Evaluation of the Safety and Clinical Performance of the Gen 2 Connected Catheter - Wireless Urinary Prosthesis for Management of Chronic Urinary Retention

Open to males ages 18 years and up

1. Males age ≥ 18 with clinical diagnosis of significant urinary retention
2. Must be clinically suitable and capable of safely managing bladder using an intermittent voiding or indwelling strategy
3. Must have stable urinary management history as determined by the investigator OR:
4. Must have urodynamic profile suitable for Gen 2 Connected Catheter (including bladder capacity > 200mL without uninhibited bladder contractions)
5. 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).

1. Active symptomatic urinary tract infection, as defined in this clinical investigation protocol (subjects may receive the device after UTI has been treated)
2. Significant risk profile or recent history of urethral stricture (e.g. stricture within past 90 days)
3. Significant risk profile or recent history of clinically significant (uncontrolled) autonomic dysreflexia
4. Significant intermittent urinary incontinence (between catheterizations)
5. Uninhibited bladder contractions and/or Vesicoureteral reflux that is not reliably controlled with medication or alternate therapy (e.g. Botox injection)
6. Pre-existing urinary pathologies and/or morphological abnormalities of the lower urinary tract or bladder (assessed during in-depth medical screening, including cystoscopy and urine analysis)
7. Urinary tract inflammation or neoplasm
8. Urinary fistula
9. Bladder diverticulum (outpouching) > 5cm in size
10. Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past 6 months)
11. Impaired kidney function or renal failure
12. Active gross hematuria
13. Active urethritis