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Bladder Morphology Using 2 Different Catheter Designs

Primary Purpose

Urologic Injuries, Urologic Diseases, Bladder Infection

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cystosure Urinary Access System
Foley Catheter
Sponsored by
The Pelvic Floor Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Urologic Injuries focused on measuring 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

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • The Pelvic Floor InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm 1

Arm Description

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.

Outcomes

Primary Outcome Measures

Bladder shape after emptying
Bladder shape after emptying using both catheters will be assessed. The 3D reconstructed images will be compared to determine if there are any differences in bladder shape in full and empty states between the 2 catheter types.

Secondary Outcome Measures

Full Information

First Posted
March 30, 2017
Last Updated
April 10, 2017
Sponsor
The Pelvic Floor Institute
Collaborators
Cystosure, Innovative Research Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03108079
Brief Title
Bladder Morphology Using 2 Different Catheter Designs
Official Title
Bladder Morphology Using 2 Different Catheter Designs Foley Catheter vs. Cystosure Urinary Access System
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2017 (Anticipated)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Pelvic Floor Institute
Collaborators
Cystosure, Innovative Research Inc.

4. Oversight

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.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Female patients seen at the Pelvic Floor Institute will be offered participation in the study. The study will consist of a pelvic floor MRI at no cost to them or their payors. 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 (A and B above) in sequence. 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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cystosure Urinary Access System
Other Intervention Name(s)
Emmy Medical Cystosure Urinary Access System 10-200
Intervention Description
Demonstrate the 3D bladder wall anatomy with 300 cc of fluid infused with each of the following bladder drainage mechanisms The traditional Foley catheter (Catheter A) The novel FDA approved Cystosure catheter (Catheter B) Compare the fluid flow pattern during bladder drainage for The traditional Foley catheter (Catheter A) The novel FDA approved Cystosure catheter (Catheter B) Compare the 3D bladder wall anatomy after emptying the bladder with The traditional Foley catheter (Catheter A) The novel FDA approved Cystosure catheter (Catheter B)
Intervention Type
Device
Intervention Name(s)
Foley Catheter
Other Intervention Name(s)
BARD Medical Foley Catheter
Intervention Description
Demonstrate the 3D bladder wall anatomy with 300 cc of fluid infused with each of the following bladder drainage mechanisms The traditional Foley catheter (Catheter A) The novel FDA approved Cystosure catheter (Catheter B) Compare the fluid flow pattern during bladder drainage for The traditional Foley catheter (Catheter A) The novel FDA approved Cystosure catheter (Catheter B) Compare the 3D bladder wall anatomy after emptying the bladder with The traditional Foley catheter (Catheter A) The novel FDA approved Cystosure catheter (Catheter B)
Primary Outcome Measure Information:
Title
Bladder shape after emptying
Description
Bladder shape after emptying using both catheters will be assessed. The 3D reconstructed images will be compared to determine if there are any differences in bladder shape in full and empty states between the 2 catheter types.
Time Frame
1 month

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Patients in the trial must be female.
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lennox Hoyte, MD, MSEECS
Phone
813-551-3540
Email
lhoyte@mypfi.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jerry B Owens
Phone
877-876-2972
Email
innovativeresearchinc@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lennox Hoyte, MD, MSEECS
Organizational Affiliation
The Pelvic Floor Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Pelvic Floor Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lennox Hoyte, MD, MSEECS
Phone
813-551-3540
Email
lhoyte@mypfi.org
First Name & Middle Initial & Last Name & Degree
Jerry B Owens
Phone
877-876-2972
Email
innovativeresearchinc@gmail.com
First Name & Middle Initial & Last Name & Degree
Lennox Hoyte, MD, MSEECS

12. IPD Sharing Statement

Plan to Share IPD
No

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Bladder Morphology Using 2 Different Catheter Designs

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