Connected Catheter - Safety and Effectiveness Study

Stopped early · Not applicable

Conditions studied: Neurogenic Bladder, Urinary Retention, Urologic Diseases

In brief

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.

Key facts

Study ID

NCT04059159

Run by

Spinal Singularity

People needed

8

Starts

2020-10-01

Expected to finish

2021-04-07

Last updated by the study team

2023-01-20

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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 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, as defined in this clinical investigation 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
• 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 injection)
• 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
• Dependence on an electro-magnetic medical implant (e.g. cardiac pacemaker or implanted drug pump) or external device
• Any unsuitable comorbidities as determined by the Investigator or complications related to use of certain medications
• Any physical or cognitive impairments that diminish the subject's ability to follow directions or otherwise safely use the Gen 2 Connected Catheter System
• Catheter Assessment Tool screening yields unacceptable results

Where it is running

• Rancho Los Amigos Rehabiliation Hospital — Downey, California, United States
• UC San Diego — San Diego, California, United States
• MedStar National Rehabilitation Hospital — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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