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Connected Catheter- Safety and Effectiveness Study

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ClinicalTrials.gov Identifier: NCT03843073
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : December 31, 2020
Sponsor:
Information provided by (Responsible Party):
Spinal Singularity

Study Description
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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.

Condition or disease Intervention/treatment Phase
Urinary Retention Neurogenic Bladder Urologic Diseases Device: Connected Urinary Catheter Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Safety and Clinical Performance of the Gen 2 Connected Catheter - Wireless Urinary Prosthesis for Management of Chronic Urinary Retention
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : August 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Connected Catheter Users Device: Connected Urinary Catheter
Patients will use the Connected Catheter to empty the bladder during the course of treatment.


Outcome Measures
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Primary Outcome Measures :
  1. Successful Bladder Emptying Using Connected Catheter [ Time Frame: 35-40 days ]

    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


  2. Rate of device related Serious Adverse Events [ Time Frame: 0 - 40 days ]
    Rate of participants treated with the Connected Catheter reported with a serious device related adverse event


Secondary Outcome Measures :
  1. Successful device insertion, anchoring, and removal [ Time Frame: 35-40 days ]
    Rate of Connected Catheter successfully inserted, anchored and removed

  2. Successful sealing of the catheter valve [ Time Frame: 35-40 days ]
    Rate of Connected Catheter valves sealed successfully

  3. Quality of life improvement as measured by SCI-QOL Survey and other surveys [ Time Frame: 35-40 days ]
    Rate of participants treated with the Connected Catheter with improved overall quality of life as measured by the SCI-QOL Survey and other surveys

  4. UTI occurrence rate [ Time Frame: 35-40 days ]
    Rate of participants treated with the Connected Catheter reported with a urinary tract infection

  5. Lower Urinary Tract injury rate [ Time Frame: 35-40 days ]
    Rate of participants treated with the Connected Catheter that experience a lower urinary tract injury


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03843073


Contacts
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Contact: Shannon Metzger 949-436-7974 shannon@spinalsingularity.com

Locations
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United States, California
West Coast Urology, 11411 Brookshire Avenue, Suite 508 Recruiting
Downey, California, United States, 90241
Contact: Tiffany Aynehchi    562-923-0706    tiffany@westcoasturology.com   
Principal Investigator: Ernest Agatstein, MD         
West Coast Urology, 575 E. Hardy St., Suite 215 Recruiting
Inglewood, California, United States, 90301
Contact: Tiffany Aynehchi    562-923-0706    tiffany@westcoasturology.com   
Principal Investigator: Ernest Agatstein, MD         
Tri Valley Urology, 25495 Medical Center Dr., Suite 204 Recruiting
Murrieta, California, United States, 92562
Contact: Anita Deeds    951-698-1901 ext 232    anita@trivalleyurology.com   
Principal Investigator: Sreenivas Vemulapalli, MD         
United States, Maryland
Chesapeake Urology Recruiting
Owings Mills, Maryland, United States, 21117
Contact: Rayna Bennett-Campbell    443-231-1203    rbennett@chesuro.com   
Principal Investigator: Andrew Shapiro, MD         
United States, Minnesota
Minnesota Urology, 6025 Lake Road Suite 200 Recruiting
Woodbury, Minnesota, United States, 55125
Contact: Diane Kachel    651-999-7032    DKachel@mnurology.com   
Principal Investigator: Steven Siegel, MD         
United States, New Jersey
New Jersey Urology, 15000 Midlantic Drive, Suite 100 Recruiting
Mount Laurel, New Jersey, United States, 08054
Contact: Jennifer Pilallis    856-673-1613    jpilallis@dvullc.com   
Principal Investigator: Thomas Mueller, MD         
New Jersey Urology, 2401 Evesham Road, Suite F Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Renee Haney    856-673-1613    rhaney@dvullc.com   
Principal Investigator: Thomas Mueller, MD         
United States, New York
Dr. Jonathan Vapnek Urology Recruiting
New York, New York, United States, 10075
Contact: Jonathan Vapnek, MD    212-717-9500    jvapnek@rcn.com   
United States, Texas
Urology San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Kethsaly Salinas    210-617-4116    kethsaly.salinas@urologysa.com   
Principal Investigator: David Talley, MD         
Sponsors and Collaborators
Spinal Singularity
More Information
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Responsible Party: Spinal Singularity
ClinicalTrials.gov Identifier: NCT03843073    
Other Study ID Numbers: CIP-0001 (Formerly ES-01)
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: December 31, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Spinal Singularity:
Spinal Cord Injury (SCI),
Neurogenic Lower Urinary Tract Dysfunction (NLUTD)
Catheter associated Urinary Tract Infection (CAUTI)
Urinary Catheters
 Urinary Retention
Enlarged Prostate
Prostate cancer
Additional relevant MeSH terms:
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Urinary Bladder, Neurogenic
Urinary Retention
Urologic Diseases
Urination Disorders
 Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases