DirectVision for Urinary Catheterization

NCT03066999 | Terminated Results DMC FDA Device

• 1 other identifier: 16.129.10
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Urethral Diseases

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Cost to Use Cystoscope Versus DirectVision

  7 months

Study Arms (2)

Cystoscopy

ACTIVE COMPARATOR

will have catheter placement using the cystoscopy method

Procedure: Cystoscopy

DirectVision

ACTIVE COMPARATOR

will have catheter placement using DirectVision.

Device: DirectVision

Interventions

Cystoscopy PROCEDURE

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

Cystoscopy

DirectVision DEVICE

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

DirectVision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient over 18 years with a standard indication for difficult urinary catheterization

You may not qualify if:

• Any patient younger than 18 years of age, pregnant patients

Sponsors & Collaborators

• The Pur Clinic: lead
• PercuVision: collaborator

Study Sites (1)

South Lake Hospital

Clermont, Florida, 34711, United States

Location

Related 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. doi: 10.1007/s11934-013-0364-3.

  PMID: 23959835 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Urethral Diseases

Interventions

Cystoscopy

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Results Point of Contact

• Title: Dr Sijo Parekattil
• Organization: PUR Clinic

sijo@orlandohealth.com

3525368761

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of PUR clinic, Investigator

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: March 1, 2017
• Study Start: March 7, 2017
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: July 30, 2019
• Results First Posted: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)