Bladder Morphology Using 2 Different Catheter Designs

NCT03108079 | Unknown FDA Device

• 1 other identifier: 03082017
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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)

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

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

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month

Study Arms (1)

Arm 1

OTHER

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.

Device: Cystosure Urinary Access System; Device: Foley Catheter

Interventions

Cystosure Urinary Access System 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)

Also known as: Emmy Medical Cystosure Urinary Access System 10-200

Arm 1

Foley Catheter 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)

Also known as: BARD Medical Foley Catheter

Arm 1

Eligibility Criteria

• Age: 21 Years - 70 Years
• Gender Eligibility Details: Patients in the trial must be female.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Pelvic Floor Institute: lead
• Cystosure: collaborator
• Innovative Research Inc.: collaborator

Study Sites (1)

The Pelvic Floor Institute

Tampa, Florida, 33609, United States

RECRUITING

MeSH Terms

Conditions

Urologic Diseases; Cystitis; Urinary Tract Infections; Mucositis; Catheter-Related Infections; Infections; Pelvic Floor Disorders; Urinary Incontinence

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases; Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lennox Hoyte, MD, MSEECS

  The Pelvic Floor Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lennox Hoyte, MD, MSEECS

CONTACT

813-551-3540; lhoyte@mypfi.org

Jerry B Owens

CONTACT

877-876-2972; innovativeresearchinc@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 11, 2017
• Study Start: April 1, 2017
• Primary Completion: May 1, 2017
• Study Completion: June 1, 2017
• Last Updated: April 12, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)