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

 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

 1. Must have stable urinary management history as determined by the investigator OR:

 2. Must have urodynamic profile suitable for Gen 2 Connected Catheter (including
 bladder capacity > 200mL without uninhibited bladder contractions)

 3. 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).

 Exclusion Criteria:

 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)

 1. Urinary tract inflammation or neoplasm

 2. Urinary fistula

 3. Bladder diverticulum (outpouching) > 5cm in size

 4. Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past
 6 months)

 5. Impaired kidney function or renal failure

 6. Active gross hematuria

 7. Active urethritis