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CompletedNCT03626324Updated Feb 8, 2019

Connected Catheter (C2P) Study for Bladder Management

An interventional study of C2P in Urinary Retention and Neurogenic Bladder, sponsored by Spinal Singularity. Completed at 8 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-08.

Sponsored by Spinal Singularity · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 98 studies in Urinary Retention with a site in United States — 13 open to participants now, 18 under way, 1 of them phase 3. Urinary Retention · United States.

Enrollment
61st of 81
27 · median 88
Started
2018
with 7 others
No phase
53 of 98
6 open now
Registered
51st of 98
by date
Lead sponsor
5 of 98
Spinal Singularity

Among the 98 studies in Urinary Retention with a site in United States, this one is the 61st largest by enrollment of the 81 interventional ones, is one of 8 that started in 2018, is one of 53 with no phase, and was the 51st registered.

By phase

98 studies; the count open now beside each. This study's row is marked.

No phasethis study53 · 6 open
Observational17 · 2 open
Phase 411 · 1 open
Phase 38 · 1 open
Phase 13 · 1 open
Phase 23 · 1 open
Phase 1/22 · 1 open
Phase 2/31 · 0 open

By the year they started

First in 2001; this study’s year is marked. 8 started in 2018.

Size and results

Median enrollment 88 across the 81 interventional studies, 90 across the 17 observational. Of the 69 that completed or were terminated, 35 (51%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 98 studies in Urinary Retention with a site in United States, or all of them as a file.
02

Study 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.

Read the 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

03

Conditions studied

  • 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
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 device instructions for use (IFU).

Exclusion criteria

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 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    C2P Study

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

    Device: C2P

Interventions

  • DeviceC2P

    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.

06

What researchers measure

Primary outcomes

  1. Freedom from genito-urinary injury/trauma

    Improved bladder management without injury to genito-urinary tract

    Time frame: 3 months

  2. Successful Acute Performance- I

    To evaluate successful retention of C2P

    Time frame: Day 0 (On the day of C2P insertion)

  3. Successful Acute Performance- II

    To evaluate successful bladder voiding with C2P

    Time frame: Day 0 (On the day of C2P insertion)

  4. Successful Acute Performance- III

    To evaluate successful valve sealing of C2P

    Time frame: Day 0 (On the day of C2P insertion)

  5. Successful Home-use Performance

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

    Time frame: 3 months

07

Study locations

8 sites
  • Northwest Urology Associates, 9151 West Thunderbird Rd, Suite 104
    Peoria, Arizona 85351, United States
  • Northwest Urology Associates, 14674 W. Mountain View Blvd, Suite 210
    Surprise, Arizona 85374, United States
  • West Coast Urology, 11411 Brookshire Avenue, Suite 508
    Downey, California 90241, United States
  • West Coast Urology, 575 E. Hardy St., Suite 215
    Inglewood, California 90301, United States
  • Tri Valley Urology, 25495 Medical Center Dr., Suite 204
    Murrieta, California 92562, United States
  • Minnesota Urology, 6025 Lake Road Suite 200
    Woodbury, Minnesota 55125, United States
  • New Jersey Urology, 15000 Midlantic Drive, Suite 100
    Mount Laurel, New Jersey 08054, United States
  • New Jersey Urology, 2401 Evesham Road, Suite F
    Voorhees, New Jersey 08043, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2018 to primary completion in Jan 2019, 6 months.

Of 82 interventional studies with no phase under Urinary Retention, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 37. This study's 6 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 26, 2018
First posted
Aug 13, 2018
StartActual
Jul 25, 2018
Primary completionActual
Jan 31, 2019
CompletionActual
Jan 31, 2019
Last update
Feb 8, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03626324
Lead sponsor
Spinal Singularity
Responsible party
Sponsor
First posted
Aug 13, 2018
Start date
Jul 25, 2018
Primary completion
Jan 31, 2019
Completion
Jan 31, 2019
Last update
Feb 8, 2019

Study contacts

Derek Herrera
study director · Spinal Singularity

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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