The objective of this study is to evaluate the safety and effectiveness of the Connected Catheter in males with chronic Urinary Retention, both in a clinical setting and an extended period of home use. 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.
UroDev Medical 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 4 weeks including weekly device exchange appointments. 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
TREATMENT
Masking
NONE
Enrollment
26
The Connected Catheter System is a replaceable wireless urinary prosthesis that is indicated for bladder emptying in male patients who have impaired bladder emptying due to chronic Urinary Retention. The Connected Catheter resides fully internally in the male lower urinary tract (urethra and bladder neck) and remains in place for up to 7 days before removal.
Rancho Research Institute
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
UCSD
San Diego, California, United States
Successful Bladder Emptying Using Connected Catheter
PVR Responder Rate, defined as either: * Less than or equal to 50mL OR * Equal to or less than their baseline PVR when using SOC catheters The subject responder rate, R, is estimated as the proportion of subjects who are classified as responders.
Time frame: 4 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Medstar National Rehabilitation Hospital
Washington D.C., District of Columbia, United States