Evaluation of the Safety and Clinical Performance of the Gen 2 Connected Catheter - Wireless Urinary Prosthesis for Management of Chronic Urinary Retention
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.
• Males age ≥ 18 with clinical diagnosis of significant urinary retention
• Must be clinically suitable and capable of safely managing bladder using an intermittent voiding or indwelling strategy
‣ Must have stable urinary management history as determined by the investigator OR:
⁃ Must have urodynamic profile suitable for Gen 2 Connected Catheter (including bladder capacity \> 200mL without uninhibited bladder contractions)
• Subject's lower urinary tract anatomy must fall within the ranges serviceable by the Gen 2 Connected Catheter device, as specified in the Investigational Device Instructions for Use (IFU).