Clinical trial NCT03353571: A Prospective Evaluation of the Catheter Science C3 "Umbrella Catheter."
Official title: A Prospective Evaluation of the Catheter Science C3 "Umbrella Catheter" for Patients With Urinary Retention Due to Bladder Dysfunction (C3 Catheter Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Retention
Urinary Bladder, Neurogenic
Intermittent Catheterization
Lead sponsor: Hammond, Gaines W., Jr., M.D. FACS
Sponsor class: INDIV
First posted: 2017-11-27
Enrollment: 50
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Catheterization of the bladder from an antegrade direction with the C3 device.
timeFrame: Measurement of data points are collected sequentially every 7 days up to 28 days.
measure: The retreat of the C3 back into the bladder from the engaged position
timeFrame: Measurement of data points are collected sequentially every 7 days up to 28 days.
Secondary outcomes:
measure: Reduction in Catheter Acquired Urinary Tract Infection Rate
timeFrame: Measurement of data points are collected sequentially every 7 days up to 28 days.
Other outcomes:
Locations:
city: Lakeland
country: United States
facility: Watson Clinic Llp
state: Florida
Study officials:
References: