Clinical trial NCT03626324: Connected Catheter (C2P) Study for Bladder Management
Official title: Clinical Evaluation of Connected Catheter 2P (C2P) Wireless Urinary Prosthesis for Management of Neurogenic Lower Urinary Tract Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Retention
Neurogenic Bladder
Keywords: Spinal Cord Injury (SCI)
Neurogenic Lower Urinary Tract Dysfunction (NLUTD)
Catheter associated Urinary Tract Infection (CAUTI)
Urinary Catheters
Dementia
Stroke
Diabetes
Parkinson's
Lead sponsor: Spinal Singularity
Sponsor class: INDUSTRY
First posted: 2018-08-13
Enrollment: 27
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 C2P System in males with neurogenic lower urinary tract dysfunction (NLUTD), both in an acute clinical setting and an extended period of home use.

Detailed description: Spinal Singularity had developed C2P system to address several drawbacks of current standard-of-care urinary catheters. The C2P is fully internal, urethral indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization, including NLUTD. The C2P is a sterile, single-extended use device that resides fully internally to the male lower urinary tract for an intended service life of up to 29 days per catheter

Eligibility criteria: Inclusion Criteria:

1. Males age ≥ 18 with clinical diagnosis of neurogenic lower urinary tract dysfunction (NLUTD)
2. 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)
3. 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).

Exclusion Criteria:

1. Active symptomatic urinary tract infection, as defined in this protocol (subjects may receive the device after Urinary Tract Infection (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 autonomic dysreflexia (AD) (e.g. History of hospitalization due to AD within past 12 months)
4. Significant intermittent urinary incontinence (between catheterizations)
5. Uninhibited bladder contractions and/or vesico-ureteral 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)
7. Urinary tract inflammation or neoplasm
8. Urinary fistula
9. Bladder diverticulum (outpouching) \> 5cm in size
10. Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past 6 months)
11. Impaired kidney function or renal failure
12. Active gross hematuria
13. Active urethritis
14. Bladder stones
15. Dependence on an electro-magnetic medical implant (e.g. cardiac pacemaker or implanted drug pump) or external device
16. Any unsuitable comorbidities as determined by the investigator or complications related to use of certain medications
17. Any physical or cognitive impairments that diminish the subject's ability to follow directions or otherwise safely use the C2P System

Primary outcomes:
measure: Freedom from genito-urinary injury/trauma
timeFrame: 3 months
measure: Successful Acute Performance- I
timeFrame: Day 0 (On the day of C2P insertion)
measure: Successful Acute Performance- II
timeFrame: Day 0 (On the day of C2P insertion)
measure: Successful Acute Performance- III
timeFrame: Day 0 (On the day of C2P insertion)
measure: Successful Home-use Performance
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Northwest Urology Associates, 9151 West Thunderbird Rd, Suite 104
state: Arizona
city: Surprise
country: United States
facility: Northwest Urology Associates, 14674 W. Mountain View Blvd, Suite 210
state: Arizona
city: Downey
country: United States
facility: West Coast Urology, 11411 Brookshire Avenue, Suite 508
state: California
city: Inglewood
country: United States
facility: West Coast Urology, 575 E. Hardy St., Suite 215
state: California
city: Murrieta
country: United States
facility: Tri Valley Urology, 25495 Medical Center Dr., Suite 204
state: California
city: Woodbury
country: United States
facility: Minnesota Urology, 6025 Lake Road Suite 200
state: Minnesota
city: Mount Laurel
country: United States
facility: New Jersey Urology, 15000 Midlantic Drive, Suite 100
state: New Jersey
city: Voorhees
country: United States
facility: New Jersey Urology, 2401 Evesham Road, Suite F
state: New Jersey
Study officials:
affiliation: Spinal Singularity
name: Derek Herrera
role: STUDY_DIRECTOR
References: