of difficulty defined as easy versus difficult

6. Presence of Pain and Hematuria [duration of procedure]

   To compare DirectVision to the cystoscope we compared if patients experienced pain or hematuria

Secondary Outcome Measures

1. Cost to Use Cystoscope Versus DirectVision [7 months]

   The investigators will look at the cost using the DirectVision versus the cystoscope with costs of ancillary tools used during the procedures.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	South Lake Hospital	Clermont	Florida	United States	34711

Sponsors and Collaborators

• The Pur Clinic
• PercuVision

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 28, 2017
• Informed Consent Form - Jul 26, 2017

More Information

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. Review.

• Responsible Party: Sijo J. Parekattil, M.D., Director of PUR clinic, Investigator, The Pur Clinic
• ClinicalTrials.gov Identifier: NCT03066999
• Other Study ID Numbers: 16.129.10
• First Posted: Mar 1, 2017
• Last Update Posted: Jul 30, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Urethral Diseases

Study Results

Participant Flow

Pre-assignment Detail	No enrolled patients were excluded from the study before assignment to groups

Arm/Group Title	Cystoscopy	DirectVision
Arm/Group Description	Patient will have catheter placement using the cystoscopy method	Patient will have catheter placement using DirectVision.
Period Title: Overall Study
STARTED	2	3
COMPLETED	2	1
NOT COMPLETED	0	2

Baseline Characteristics

Arm/Group Title	Cystoscopy	DirectVision	Total
Arm/Group Description	will have catheter placement using the cystoscopy method	will have catheter placement using DirectVision	Total of all reporting groups
Overall Participants	2	3	5
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	2 100%	3 100%	5 100%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	2 100%	3 100%	5 100%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
History of urological procedures (Count of Participants)
Count of Participants [Participants]	2 100%	2 66.7%	4 80%

Outcome Measures

1. Primary Outcome

Title	Set up Time/Total Procedure Time to Place Catheter Via DirectVision/Cystoscope
Description	Duration to set up and complete the procedure either by DirectVision or Cystoscope was observed and calculated by minutes.
Time Frame	prep and duration of procedure, up to 1 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cystoscopy	DirectVision
Arm/Group Description	will have catheter placement using the cystoscope	will have catheter placement using DirectVision.
Measure Participants	2	3
Set up time- in minutes	15	26.67
procedure time	5	23.33

2. Primary Outcome

Title	Effectiveness of DirectVision-adverse Events
Description	assessment will be done by reviewing the number of Participants who had adverse events that are related to the procedures.
Time Frame	7 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cystoscopy	DirectVision
Arm/Group Description	will have catheter placement using the cystoscopy method	will have catheter placement using DirectVision.
Measure Participants	2	3
Count of Participants [Participants]	0 0%	0 0%

3. Primary Outcome

Title	Ancillary Tools Used
Description	Ancillary tools used wire, SPT, etc
Time Frame	duration of procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cystoscopy	DirectVision
Arm/Group Description	will have catheter placement using the cystoscope	will have catheter placement using DirectVision.
Measure Participants	2	3
Number [tools]	2	2

4. Primary Outcome

Title	Procedure Findings
Description	Procedure findings 1- Obliterated urethra 2-High bladder neck 3-Normal urethra 4-Urethral stricture 5-Bladder neck contracture
Time Frame	duration of procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cystoscopy	DirectVision
Arm/Group Description	will have catheter placement using the cystoscope	will have catheter placement using DirectVision.
Measure Participants	2	3
Obliterated urethra	0 0%	1 33.3%
High bladder neck	1 50%	0 0%
Normal urethral profile	0 0%	1 33.3%
Urethral stricture	1 50%	0 0%
Bladder neck contracture	0 0%	1 33.3%

5. Primary Outcome

Title	Degree of Difficulty
Description	Degree of difficulty defined as easy versus difficult
Time Frame	duration of procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cystoscopy	DirectVision
Arm/Group Description	will have catheter placement using the cystoscope	will have catheter placement using DirectVision.
Measure Participants	2	3
Easy	2 100%	1 33.3%
Difficult	0 0%	2 66.7%

6. Primary Outcome

Title	Presence of Pain and Hematuria
Description	To compare DirectVision to the cystoscope we compared if patients experienced pain or hematuria
Time Frame	duration of procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cystoscopy	DirectVision
Arm/Group Description	will have catheter placement using the cystoscope	will have catheter placement using DirectVision.
Measure Participants	2	3
Presence of hematuria	1 50%	1 33.3%
Presence of pain	0 0%	0 0%

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cystoscopy	DirectVision
Arm/Group Description	will have catheter placement using the cystoscopy method	will have catheter placement using DirectVision.
Measure Participants	2	3
Mean (Full Range) [Cost in dollars per patient]	174	187

Adverse Events

Time Frame	From procedure through discharge from hospital
Adverse Event Reporting Description	No adverse event noted
Arm/Group Title	Cystoscopy		DirectVision
Arm/Group Description	will have catheter placement using the cystoscopy method		will have catheter placement using DirectVision.
All Cause Mortality
	Cystoscopy		DirectVision
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/3 (0%)
Serious Adverse Events
	Cystoscopy		DirectVision
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	Cystoscopy		DirectVision
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/3 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.