Are you healthy and looking to help advance medical science?

You may be eligible to participate in a bladder infection clinical study, and could be compensated for your time.

Are you healthy and looking to help advance medical science? You may be eligible to participate in a bladder infection clinical study, and could be compensated for your time.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Bladder Infection Clinical Trial in Tampa FL

NCT03108079 | Interventional

Are you healthy and looking to help advance medical science?

You may be eligible to participate in a bladder infection clinical study, and could be compensated for your time.

Are you healthy and looking to help advance medical science? You may be eligible to participate in a bladder infection clinical study, and could be compensated for your time.

Recruiting

Female

21 - 70

Years old

This study is looking to recruit 3 Participants

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)

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Details for the study

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

Brief Summary

Demonstrate and compare the 3D morphology of the bladder wall in full and drained states with<br /> 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.

Treatments and/or Procedures

Foley catheter

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)

Cystosure urinary access system

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

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 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.