Connected Catheter (C2P) Study for Bladder Management

Completed · Not applicable

Conditions studied: Urinary Retention, Neurogenic Bladder

In brief

The objective of this study is to evaluate the safety and essential performance of the C2P System in males with neurogenic lower urinary tract dysfunction (NLUTD), both in an acute clinical setting and an extended period of home use.

Key facts

Study ID

NCT03626324

Run by

Spinal Singularity

People needed

27

Starts

2018-07-25

Expected to finish

2019-01-31

Last updated by the study team

2019-02-08

Who can join

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

You may qualify if…

• Males age ≥ 18 with clinical diagnosis of neurogenic lower urinary tract dysfunction (NLUTD)
• Must be clinically suitable and capable of safely managing bladder using an intermittent voiding or indwelling strategy
• Must have stable urinary management history: no significant changes in bladder management regimen within past 12 months
• OR:
• Must have urodynamic profile suitable for C2P, as assessed via urodynamics study within past 12 months (including bladder capacity > 200mL without uninhibited bladder contractions)
• Subject's lower urinary tract anatomy must fall within the ranges serviceable by the C2P 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 protocol (subjects may receive the device after Urinary Tract Infection (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 autonomic dysreflexia (AD) (e.g. History of hospitalization due to AD within past 12 months)
• Significant intermittent urinary incontinence (between catheterizations)
• Uninhibited bladder contractions and/or vesico-ureteral 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
• 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 C2P System

Where it is running

• Northwest Urology Associates, 9151 West Thunderbird Rd, Suite 104 — Peoria, Arizona, United States
• Northwest Urology Associates, 14674 W. Mountain View Blvd, Suite 210 — Surprise, Arizona, United States
• 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
• 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

Full record on ClinicalTrials.gov

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