Summary

for males ages 18-90 (full criteria)
at San Diego, California and other locations
study started
estimated completion
Michael Albo, MDYahir Santiago-Lastra, MD

Description

Summary

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.

Details

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.

Keywords

Neurogenic Bladder Urinary Retention Urologic Diseases catheter Urinary Bladder, Neurogenic Connected Catheter Connected Catheter Users

Eligibility

You can join if…

Open to males ages 18-90

  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 Must have stable urinary management history as determined by the investigator

OR:

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

  1. Subject's lower urinary tract anatomy must fall within the ranges serviceable by the Connected Catheter, as specified in the Investigational Device Instructions for Use (IFU).

You CAN'T join if...

  1. Active symptomatic Urinary Tract Infection (UTI), as defined in this 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 incontinence (between catheterizations)
  5. Uninhibited bladder contractions and/or Vesicoureteral reflux that is not reliably controlled with medication or alternate therapy (e.g. Botox injections)
  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
  14. Bladder stones
  15. Dependence on an electro-magnetic medical implant (e.g. cardiac pacemaker or implanted drug pump) or external device
  16. Any unsuitable comorbidities as determined by the investigator or complications related to use of certain medications
  17. Any physical or cognitive impairments that diminish the subject's ability to follow directions or otherwise safely use the Connected Catheter System
  18. . Catheter Assessment Tool screening yields unacceptable results

Locations

  • UC San Diego not yet accepting patients
    San Diego California 92093 United States
  • Rancho Los Amigos Rehabiliation Hospital accepting new patients
    Downey California 90242 United States

Lead Scientists

  • Michael Albo, MD
    Dr. Michael Albo is a urologist specializing in voiding dysfunction, urinary incontinence, urodynamics, female urology, and pelvic floor reconstruction.
  • Yahir Santiago-Lastra, MD
    Assistant Clinical Professor, Urology. Authored (or co-authored) 11 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Spinal Singularity
ID
NCT04059159
Study Type
Interventional
Last Updated