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

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ClinicalTrials.gov Identifier: NCT04059159
Recruitment Status : Not yet recruiting
First Posted : August 16, 2019
Last Update Posted : August 16, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Spinal Singularity

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
Neurogenic Bladder Urinary Retention Urologic Diseases Device: Connected 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Clinical Evaluation of the Connected Catheter - Wireless Urinary Prosthesis for Management of Chronic Urinary Retention
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

Arm Intervention/treatment
Experimental: Connected Catheter Users Device: Connected Catheter
Patients will use the Connected Catheter to empty the bladder during the course of treatment.




Primary Outcome Measures :
  1. Improved bladder management without injury to genito-urinary tract [ Time Frame: 35-40 days ]
    Absence of genito-urinary injury/trauma when using Connected Catheter

  2. Successful Bladder Emptying Using Connected Catheter [ Time Frame: 35-40 days ]
    Successful voiding with Connected Catheter as assessed by Post-Residual Volume (PVR) measurement via ultrasound

  3. Freedom from Symptomatic Urinary Tract Infection (UTI) [ Time Frame: 35-40 days ]
    Successful use of the Connected Catheter without significant increase in UTI.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Device is currently only designed for use by males.
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 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, 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
  4. Significant intermittent 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

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): NCT04059159


Contacts
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Contact: Bill Colone 949-436-7974 bill@spinalsingularity.com
Contact: Shannon Metzger 949-436-7974

Locations
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United States, California
Rancho Los Amigos Rehabiliation Hospital Not yet recruiting
Downey, California, United States, 90242
Contact: Sandra Avina    562-385-7048    savina@ranchoresearch.org   
Principal Investigator: Evgeniy Kreydin, MD         
Principal Investigator: David Ginsberg, MD         
UC San Diego Not yet recruiting
San Diego, California, United States, 92093
Contact: Archana Bhatt    858-822-2661    abhatt@ucsd.edu   
Principal Investigator: Michael Albo, MD         
Principal Investigator: Yahir Santiago-Lastra, MD         
United States, District of Columbia
MedStar National Rehabilitation Hospital Not yet recruiting
Washington, District of Columbia, United States, 20010
Contact: Amanda Rounds    202-877-1694    Amanda.K.Rounds@medstar.net   
Principal Investigator: Suzanne Groah, MD         
Principal Investigator: Krishnan Venkatesan, MD         
Sponsors and Collaborators
Spinal Singularity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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Responsible Party: Spinal Singularity
ClinicalTrials.gov Identifier: NCT04059159     History of Changes
Other Study ID Numbers: ES-NIH-01
First Posted: August 16, 2019    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Spinal Singularity:
catheter
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
Signs and Symptoms