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
8
Patients will use the Connected Catheter to empty the bladder during the course of treatment.
Rancho Los Amigos Rehabiliation Hospital
Downey, California, United States
UC San Diego
San Diego, California, United States
MedStar National Rehabilitation Hospital
Washington D.C., District of Columbia, United States
Number of Participants With Device Related Serious Adverse Events
Rate of participants treated with the Connected Catheter reported with a serious device related adverse event
Time frame: 0 - 49 days
Number of Participants With UTI (Occurrence Rate)
Rate of participants treated with the Connected Catheter reported with a symptomatic urinary tract infection
Time frame: 0 - 49 days
Number of Participants With Lower Urinary Tract Injury
Rate of participants treated with the Connected Catheter that experience a lower urinary tract injury
Time frame: 0 - 40 days
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