Urinary RetentionNCT03626324
Connected Catheter (C2P) Study for Bladder Management
A study testing C2P in people with Urinary Retention and Neurogenic Bladder, run by Spinal Singularity at 8 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Retention, Neurogenic Bladder
- What is being tested?
- C2P
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 8 sitesUnited States
- Study dates
- 25 Jul 2018to 31 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
West Coast Urology, 11411 Brookshire Avenue, Suite 508
Downey, California, 90241
West Coast Urology, 575 E. Hardy St., Suite 215
Inglewood, California, 90301
New Jersey Urology, 15000 Midlantic Drive, Suite 100
Mount Laurel, New Jersey, 08054
Tri Valley Urology, 25495 Medical Center Dr., Suite 204
Murrieta, California, 92562
Northwest Urology Associates, 9151 West Thunderbird Rd, Suite 104
Peoria, Arizona, 85351
Northwest Urology Associates, 14674 W. Mountain View Blvd, Suite 210
Surprise, Arizona, 85374
New Jersey Urology, 2401 Evesham Road, Suite F
Voorhees Township, New Jersey, 08043
Minnesota Urology, 6025 Lake Road Suite 200
Woodbury, Minnesota, 55125
About this study
Official title: Clinical Evaluation of Connected Catheter 2P (C2P) Wireless Urinary Prosthesis for Management of Neurogenic Lower Urinary Tract Dysfunction
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
- Conditions
- Urinary Retention, Neurogenic Bladder
- Being tested
- C2P
- Keywords
- Spinal Cord Injury (SCI), Neurogenic Lower Urinary Tract Dysfunction (NLUTD), Catheter associated Urinary Tract Infection (CAUTI), Urinary Catheters, Dementia, Stroke, Diabetes, Parkinson's
- Medical subject headings
- Urinary Retention, Urinary Bladder, Neurogenic, Spinal Cord Injuries, Dementia, Stroke, Diabetes Mellitus, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| C2P Study | Experimental | Clinical Evaluation of Connected Catheter 2P Urinary Prosthesis for Management of Neurogenic Lower Urinary Tract Dysfunction Receives: Device: C2P |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from genito-urinary injury/trauma
Improved bladder management without injury to genito-urinary tract
Measured: 3 months
Successful Acute Performance- I
To evaluate successful retention of C2P
Measured: Day 0 (On the day of C2P insertion)
Successful Acute Performance- II
To evaluate successful bladder voiding with C2P
Measured: Day 0 (On the day of C2P insertion)
Successful Acute Performance- III
To evaluate successful valve sealing of C2P
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start25 Jul 2018
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary RetentionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spinal Singularity
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Derek Herrera, Study director, Spinal Singularity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626324
- Sponsor's protocol ID
- C2P-01
- Status last verified
- Feb 2019
- First submitted
- 26 Jul 2018
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Connected Catheter 2P (C2P) Wireless Urinary Prosthesis for Management of Neurogenic Lower Urinary Tract Dysfunction
- ClinicalTrials.gov ID
- NCT03626324
- Acronym / sponsor ID
- C2P-01
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Spinal SingularityIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 13 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C2P Study | Experimental | Device: C2PClinical Evaluation of Connected Catheter 2P Urinary Prosthesis for Management of Neurogenic Lower Urinary Tract Dysfunction |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- 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).
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C2PThe 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. | Device | C2P Study |
Primary outcome
Freedom from genito-urinary injury/trauma
Time frame: 3 months
Improved bladder management without injury to genito-urinary tract
Successful Acute Performance- I
Time frame: Day 0 (On the day of C2P insertion)
To evaluate successful retention of C2P
Successful Acute Performance- II
Time frame: Day 0 (On the day of C2P insertion)
To evaluate successful bladder voiding with C2P
Successful Acute Performance- III
Time frame: Day 0 (On the day of C2P insertion)
To evaluate successful valve sealing of C2P
Successful Home-use Performance
Time frame: 3 months
To evaluate successful home use of C2P using same measures as Acute Performance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derek Herrera study director
Spinal Singularity
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C2P in people with Urinary Retention and Neurogenic Bladder, run by Spinal Singularity at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from genito-urinary injury/trauma (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.