A Prospective Evaluation of the Catheter Science C3 "Umbrella Catheter."

A Prospective Evaluation of the Catheter Science C3 "Umbrella Catheter" for Patients With Urinary Retention Due to Bladder Dysfunction (C3 Catheter Study)

The Catheter Science C3 "Umbrella Catheter" has been developed for management of urinary retention in patients who are either using a Foley or Self Intermittent Catheter. This device is inserted into the bladder in an extended state and once the stylet is removed the device folds into collapsed state. A thread is attached to the device and traverses thru the urethra and is attached to a bobber. With gentle traction on the thread the device engages the bladder neck and the central tube extends which allows for the flow of urine. Once voiding is complete, the thread is released and the device collapses back to the folded state into the bladder. Each voiding cycle is accomplished in a similar fashion. This is a novel technique in which the bladder is catheterized with the device from within the bladder into the bladder neck and urethra. The standard self catheter technique is for placement of a catheter from the outside into the urethra and into the bladder.

Study Overview

• Status: Unknown
• Conditions: Urinary Retention; Urinary Bladder, Neurogenic; Intermittent Catheterization
• Intervention / Treatment: Device: C3 "UMBRELLA CATHETER"

Detailed Description

Interventional (clinical trial): Participants are assigned prospectively to an intervention or interventions according to a protocol to evaluate the effect of the intervention(s) on biomedical or other health related outcomes.

This single arm, prospective study is designed to produce valid scientific evidence regarding:

1. Safety and efficacy of the Catheter Science C3 "Umbrella Catheter" in establishing urinary drainage and allowing the control of micturition when indwelling for up to 7 days.
2. The reduction in Catheter Acquired Urinary Tract Infection (CAUTI)

A single arm study design was chosen because there is no alternative treatment to serve as an appropriate control. The C3 catheterizes the bladder with engagement into the bladder neck under the control of the patient or care giver. A Foley catheter, a pre- amendment device, was considered for a control treatment. However, although a Foley catheter is used to establish urinary drainage with close to 100% efficacy, it does not restore voiding function like the C3, and severely impairs activities of daily life.

The intrinsic design flaws of a Foley catheter traversing thru the urinary passage which violates the anatomical protective points which help to avoid bacterial contamination. The distal 1/3 portion of the urethra in females is commonly colonized with bacteria. Standard Catheter technique traverses from the outside into the entire length of the urethra to drain the bladder. The standard self catheter flow characteristics are impacted due to the placements of the "eyes" to the catheter lumen. The C3 lumen is open in line with the flow.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Lakeland, Florida, United States, 33805
      • Recruiting
      • Watson Clinic LLP
      • Contact: GAINES W HAMMOND, MD; Phone Number: 863-680-7300; Email: GHAMMOND@WATSONCLINIC.COM
      • Contact: ELAYNE HALL; Phone Number: 863-680-7300; Email: EHALL@WATSONCLINIC.COM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Patients with Bladder Dysfunction requiring mechanical drainage.
2. Patients with actual urinary retention

Exclusion Criteria:

1. Inability to undergo bladder catheterization (e.g., urethral stricture or history of urethral stricture)
2. Gross hematuria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: C3 PATIENT PARTICIPANTS; This single arm prospective study is designed to produce valid scientific evidence regarding safety and efficacy of the C3 in establishing urinary drainage and allowing the control of micturition when indwelling for up to 7 days in patients. The total study population will initially include 50 subjects with open enrollment of additional subjects.	Device: C3 "UMBRELLA CATHETER"; The C3 is an alternative method to facilitate bladder drainage in the study population which are using either a foley catheter or Clean Intermittent Catheter technique to drain the bladder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Catheterization of the bladder from an antegrade direction with the C3 device.	The percentage for patients enrolled in the student with the C3 inserted who are able to engage the tubular portion of the device into the bladder neck and urethra from the default position in the bladder with resultant drainage of the bladdder.	Measurement of data points are collected sequentially every 7 days up to 28 days.
The retreat of the C3 back into the bladder from the engaged position	The percentage of enrolled patients who upon completion of bladder drainage with the engaged tubular portion of the C3 in bladder neck and urethral location retreats back into the default position in the bladder.	Measurement of data points are collected sequentially every 7 days up to 28 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Catheter Acquired Urinary Tract Infection Rate	The reduction in Catheter Acquired Urinary Tract Infection (CAUTI) with the C3 "Umbrella Catheter" as compared to the expected incidence with either a Foley Catheter or Self Intermittent Catheter for bladder drainage.	Measurement of data points are collected sequentially every 7 days up to 28 days.

Collaborators and Investigators

• Sponsor: Dr. Gaines W. Hammond Jr. MD FACS

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2017
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: October 24, 2017
• First Submitted That Met QC Criteria: November 20, 2017
• First Posted (Actual): November 27, 2017

Study Record Updates

• Last Update Posted (Actual): November 27, 2017
• Last Update Submitted That Met QC Criteria: November 20, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Urologic Diseases; Urinary Bladder Diseases; Neurologic Manifestations; Urination Disorders; Urinary Bladder, Neurogenic; Urinary Retention
• Other Study ID Numbers: Study # 17/30/08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: LISTED IN STUDY INFORMED CONSENT WITH NAME RECOGNITION WITHHELD
• IPD Sharing Time Frame: After completion of the study which is anticipated to be March 2018 for a period of 2 years post completion.
• IPD Sharing Access Criteria: Access with proper credentials with the patient identifying markers withheld.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No