NCT03108079

Bladder Morphology Using 2 Different Catheter Designs

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (estimated)
• Sponsor: The Pelvic Floor Institute · Academic / Other
• Sex: Female
• Age: 21 Years – 70 Years
• Healthy volunteers: Accepted

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.

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

Type	Name	Description
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)

Timeline

• Start date: 2017-04-01
• Primary completion: 2017-05-01
• Completion: 2017-06-01
• First posted: 2017-04-11
• Last updated: 2017-04-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study