A Prospective Evaluation of the Catheter Science C3 "Umbrella Catheter."
| Status: | Recruiting |
|---|---|
| Conditions: | Overactive Bladder, Urology |
| Therapuetic Areas: | Gastroenterology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 11/29/2017 |
| Start Date: | August 31, 2017 |
| End Date: | March 2018 |
| Contact: | GAINES W HAMMOND, MD |
| Email: | GHAMMOND@WATSONCLINIC.COM |
| Phone: | 863-680-7300 |
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.
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.
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.
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.
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
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