NCT03626324

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 25, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 26, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 13, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

February 8, 2019

Status Verified

February 1, 2019

Enrollment Period

6 months

First QC Date

July 26, 2018

Last Update Submit

February 6, 2019

Conditions

Urinary RetentionNeurogenic Bladder

Keywords

Spinal Cord Injury (SCI)Neurogenic Lower Urinary Tract Dysfunction (NLUTD)Catheter associated Urinary Tract Infection (CAUTI)Urinary CathetersDementiaStrokeDiabetesParkinson's

Outcome Measures

Primary Outcomes (5)

  • Freedom from genito-urinary injury/trauma

    Improved bladder management without injury to genito-urinary tract

    3 months

  • Successful Acute Performance- I

    To evaluate successful retention of C2P

    Day 0 (On the day of C2P insertion)

  • Successful Acute Performance- II

    To evaluate successful bladder voiding with C2P

    Day 0 (On the day of C2P insertion)

  • Successful Acute Performance- III

    To evaluate successful valve sealing of C2P

    Day 0 (On the day of C2P insertion)

  • Successful Home-use Performance

    To evaluate successful home use of C2P using same measures as Acute Performance

    3 months

Study Arms (1)

C2P Study

EXPERIMENTAL

Clinical Evaluation of Connected Catheter 2P Urinary Prosthesis for Management of Neurogenic Lower Urinary Tract Dysfunction

Device: C2P

Interventions

C2PDEVICE

The C2P is a fully internal, urethral indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization, including neurogenic lower urinary tract dysfunction (NLUTD - e.g. due to spinal cord injury). The C2P is a sterile, single-extended-use device that resides fully internally to the male lower urinary tract (urethra + bladder neck) for an intended service life of up to 29 days per Catheter.

C2P Study

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Northwest Urology Associates, 9151 West Thunderbird Rd, Suite 104

Peoria, Arizona, 85351, United States

Location

Northwest Urology Associates, 14674 W. Mountain View Blvd, Suite 210

Surprise, Arizona, 85374, United States

Location

West Coast Urology, 11411 Brookshire Avenue, Suite 508

Downey, California, 90241, United States

Location

West Coast Urology, 575 E. Hardy St., Suite 215

Inglewood, California, 90301, United States

Location

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

Murrieta, California, 92562, United States

Location

Minnesota Urology, 6025 Lake Road Suite 200

Woodbury, Minnesota, 55125, United States

Location

New Jersey Urology, 15000 Midlantic Drive, Suite 100

Mount Laurel, New Jersey, 08054, United States

Location

New Jersey Urology, 2401 Evesham Road, Suite F

Voorhees Township, New Jersey, 08043, United States

Location

MeSH Terms

Conditions

Urinary RetentionUrinary Bladder, NeurogenicSpinal Cord InjuriesDementiaStrokeDiabetes MellitusParkinson Disease

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesNeurologic ManifestationsNervous System DiseasesUrinary Bladder DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal Cord DiseasesCentral Nervous System DiseasesTrauma, Nervous SystemWounds and InjuriesBrain DiseasesNeurocognitive DisordersMental DisordersCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Derek Herrera

    Spinal Singularity

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2018

First Posted

August 13, 2018

Study Start

July 25, 2018

Primary Completion

January 31, 2019

Study Completion

January 31, 2019

Last Updated

February 8, 2019

Record last verified: 2019-02

Locations

US(8)