The Connected Catheter is a fully internal, urethral indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization. It is a sterile, extended-use device that resides fully internally to the male lower urinary tract for an intended use life of up to 7 days per catheter.
Spinal Singularity has developed the Connected Catheter System to address several drawbacks of urinary catheters. The Connected Catheter is fully internal, indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization. Each subject will use the Connected Catheter for up to 35-40 days. This includes five device exchange appointments. The appointments are spaced 7 days apart and at each appointment the catheter will be replaced with a new one. Additionally, weekly follow-up will occur for 14 days following the final appointment after the subject discontinues use of study device and reverts to his original catheter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
9
Patients will use the Connected Catheter to empty the bladder during the course of treatment.
West Coast Urology, 11411 Brookshire Avenue, Suite 508
Downey, California, United States
West Coast Urology, 575 E. Hardy St., Suite 215
Inglewood, California, United States
Tri Valley Urology, 25495 Medical Center Dr., Suite 204
Murrieta, California, United States
Successful Bladder Emptying Using Connected Catheter
Rate of participants with successful voiding using the Connected Catheter as assessed by Post-Residual Volume (PVR) measurement via ultrasound A subject is considered a responder to the treatment if a minimum of 80% of their PVR values met the following criteria PVR is ≤ 50 mL OR PVR is ≤ baseline PVR with the standard of care catheter
Time frame: 35-40 days
Rate of device related Serious Adverse Events
Rate of participants treated with the Connected Catheter reported with a serious device related adverse event
Time frame: 0 - 40 days
Successful device insertion, anchoring, and removal
Rate of Connected Catheter successfully inserted, anchored and removed
Time frame: 35-40 days
Successful sealing of the catheter valve
Rate of Connected Catheter valves sealed successfully
Time frame: 35-40 days
Quality of life improvement as measured by SCI-QOL Survey and other surveys
Rate of participants treated with the Connected Catheter with improved overall quality of life as measured by the SCI-QOL Survey and other surveys
Time frame: 35-40 days
UTI occurrence rate
Rate of participants treated with the Connected Catheter reported with a urinary tract infection
Time frame: 35-40 days
Lower Urinary Tract injury rate
Rate of participants treated with the Connected Catheter that experience a lower urinary tract injury
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Chesapeake Urology
Owings Mills, Maryland, United States
Minnesota Urology, 6025 Lake Road Suite 200
Woodbury, Minnesota, United States
New Jersey Urology, 15000 Midlantic Drive, Suite 100
Mount Laurel, New Jersey, United States
New Jersey Urology, 2401 Evesham Road, Suite F
Voorhees Township, New Jersey, United States
Dr. Jonathan Vapnek Urology
New York, New York, United States
Urology San Antonio
San Antonio, Texas, United States
Time frame: 35-40 days