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

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ClinicalTrials.gov Identifier: NCT03353571
Recruitment Status : Recruiting
First Posted : November 27, 2017
Last Update Posted : November 27, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Gaines W. Hammond Jr. MD FACS, Hammond, Gaines W., Jr., M.D. FACS

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Urinary Retention Urinary Bladder, Neurogenic Intermittent Catheterization Device: C3 "UMBRELLA CATHETER" Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description:

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.

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.

Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Prospective Evaluation of the Catheter Science C3 "Umbrella Catheter" for Patients With Urinary Retention Due to Bladder Dysfunction (C3 Catheter Study)
Actual Study Start Date : August 31, 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Catheterization of the bladder from an antegrade direction with the C3 device. [ Time Frame: Measurement of data points are collected sequentially every 7 days up to 28 days. ]
    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.

  2. The retreat of the C3 back into the bladder from the engaged position [ Time Frame: Measurement of data points are collected sequentially every 7 days up to 28 days. ]
    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.


Secondary Outcome Measures :
  1. Reduction in Catheter Acquired Urinary Tract Infection Rate [ Time Frame: Measurement of data points are collected sequentially every 7 days up to 28 days. ]
    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.



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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353571


Contacts
Contact: GAINES W HAMMOND, MD 863-680-7300 GHAMMOND@WATSONCLINIC.COM
Contact: ELAYNE HALL 863-680-7300 EHALL@WATSONCLINIC.COM

Locations
United States, Florida
Watson Clinic Llp Recruiting
Lakeland, Florida, United States, 33805
Contact: GAINES W HAMMOND, MD    863-680-7300    GHAMMOND@WATSONCLINIC.COM   
Contact: ELAYNE HALL    863-680-7300    EHALL@WATSONCLINIC.COM   
Sponsors and Collaborators
Dr. Gaines W. Hammond Jr. MD FACS

Responsible Party: Dr. Gaines W. Hammond Jr. MD FACS, SPONSOR- INVESTIGATOR, Hammond, Gaines W., Jr., M.D. FACS
ClinicalTrials.gov Identifier: NCT03353571     History of Changes
Other Study ID Numbers: Study # 17/30/08
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: LISTED IN STUDY INFORMED CONSENT WITH NAME RECOGNITION WITHHELD
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: After completion of the study which is anticipated to be March 2018 for a period of 2 years post completion.
Access Criteria: Access with proper credentials with the patient identifying markers withheld.
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Urinary Retention
Urinary Bladder, Neurogenic
Urination Disorders
Urologic Diseases
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Signs and Symptoms