Clinical trial NCT03108079: 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
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: The Pelvic Floor Institute
Sponsor class: OTHER
Collaborators: name: Cystosure
name: Innovative Research Inc.
First posted: 2017-04-11
Enrollment: 3
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Bladder shape after emptying
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: The Pelvic Floor Institute
state: Florida
Study officials:
affiliation: The Pelvic Floor Institute
name: Lennox Hoyte, MD, MSEECS
role: PRINCIPAL_INVESTIGATOR
References: