Urinary RetentionNCT03843073
Connected Catheter- Safety and Effectiveness Study
A study testing Connected Urinary Catheter in people with Urinary Retention and Neurogenic Bladder, run by Spinal Singularity at 9 sites in United States.
Trial summary
The Connected Catheter is a fully internal, urethral indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization. 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, Urologic Diseases
- What is being tested?
- Connected Urinary Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 9 sitesUnited States
- Study dates
- 16 Oct 2020to 6 Apr 2021
- 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 significant urinary retention
- Must be clinically suitable and capable of safely managing bladder using an intermittent voiding or indwelling strategy
- Must have stable urinary management history as determined by the Investigator
- OR:
- Must have urodynamic profile suitable for the Gen 2 Connected Catheter (including bladder capacity > 200mL without uninhibited bladder contractions)
- Subject's lower urinary tract anatomy must fall within the ranges serviceable by the Gen 2 Connected Catheter device, as specified in the Investigational Device Instructions for use (IFU)
Who cannot join
- Active symptomatic urinary tract infection (UTI), as defined in this protocol (subjects may receive the 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 (uncontrolled) autonomic dysreflexia (AD)
- Significant intermittent urinary incontinence (between catheterizations)
- Uninhibited bladder contractions and/or Vesicoureteral 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 18Show 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 Connected Catheter System
- Catheter Assessment Tool screening yields unacceptable results
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 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
Dr. Jonathan Vapnek Urology
New York, New York, 10075
Chesapeake Urology
Owings Mills, Maryland, 21117
Urology San Antonio
San Antonio, Texas, 78229
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: Evaluation of the Safety and Clinical Performance of the Gen 2 Connected Catheter - Wireless Urinary Prosthesis for Management of Chronic Urinary Retention
The Connected Catheter is a fully internal, urethral indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization. It is a sterile, extended-use device that resides fully internally to the male lower urinary tract for an intended use life of up to 7 days per catheter.
Read the detailed description
Spinal Singularity has developed the Connected Catheter System to address several drawbacks of urinary catheters. The Connected Catheter is fully internal, indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization. Each subject will use the Connected Catheter for up to 35-40 days. This includes five device exchange appointments. The appointments are spaced 7 days apart and at each appointment the catheter will be replaced with a new one. Additionally, weekly follow-up will occur for 14 days following the final appointment after the subject discontinues use of study device and reverts to his original catheter.
- Conditions
- Urinary Retention, Neurogenic Bladder, Urologic Diseases
- Being tested
- Connected Urinary Catheter
- Keywords
- Spinal Cord Injury (SCI),, Neurogenic Lower Urinary Tract Dysfunction (NLUTD), Catheter associated Urinary Tract Infection (CAUTI), Urinary Catheters, Urinary Retention, Enlarged Prostate, Prostate cancer
- Medical subject headings
- Urinary Retention, Urinary Bladder, Neurogenic, Urologic Diseases, Spinal Cord Injuries, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connected Urinary CatheterDevice
Patients will use the Connected Catheter to empty the bladder during the course of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Connected Catheter Users | Experimental | Not described Receives: Device: Connected Urinary Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Bladder Emptying Using Connected Catheter
Rate of participants with successful voiding using the Connected Catheter as assessed by Post-Residual Volume (PVR) measurement via ultrasound
A subject is considered a responder to the treatment if a minimum of 80% of their PVR values met the following criteria
PVR is ≤ 50 mL OR PVR is ≤ baseline PVR with the standard of care catheter
Measured: 35-40 days
Rate of device related Serious Adverse Events
Rate of participants treated with the Connected Catheter reported with a serious device related adverse event
Measured: 0 - 40 days
Secondary outcomes (5)
Successful device insertion, anchoring, and removal
Rate of Connected Catheter successfully inserted, anchored and removed
Measured: 35-40 days
Successful sealing of the catheter valve
Rate of Connected Catheter valves sealed successfully
Measured: 35-40 days
Quality of life improvement as measured by SCI-QOL Survey and other surveys
Rate of participants treated with the Connected Catheter with improved overall quality of life as measured by the SCI-QOL Survey and other surveys
Measured: 35-40 days
UTI occurrence rate
Rate of participants treated with the Connected Catheter reported with a urinary tract infection
Measured: 35-40 days
Lower Urinary Tract injury rate
Rate of participants treated with the Connected Catheter that experience a lower urinary tract injury
Measured: 35-40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start16 Oct 2020
- Primary completion23 Mar 2021
- Study completion6 Apr 2021
Why it stopped: The investigation of this device has been transitioned into a new study by the sponsor. The data generated in this study will not be used to support a marketing application
