Study Stopped
The investigation of this device has been transitioned into a new study by the sponsor. The data generated in this study will not be used to support a marketing application
Connected Catheter- Safety and Effectiveness Study
Evaluation of the Safety and Clinical Performance of the Gen 2 Connected Catheter - Wireless Urinary Prosthesis for Management of Chronic Urinary Retention
1 other identifier
interventional
9
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2020
Shorter than P25 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2019
CompletedFirst Posted
Study publicly available on registry
February 15, 2019
CompletedStudy Start
First participant enrolled
October 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 23, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 6, 2021
CompletedNovember 23, 2021
November 1, 2021
5 months
February 7, 2019
November 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (5)
Successful device insertion, anchoring, and removal
35-40 days
Successful sealing of the catheter valve
35-40 days
Quality of life improvement as measured by SCI-QOL Survey and other surveys
35-40 days
UTI occurrence rate
35-40 days
Lower Urinary Tract injury rate
35-40 days
Study Arms (1)
Connected Catheter Users
EXPERIMENTALInterventions
Patients will use the Connected Catheter to empty the bladder during the course of treatment.
Eligibility Criteria
You may qualify if:
- Males age ≥ 18 with clinical diagnosis of significant urinary retention
- 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)
- 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)
You may not qualify if:
- Active symptomatic urinary tract infection (UTI), as defined in this protocol (subjects may receive the device after 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 (AD)
- 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 injections)
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
West Coast Urology, 11411 Brookshire Avenue, Suite 508
Downey, California, 90241, United States
West Coast Urology, 575 E. Hardy St., Suite 215
Inglewood, California, 90301, United States
Tri Valley Urology, 25495 Medical Center Dr., Suite 204
Murrieta, California, 92562, United States
Chesapeake Urology
Owings Mills, Maryland, 21117, United States
Minnesota Urology, 6025 Lake Road Suite 200
Woodbury, Minnesota, 55125, United States
New Jersey Urology, 15000 Midlantic Drive, Suite 100
Mount Laurel, New Jersey, 08054, United States
New Jersey Urology, 2401 Evesham Road, Suite F
Voorhees Township, New Jersey, 08043, United States
Dr. Jonathan Vapnek Urology
New York, New York, 10075, United States
Urology San Antonio
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2019
First Posted
February 15, 2019
Study Start
October 16, 2020
Primary Completion
March 23, 2021
Study Completion
April 6, 2021
Last Updated
November 23, 2021
Record last verified: 2021-11