Urinary RetentionNCT03353571
A Prospective Evaluation of the Catheter Science C3 "Umbrella Catheter."
A study testing C3 "UMBRELLA CATHETER" in people with Urinary Retention and Urinary Bladder, Neurogenic, run by Dr. Gaines W. Hammond Jr. MD FACS at 1 site in United States.
Trial summary
The Catheter Science C3 "Umbrella Catheter" has been developed for management of urinary retention in patients who are either using a Foley or Self Intermittent Catheter. This device is inserted into the bladder in an extended state and once the stylet is removed the device folds into collapsed state. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Retention, Urinary Bladder, Neurogenic, Intermittent Catheterization
- What is being tested?
- C3 "UMBRELLA CATHETER"
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2017to Mar 2018
- 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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with Bladder Dysfunction requiring mechanical drainage.
- Patients with actual urinary retention
Who cannot join
- Inability to undergo bladder catheterization (e.g., urethral stricture or history of urethral stricture)
- Gross hematuria
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Watson Clinic Llp
Lakeland, Florida, 33805
GAINES W HAMMOND, MD, 863-680-7300, GHAMMOND@WATSONCLINIC.COM
ELAYNE HALL, 863-680-7300, EHALL@WATSONCLINIC.COM
About this study
Official title: A Prospective Evaluation of the Catheter Science C3 "Umbrella Catheter" for Patients With Urinary Retention Due to Bladder Dysfunction (C3 Catheter Study)
The Catheter Science C3 "Umbrella Catheter" has been developed for management of urinary retention in patients who are either using a Foley or Self Intermittent Catheter. This device is inserted into the bladder in an extended state and once the stylet is removed the device folds into collapsed state. A thread is attached to the device and traverses thru the urethra and is attached to a bobber. With gentle traction on the thread the device engages the bladder neck and the central tube extends which allows for the flow of urine. Once voiding is complete, the thread is released and the device collapses back to the folded state into the bladder. Each voiding cycle is accomplished in a similar fashion. This is a novel technique in which the bladder is catheterized with the device from within the bladder into the bladder neck and urethra. The standard self catheter technique is for placement of a catheter from the outside into the urethra and into the bladder.
Read the detailed description
Interventional (clinical trial): Participants are assigned prospectively to an intervention or interventions according to a protocol to evaluate the effect of the intervention(s) on biomedical or other health related outcomes.
This single arm, prospective study is designed to produce valid scientific evidence regarding:
- Safety and efficacy of the Catheter Science C3 "Umbrella Catheter" in establishing urinary drainage and allowing the control of micturition when indwelling for up to 7 days.
- The reduction in Catheter Acquired Urinary Tract Infection (CAUTI)
A single arm study design was chosen because there is no alternative treatment to serve as an appropriate control. The C3 catheterizes the bladder with engagement into the bladder neck under the control of the patient or care giver. A Foley catheter, a pre- amendment device, was considered for a control treatment. However, although a Foley catheter is used to establish urinary drainage with close to 100% efficacy, it does not restore voiding function like the C3, and severely impairs activities of daily life.
The intrinsic design flaws of a Foley catheter traversing thru the urinary passage which violates the anatomical protective points which help to avoid bacterial contamination. The distal 1/3 portion of the urethra in females is commonly colonized with bacteria. Standard Catheter technique traverses from the outside into the entire length of the urethra to drain the bladder. The standard self catheter flow characteristics are impacted due to the placements of the "eyes" to the catheter lumen. The C3 lumen is open in line with the flow.
- Being tested
- C3 "UMBRELLA CATHETER"
- Medical subject headings
- Urinary Retention, Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C3 "UMBRELLA CATHETER"Device
The C3 is an alternative method to facilitate bladder drainage in the study population which are using either a foley catheter or Clean Intermittent Catheter technique to drain the bladder.
| Study group | Role | What they receive |
|---|---|---|
| C3 PATIENT PARTICIPANTS | Other | This single arm prospective study is designed to produce valid scientific evidence regarding safety and efficacy of the C3 in establishing urinary drainage and allowing the control of micturition when indwelling for up to 7 days in patients. The total study population will initially include 50 subjects with open enrollment of additional subjects. Receives: Device: C3 "UMBRELLA CATHETER" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheterization of the bladder from an antegrade direction with the C3 device.
The percentage for patients enrolled in the student with the C3 inserted who are able to engage the tubular portion of the device into the bladder neck and urethra from the default position in the bladder with resultant drainage of the bladdder.
Measured: Measurement of data points are collected sequentially every 7 days up to 28 days.
The retreat of the C3 back into the bladder from the engaged position
The percentage of enrolled patients who upon completion of bladder drainage with the engaged tubular portion of the C3 in bladder neck and urethral location retreats back into the default position in the bladder.