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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spinal Singularity
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843073
- Sponsor's protocol ID
- CIP-0001 (Formerly ES-01)
- Status last verified
- Nov 2021
- First submitted
- 7 Feb 2019
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Clinical Performance of the Gen 2 Connected Catheter - Wireless Urinary Prosthesis for Management of Chronic Urinary Retention
- ClinicalTrials.gov ID
- NCT03843073
- Acronym / sponsor ID
- CIP-0001 (Formerly ES-01)
- Conditions
- Urinary Retention, Neurogenic Bladder, Urologic Diseases
- Keywords
- Spinal Cord Injury (SCI),, Neurogenic Lower Urinary Tract Dysfunction (NLUTD), Catheter associated Urinary Tract Infection (CAUTI), Urinary Catheters, Urinary Retention, Enlarged Prostate, Prostate cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The investigation of this device has been transitioned into a new study by the sponsor. The data generated in this study will not be used to support a marketing application
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Spinal SingularityIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 23 Mar 2021 (actual)
- Study completion
- 6 Apr 2021 (actual)
- First posted
- 15 Feb 2019 (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 Connected Catheter is a fully internal, urethral indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization. It is a sterile, extended-use device that resides fully internally to the male lower urinary tract for an intended use life of up to 7 days per catheter.
Detailed description
Spinal Singularity has developed the Connected Catheter System to address several drawbacks of urinary catheters. The Connected Catheter is fully internal, indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization. Each subject will use the Connected Catheter for up to 35-40 days. This includes five device exchange appointments. The appointments are spaced 7 days apart and at each appointment the catheter will be replaced with a new one. Additionally, weekly follow-up will occur for 14 days following the final appointment after the subject discontinues use of study device and reverts to his original 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 |
|---|---|---|
| Connected Catheter Users | Experimental | Device: Connected Urinary Catheter |
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 significant urinary retention
- Must be clinically suitable and capable of safely managing bladder using an intermittent voiding or indwelling strategy
- Must have stable urinary management history as determined by the Investigator
- Must have urodynamic profile suitable for the Gen 2 Connected Catheter (including bladder capacity > 200mL without uninhibited bladder contractions)
- Subject's lower urinary tract anatomy must fall within the ranges serviceable by the Gen 2 Connected Catheter device, as specified in the Investigational Device Instructions for use (IFU)
Key exclusion criteria (18 listed)
- Active symptomatic urinary tract infection (UTI), as defined in this protocol (subjects may receive the 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 (uncontrolled) autonomic dysreflexia (AD)
- Significant intermittent urinary incontinence (between catheterizations)
- Uninhibited bladder contractions and/or Vesicoureteral 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 |
|---|---|---|
| Connected Urinary CatheterPatients will use the Connected Catheter to empty the bladder during the course of treatment. | Device | Connected Catheter Users |
Primary outcome
Successful Bladder Emptying Using Connected Catheter
Time frame: 35-40 days
Rate of participants with successful voiding using the Connected Catheter as assessed by Post-Residual Volume (PVR) measurement via ultrasound A subject is considered a responder to the treatment if a minimum of 80% of their PVR values met the following criteria PVR is ≤ 50 mL OR PVR is ≤ baseline PVR with the standard of care catheter
Rate of device related Serious Adverse Events
Time frame: 0 - 40 days
Rate of participants treated with the Connected Catheter reported with a serious device related adverse event
5 secondary outcomes
Successful device insertion, anchoring, and removal
Time frame: 35-40 days
Successful sealing of the catheter valve
Time frame: 35-40 days
Quality of life improvement as measured by SCI-QOL Survey and other surveys
Time frame: 35-40 days
UTI occurrence rate
Time frame: 35-40 days
Lower Urinary Tract injury rate
Time frame: 35-40 days
Results and safety
The study was stopped early (reason given: The investigation of this device has been transitioned into a new study by the sponsor. The data generated in this study will not be used to support a marketing application). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connected Urinary Catheter in people with Urinary Retention and Neurogenic Bladder, run by Spinal Singularity at 9 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 18 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: stopped early, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 was stopped early (reason given: The investigation of this device has been transitioned into a new study by the sponsor. The data generated in this study will not be used to support a marketing application). Results are not available in the source record.
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?
Successful Bladder Emptying Using Connected Catheter (time frame: 35-40 days). The study lists 2 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 23 Nov 2021.