The objective of this study is to evaluate the safety and essential performance of the Connected Catheter System in males with neurogenic lower urinary tract dysfunction (NLUTD), both in an acute clinical setting, and during and extended period (up to 29 days) of home use.
The Connected Catheter (C2P) is a replaceable urinary prosthesis that is intended for use in male patients 18 years of age or older who have impaired bladder emptying due to neurogenic lower urinary tract dysfunction, and who are capable of operating the device in accordance with the provided instructions for use, or who have trained caregivers capable of doing the same. The device must be replaced every 29 days
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
5
The Connected Catheter is a fully internal, urethral-indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization, including neurogenic lower urinary tract dysfunction (NLUTD - e.g. due to spinal cord injury). The CoCath is a sterile, single-extended-use device that resides fully internally to the male lower urinary tract (urethra + bladder neck) for an intended service life of up to 29 days per Catheter.
West Coast Urology, 11411 Brookshire Avenue, Suite 508
Downey, California, United States
Tri Valley Urology, 25495 Medical Center Dr., Suite 204
Murrieta, California, United States
Freedom from genito-urinary injury/trauma
Improved bladder management without injury or trauma to genito-urinary tract
Time frame: 29 Days
Successful Acute Performance- I
To evaluate successful retention of Connected Catheter and Void
Time frame: On the day of Connected Catheter Insertion
Successful Acute Performance -II
To evaluate successful bladder voiding with Connected Catheter
Time frame: On the day of Connected Catheter Insertion
Successful Acute Performance- III
To evaluate successful removal of Connected Catheter
Time frame: On the day of Connected Catheter Insertion
Successful Acute Performance- IV
To evaluate successful post-void sealing of Connected Catheter Valve
Time frame: On the day of Connected Catheter Insertion
Successful Home-Use Performance
Successful Home-Use using same measures as Acute Performance
Time frame: 29 days
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