Bladder Morphology Using 2 Different Catheter Designs

Urinary Incontinence Clinical Trial

Official title:

Bladder Morphology Using 2 Different Catheter Designs Foley Catheter vs. Cystosure Urinary Access System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03108079
• Other study ID #: 03082017
• Status: Recruiting
• Phase: N/A
• First received: March 30, 2017
• Last updated: April 10, 2017
• Start date: April 2017
• Est. completion date: June 2017

Study information

• Verified date: April 2017
• Source: The Pelvic Floor Institute
• Contact: Lennox Hoyte, MD, MSEECS
• Phone: 813-551-3540
• Email: lhoyte[@]mypfi.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3
• Est. completion date: June 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Infection
• Bladder Injury
• Catheter Complications
• Catheter-Related Infections
• Catheter; Infection (Indwelling Catheter)
• Communicable Diseases
• Cystitis
• Enuresis
• Infection
• Inflammation
• Mucosal Infection
• Mucosal Inflammation
• Mucositis
• Pelvic Floor Disorders
• Urinary Incontinence
• Urinary Tract Infections
• Urologic Diseases
• Urologic Injuries
• Wounds and Injuries

Intervention

Device:
• Cystosure Urinary Access System
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)
• 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)

Locations

Country	Name	City	State
United States	The Pelvic Floor Institute	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
The Pelvic Floor Institute	Cystosure, Innovative Research Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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