The objective of this study is to evaluate the safety and essential performance of the C2P System in males with neurogenic lower urinary tract dysfunction (NLUTD), both in an acute clinical setting and an extended period of home use.
Spinal Singularity had developed C2P system to address several drawbacks of current standard-of-care urinary catheters. The C2P is fully internal, urethral indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization, including NLUTD. The C2P is a sterile, single-extended use device that resides fully internally to the male lower urinary tract for an intended service life of up to 29 days per catheter
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
27
The C2P 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 C2P 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.
Northwest Urology Associates, 9151 West Thunderbird Rd, Suite 104
Peoria, Arizona, United States
Northwest Urology Associates, 14674 W. Mountain View Blvd, Suite 210
Surprise, Arizona, United States
West Coast Urology, 11411 Brookshire Avenue, Suite 508
Downey, California, United States
Freedom from genito-urinary injury/trauma
Improved bladder management without injury to genito-urinary tract
Time frame: 3 months
Successful Acute Performance- I
To evaluate successful retention of C2P
Time frame: Day 0 (On the day of C2P insertion)
Successful Acute Performance- II
To evaluate successful bladder voiding with C2P
Time frame: Day 0 (On the day of C2P insertion)
Successful Acute Performance- III
To evaluate successful valve sealing of C2P
Time frame: Day 0 (On the day of C2P insertion)
Successful Home-use Performance
To evaluate successful home use of C2P using same measures as Acute Performance
Time frame: 3 months
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