Urinary Retention Clinical Trial
Official title:
Evaluation of the Safety and Clinical Performance of the Gen 2 Connected Catheter - Wireless Urinary Prosthesis for Management of Chronic Urinary Retention
Verified date | November 2021 |
Source | Spinal Singularity |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 9 |
Est. completion date | April 6, 2021 |
Est. primary completion date | March 23, 2021 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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 Must have stable urinary management history as determined by the Investigator OR: Must have urodynamic profile suitable for the 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 (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 (AD) 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 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) 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 7. Dependence on an electro-magnetic medical implant (e.g. cardiac pacemaker or implanted drug pump) or external device 8. Any unsuitable comorbidities as determined by the investigator or complications related to use of certain medications 9. Any physical or cognitive impairments that diminish the subject's ability to follow directions or otherwise safely use the Connected Catheter System 10. Catheter Assessment Tool screening yields unacceptable results |
Country | Name | City | State |
---|---|---|---|
United States | West Coast Urology, 11411 Brookshire Avenue, Suite 508 | Downey | California |
United States | West Coast Urology, 575 E. Hardy St., Suite 215 | Inglewood | California |
United States | New Jersey Urology, 15000 Midlantic Drive, Suite 100 | Mount Laurel | New Jersey |
United States | Tri Valley Urology, 25495 Medical Center Dr., Suite 204 | Murrieta | California |
United States | Dr. Jonathan Vapnek Urology | New York | New York |
United States | Chesapeake Urology | Owings Mills | Maryland |
United States | Urology San Antonio | San Antonio | Texas |
United States | New Jersey Urology, 2401 Evesham Road, Suite F | Voorhees | New Jersey |
United States | Minnesota Urology, 6025 Lake Road Suite 200 | Woodbury | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Spinal Singularity |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Successful Bladder Emptying Using Connected Catheter | Rate of participants with successful voiding using the Connected Catheter as assessed by Post-Residual Volume (PVR) measurement via ultrasound
A subject is considered a responder to the treatment if a minimum of 80% of their PVR values met the following criteria PVR is = 50 mL OR PVR is = baseline PVR with the standard of care catheter |
35-40 days | |
Primary | Rate of device related Serious Adverse Events | Rate of participants treated with the Connected Catheter reported with a serious device related adverse event | 0 - 40 days | |
Secondary | Successful device insertion, anchoring, and removal | Rate of Connected Catheter successfully inserted, anchored and removed | 35-40 days | |
Secondary | Successful sealing of the catheter valve | Rate of Connected Catheter valves sealed successfully | 35-40 days | |
Secondary | Quality of life improvement as measured by SCI-QOL Survey and other surveys | Rate of participants treated with the Connected Catheter with improved overall quality of life as measured by the SCI-QOL Survey and other surveys | 35-40 days | |
Secondary | UTI occurrence rate | Rate of participants treated with the Connected Catheter reported with a urinary tract infection | 35-40 days | |
Secondary | Lower Urinary Tract injury rate | Rate of participants treated with the Connected Catheter that experience a lower urinary tract injury | 35-40 days |
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