Bladder Morphology Using 2 Different Catheter Designs

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

Interventions

DEVICE

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)

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)

Sponsors & Collaborators

• Cystosure

  collaborator UNKNOWN

• Innovative Research Inc.

  collaborator UNKNOWN

• The Pelvic Floor Institute

  lead OTHER

Principal Investigators

• Lennox Hoyte, MD, MSEECS · The Pelvic Floor Institute

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

21 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-04-30

Primary Completion

2017-05-31

Completion

2017-06-30

FDA Device

Yes

Countries

• United States

Study Locations