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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

NCT03843073•Spinal Singularity

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

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)
+8 more criteria

Locations (9)

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

Tri Valley Urology, 25495 Medical Center Dr., Suite 204

Murrieta, California, United States

Chesapeake Urology

Owings Mills, Maryland, United States

Minnesota Urology, 6025 Lake Road Suite 200

Woodbury, Minnesota, United States

New Jersey Urology, 15000 Midlantic Drive, Suite 100

Mount Laurel, New Jersey, United States

New Jersey Urology, 2401 Evesham Road, Suite F

Voorhees Township, New Jersey, United States

Dr. Jonathan Vapnek Urology

New York, New York, United States

Urology San Antonio

San Antonio, Texas, United States

Key Dates

Start Date

October 16, 2020

Primary Completion Date

March 23, 2021

Completion Date

April 6, 2021

Last Updated

November 23, 2021

Enrollment

ACTUAL participants

Conditions

Urinary RetentionNeurogenic BladderUrologic Diseases

Interventions

Connected Urinary Catheter

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 23, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Connected Catheter- Safety and Effectiveness Study

Inclusion Criteria

Exclusion Criteria

Impact of Tamsulosin on Post-Operative Urinary Retention Following Pelvic Reconstructive Surgery

Assess the Efficacy of OM-89 vs Placebo in Reducing Antibiotic Consumption Associated With the Treatment of Urinary Tract Infections in Patients With Neurogenic Bladder

Evaluation of AI Large Models for Diagnosis and Treatment in Real-World Cases: Multicenter Retrospective Study

Uroselective Alpha-1-Antagonist to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery

Intravesical Lactobacillus Crispatus: Clinical Safety and Microbiome Evaluation

The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)