Recruiting

Observational Study

Sponsor:

The Pelvic Floor Institute

Code:

NCT03108079

Conditions

Urologic Injuries

Urologic Diseases

Bladder Infection

Urinary Tract Infections

Mucosal Inflammation

Eligibility Criteria

Sex: Female

Age: 21 - 70

Healthy Volunteers: Accepted

Interventions

Cystosure Urinary Access System

Foley Catheter

Study Details

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

Study ID

NCT03108079

Start date

Apr, 2017

Status verified date

Apr, 2017

Completion date

Jun, 2017

Anticipated

Primary completion date

May, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21 - 70

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

3 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: 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.

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)

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)

Primary outcome measure

  • Bladder shape after emptying [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

Lennox Hoyte, MD, MSEECS

813-551-3540lhoyte@mypfi.org

Jerry B Owens

877-876-2972innovativeresearchinc@gmail.com

Locations

The Pelvic Floor Institute

Recruiting

Tampa, Florida, United States, 33609

Contacts

Lennox Hoyte, MD, MSEECS

813-551-3540lhoyte@mypfi.org

Jerry B Owens

877-876-2972innovativeresearchinc@gmail.com

Principal Investigator:

Lennox Hoyte, MD, MSEECS

More Information

Sponsor

The Pelvic Floor Institute

Last update posted

Apr 12, 2017

Last verified

Apr, 2017

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Pelvic Floor Institute on 2017-04-12.