Clinical trial NCT03405285: Connected Catheter Clinical Feasibility Study( CFS)
Official title: Clinical Evaluation of Connected Catheter Wireless Urinary Prosthesis for Management of Neurogenic Lower Urinary Tract Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Bladder, Neurogenic
Keywords: Improved Bladder Management
Neurogenic Lower Urinary Tract Dysfunction
Bladder function following Spinal Cord Injury
Urinary Retention
Lead sponsor: Spinal Singularity
Sponsor class: INDUSTRY
First posted: 2018-01-23
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to evaluate the safety and essential performance of the Connected Catheter System in males with neurogenic lower urinary tract dysfunction (NLUTD), both in an acute clinical setting, and during and extended period (up to 29 days) of home use.

Detailed description: The Connected Catheter (C2P) is a replaceable urinary prosthesis that is intended for use in male patients 18 years of age or older who have impaired bladder emptying due to neurogenic lower urinary tract dysfunction, and who are capable of operating the device in accordance with the provided instructions for use, or who have trained caregivers capable of doing the same. The device must be replaced every 29 days

Eligibility criteria: Inclusion Criteria:

* 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 strategy Must have stable urinary management history with clean intermittent catheterization: no significant changes in bladder management regimen within past 12 months

OR:

Must have urodynamic profile suitable for CIC, as assessed via urodynamics study within past 12 months (including bladder capacity \> 200mL without uninhibited bladder contractions)

* Subject's lower urinary tract anatomy (lengths of proximal and distal urethral must fall within the ranges serviceable by the Connected Catheter device, as specified in the investigational device instructions for use.
* For cases of NLUTD due to spinal cord injury, the subject must be in medically stable condition (i.e. post-spinal shock phase)

Exclusion Criteria:

* Active symptomatic urinary tract infection, as defined in this protocol (subjects may receive the CoCath 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 autonomic dysreflexia (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, urine analysis, and blood labs)
* 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 (assessed via blood creatinine levels \> 2 mg/dL)
* 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
* Individuals allergic or otherwise unable to take oral antibiotics
* Any physical or cognitive impairments that diminish the subject's ability to follow directions or otherwise safely use the CoCath System

Primary outcomes:
measure: Freedom from genito-urinary injury/trauma
timeFrame: 29 Days
measure: Successful Acute Performance- I
timeFrame: On the day of Connected Catheter Insertion
measure: Successful Acute Performance -II
timeFrame: On the day of Connected Catheter Insertion
measure: Successful Acute Performance- III
timeFrame: On the day of Connected Catheter Insertion
measure: Successful Acute Performance- IV
timeFrame: On the day of Connected Catheter Insertion
measure: Successful Home-Use Performance
timeFrame: 29 days
Secondary outcomes:
Other outcomes:
Locations:
city: Downey
country: United States
facility: West Coast Urology, 11411 Brookshire Avenue, Suite 508
state: California
city: Murrieta
country: United States
facility: Tri Valley Urology, 25495 Medical Center Dr., Suite 204
state: California
Study officials:
References: