Bladder Morphology Using 2 Different Catheter Designs

NCT ID: NCT03108079

Last Updated: 2017-04-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-30
• Study Completion Date: 2017-06-30

Brief Summary

Demonstrate and compare the 3D morphology of the bladder wall in full and drained states with 2 different kinds of bladder catheters in place. (Foley Catheter vs. Cystosure Catheter)

Detailed Description

The Foley catheter has been the mainstay of bladder drainage for many decades. There has been little design change despite risks associated with Foley catheter use including cather associated Urinary Tract Infections(UTIs). However, recent incentives and penalties related to iatrogenic bladder infections have encouraged healthcare providers to search for ways to decrease catheter-associated infections. Data suggests that the design of the traditional Foley catheter may be responsible for bladder mucosal injury due to contact with the drainage tip, which in turn contribute to bladder infections associated with long term indwelling Foley catheter usage. The Cystosure catheter is an FDA approved bladder drainage device, with a shortened drainage port, designed to avoid contact with the bladder mucosa. It is postulated that the lack of contact with the mucosa would decrease mucosal injury, possibly leading to decreased incidence of catheter related bladder infections. Early sheep bladder microscopy studies have suggested that the Cystosure catheter produces significantly less mucosal injury compared to the Foley catheter following a short period of indwelling bladder catheterization. The present study is designed to compare bladder wall geometry around the drainage balloon in the Foley versus the Cystosure drainage catheters in living women. It is hypothesized that the "tip-less" cystosure catheter will have a smoother, more continuous bladder contour around the drainage port, compared to the traditional Foley catheter tip.

Conditions

Urologic Injuries; Urologic Diseases; Bladder Infection; Urinary Tract Infections; Mucosal Inflammation; Mucosal Infection; Bladder Injury; Catheter-Related Infections; Catheter Complications; Catheter; Infection (Indwelling Catheter); Pelvic Floor Disorders; Urinary Incontinence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Arm 1

Women who agree to participate will undergo a standard high resolution, thin slice pelvic floor static/dynamic MRI study, first with a full bladder, and after the bladder is emptied. Bladder filling and drainage will be performed sequentially, using each of the 2 catheter types (Cystosure Urinary Access Catheter and Foley Catheter). During bladder emptying, a cine video scan will be taken at the midsagittal plane to show the dynamics of the bladder fluid and walls during emptying. Each subject will serve as their own control.

Interventions are listed in the "Interventions" Section.

Group Type: OTHER

Cystosure Urinary Access System

Intervention Type: DEVICE

1. Demonstrate the 3D bladder wall anatomy with 300 cc of fluid infused with each of the following bladder drainage mechanisms

1. The traditional Foley catheter (Catheter A)

2. The novel FDA approved Cystosure catheter (Catheter B)

2. Compare the fluid flow pattern during bladder drainage for

1. The traditional Foley catheter (Catheter A)

2. The novel FDA approved Cystosure catheter (Catheter B)

3. Compare the 3D bladder wall anatomy after emptying the bladder with

1. The traditional Foley catheter (Catheter A)

2. The novel FDA approved Cystosure catheter (Catheter B)

Foley Catheter

Intervention Type: DEVICE

1. Demonstrate the 3D bladder wall anatomy with 300 cc of fluid infused with each of the following bladder drainage mechanisms

1. The traditional Foley catheter (Catheter A)

2. The novel FDA approved Cystosure catheter (Catheter B)

2. Compare the fluid flow pattern during bladder drainage for

1. The traditional Foley catheter (Catheter A)

2. The novel FDA approved Cystosure catheter (Catheter B)

3. Compare the 3D bladder wall anatomy after emptying the bladder with

1. The traditional Foley catheter (Catheter A)

2. The novel FDA approved Cystosure catheter (Catheter B)

Interventions

Cystosure Urinary Access System

1. Demonstrate the 3D bladder wall anatomy with 300 cc of fluid infused with each of the following bladder drainage mechanisms

1. The traditional Foley catheter (Catheter A)

2. The novel FDA approved Cystosure catheter (Catheter B)

2. Compare the fluid flow pattern during bladder drainage for

1. The traditional Foley catheter (Catheter A)

2. The novel FDA approved Cystosure catheter (Catheter B)

3. Compare the 3D bladder wall anatomy after emptying the bladder with

1. The traditional Foley catheter (Catheter A)

2. The novel FDA approved Cystosure catheter (Catheter B)

Intervention Type: DEVICE

Foley Catheter

1. Demonstrate the 3D bladder wall anatomy with 300 cc of fluid infused with each of the following bladder drainage mechanisms

1. The traditional Foley catheter (Catheter A)

2. The novel FDA approved Cystosure catheter (Catheter B)

2. Compare the fluid flow pattern during bladder drainage for

1. The traditional Foley catheter (Catheter A)

2. The novel FDA approved Cystosure catheter (Catheter B)

3. Compare the 3D bladder wall anatomy after emptying the bladder with

1. The traditional Foley catheter (Catheter A)

2. The novel FDA approved Cystosure catheter (Catheter B)

Intervention Type: DEVICE

Other Intervention Names

Emmy Medical Cystosure Urinary Access System 10-200; BARD Medical Foley Catheter

Eligibility Criteria

Inclusion Criteria

• Pelvic Floor Institute patients aged between 21 and 70 years of age, who are able to speak and understand English, who are not currently pregnant, or had a pregnancy in the previous 6 months.

Exclusion Criteria

• Women with claustrophobia or any contraindication to undergoing an MRI scan will be excluded. Similarly, women with hip, knee, or shoulder replacements will be excluded because of the need for urethral catheterization. Women with significant mitral valve prolapse will also be excluded for the same reason. Women with history of 3 or more culture-documented UTIs over the last 12 months will be excluded. Women who are unable or unwilling to give informed consent will also be excluded. Women who are unable to tolerate 300 cc of fluid in the bladder will be excluded. Women with a nitrite-positive urinalysis at the time of study enrollment will be excluded until they can demonstrate a negative urine culture.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cystosure

UNKNOWN

Sponsor Role: collaborator

Innovative Research Inc.

UNKNOWN

Sponsor Role: collaborator

The Pelvic Floor Institute

OTHER

Sponsor Role: lead

Responsible Party

Lennox Hoyte, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lennox Hoyte, MD, MSEECS

Role: PRINCIPAL_INVESTIGATOR

The Pelvic Floor Institute

Locations

The Pelvic Floor Institute

Tampa, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lennox Hoyte, MD, MSEECS

Role: CONTACT

lhoyte@mypfi.org

813-551-3540

Jerry B Owens

Role: CONTACT

innovativeresearchinc@gmail.com

877-876-2972

Facility Contacts

Lennox Hoyte, MD, MSEECS

Role: primary

lhoyte@mypfi.org

813-551-3540

Jerry B Owens

Role: backup

innovativeresearchinc@gmail.com

877-876-2972

Other Identifiers

03082017

Identifier Type: -

Identifier Source: org_study_id