Summary

Eligibility
for males ages 22 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study start
estimated completion
Principal Investigator
by Yahir Santiago-Lasatra, MD
Headshot of Yahir Santiago-Lasatra
Yahir Santiago-Lasatra

Description

Summary

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.

Official Title

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

Details

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.

Keywords

Urinary Retention, Chronic, Intermittent Catheter, Intermittent catheterization, Impaired bladder, Connected Catheter

Eligibility

You can join if…

Open to males ages 22 years and up

    1. Males > 22 years old diagnosed with chronic Urinary Retention 2. Must be clinically suitable and capable of safely managing bladder using an intermittent voiding or indwelling catheter strategy:
    2. Must have stable urinary management history as determined by the Principal Investigator OR
    3. Must have urodynamic profile suitable for the 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 Connected Catheter device, as specified in the Investigational Device Instructions For Use.

You CAN'T join if...

    1. Active symptomatic urinary tract infection, as defined in this clinical investigation plan (CIP)/protocol (subjects may receive the device after their 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)
    2. Active symptomatic urinary tract infection, as defined in this clinical investigation plan (CIP)/protocol (subjects may receive the device after their UTI has been treated)
    3. Significant risk profile or recent history of urethral stricture (e.g., stricture within past 90 days)
    4. Significant risk profile or recent history of clinically significant (uncontrolled) autonomic dysreflexia
    5. Significant intermittent urinary incontinence (between catheterizations)
    6. Uninhibited bladder contractions and/or Vesicoureteral reflux that is not reliably controlled with medication or alternate therapy (e.g., Botox injection)
    7. 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
      8. Bladder stones
    8. Dependence on an electro-magnetic medical implant (e.g., cardiac pacemaker or implanted drug pump) or external device
    9. Any unsuitable comorbidities as determined by the Principal Investigator or complications related to use of certain medications
    10. Any physical or cognitive impairments that diminish the subject's ability to follow directions or otherwise safely use the Connected Catheter System
    11. Catheter Assessment Tool screening yields unacceptable results
    12. Vulnerable population such as inmates or developmentally delayed adults

Locations

  • UCSD accepting new patients
    San Diego California 92103 United States
  • Tri Valley Urology, 25495 Medical Center Dr., Suite 204 accepting new patients
    Murrieta California 92562 United States

Lead Scientist at UCSD

  • Yahir Santiago-Lasatra, MD
    Associate Clinical Professor, Urology, Vc-health Sciences-schools. Authored (or co-authored) 19 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Spinal Singularity
ID
NCT05330598
Study Type
Interventional
Participants
Expecting 90 study participants
Last Updated