Status:
TERMINATED
Evaluation of the Safety and Clinical Performance of the Connected Catheter Study
Lead Sponsor:
Spinal Singularity
Conditions:
Urinary Retention
Chronic
Eligibility:
MALE
22+ years
Phase:
NA
Brief 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...
Detailed Description
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 impro...
Eligibility Criteria
Inclusion
- 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:
- Must have stable urinary management history as determined by the Principal Investigator OR
- 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.
Exclusion
- 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)
- 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)
- Significant risk profile or recent history of urethral stricture (e.g., stricture within past 90 days)
- Significant risk profile or recent history of clinically significant (uncontrolled) autonomic dysreflexia
- Significant intermittent urinary incontinence (between catheterizations)
- Uninhibited bladder contractions and/or Vesicoureteral reflux that is not reliably controlled with medication or alternate therapy (e.g., Botox injection)
- 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)
- Urinary tract inflammation or neoplasm
- Urinary fistula
- Bladder diverticulum (outpouching) \> 5cm in size
- Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past 6 months)
- Impaired kidney function or renal failure
- Active gross hematuria
- Active urethritis
- Bladder stones
- Dependence on an electro-magnetic medical implant (e.g., cardiac pacemaker or implanted drug pump) or external device
- Any unsuitable comorbidities as determined by the Principal Investigator or complications related to use of certain medications
- Any physical or cognitive impairments that diminish the subject's ability to follow directions or otherwise safely use the Connected Catheter System
- Catheter Assessment Tool screening yields unacceptable results
- Vulnerable population such as inmates or developmentally delayed adults
Key Trial Info
Start Date :
January 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2024
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT05330598
Start Date
January 27 2022
End Date
February 1 2024
Last Update
February 26 2024
Active Locations (5)
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1
Rancho Research Institute
Downey, California, United States, 90242
2
West Coast Urology, 575 E. Hardy St., Suite 215
Inglewood, California, United States, 90301
3
Tri Valley Urology, 25495 Medical Center Dr., Suite 204
Murrieta, California, United States, 92562
4
UCSD
San Diego, California, United States, 92103