Measured: Measurement of data points are collected sequentially every 7 days up to 28 days.
Secondary outcomes (1)
Reduction in Catheter Acquired Urinary Tract Infection Rate
The reduction in Catheter Acquired Urinary Tract Infection (CAUTI) with the C3 "Umbrella Catheter" as compared to the expected incidence with either a Foley Catheter or Self Intermittent Catheter for bladder drainage.
Measured: Measurement of data points are collected sequentially every 7 days up to 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start31 Aug 2017
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Safety and efficacy of the Catheter Science C3 "Umbrella Catheter" in establishing urinary drainage and allowing the control of micturition when indwelling for up to 7 days. The reduction in Catheter Acquired Urinary Tract Infection (CAUTI) A single arm study design was chosen because there is no alternative treatment to serve as an appropriate control. The C3 catheterizes the bladder with engagement into the bladder neck under the control of the patient or care giver. A Foley catheter, a pre- amendment device, was considered for a control treatment. However, although a Foley catheter is used to establish urinary drainage with close to 100% efficacy, it does not restore voiding function like the C3, and severely impairs activities of daily life.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Gaines W. Hammond Jr. MD FACS
- Responsible party
- Sponsor-investigator, Dr. Gaines W. Hammond Jr. MD FACS, Hammond, Gaines W., Jr., M.D. FACS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353571
- Sponsor's protocol ID
- Study # 17/30/08
- Status last verified
- Nov 2017
- First submitted
- 24 Oct 2017
- Last updated
- 27 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: LISTED IN STUDY INFORMED CONSENT WITH NAME RECOGNITION WITHHELD
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of the Catheter Science C3 "Umbrella Catheter" for Patients With Urinary Retention Due to Bladder Dysfunction (C3 Catheter Study)
- ClinicalTrials.gov ID
- NCT03353571
- Acronym / sponsor ID
- Study # 17/30/08
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Dr. Gaines W. Hammond Jr. MD FACS
- Study start
- 31 Aug 2017 (actual)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 27 Nov 2017 (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 Catheter Science C3 "Umbrella Catheter" has been developed for management of urinary retention in patients who are either using a Foley or Self Intermittent Catheter. This device is inserted into the bladder in an extended state and once the stylet is removed the device folds into collapsed state. A thread is attached to the device and traverses thru the urethra and is attached to a bobber. With gentle traction on the thread the device engages the bladder neck and the central tube extends which allows for the flow of urine. Once voiding is complete, the thread is released and the device collapses back to the folded state into the bladder. Each voiding cycle is accomplished in a similar fashion. This is a novel technique in which the bladder is catheterized with the device from within the bladder into the bladder neck and urethra. The standard self catheter technique is for placement of a catheter from the outside into the urethra and into the bladder.
Detailed description
Interventional (clinical trial): Participants are assigned prospectively to an intervention or interventions according to a protocol to evaluate the effect of the intervention(s) on biomedical or other health related outcomes.
This single arm, prospective study is designed to produce valid scientific evidence regarding:
- Safety and efficacy of the Catheter Science C3 "Umbrella Catheter" in establishing urinary drainage and allowing the control of micturition when indwelling for up to 7 days.
- The reduction in Catheter Acquired Urinary Tract Infection (CAUTI)
A single arm study design was chosen because there is no alternative treatment to serve as an appropriate control. The C3 catheterizes the bladder with engagement into the bladder neck under the control of the patient or care giver. A Foley catheter, a pre- amendment device, was considered for a control treatment. However, although a Foley catheter is used to establish urinary drainage with close to 100% efficacy, it does not restore voiding function like the C3, and severely impairs activities of daily life.
The intrinsic design flaws of a Foley catheter traversing thru the urinary passage which violates the anatomical protective points which help to avoid bacterial contamination. The distal 1/3 portion of the urethra in females is commonly colonized with bacteria. Standard Catheter technique traverses from the outside into the entire length of the urethra to drain the bladder. The standard self catheter flow characteristics are impacted due to the placements of the "eyes" to the catheter lumen. The C3 lumen is open in line with the flow.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Safety and efficacy of the Catheter Science C3 "Umbrella Catheter" in establishing urinary drainage and allowing the control of micturition when indwelling for up to 7 days. The reduction in Catheter Acquired Urinary Tract Infection (CAUTI) A single arm study design was chosen because there is no alternative treatment to serve as an appropriate control. The C3 catheterizes the bladder with engagement into the bladder neck under the control of the patient or care giver. A Foley catheter, a pre- amendment device, was considered for a control treatment. However, although a Foley catheter is used to establish urinary drainage with close to 100% efficacy, it does not restore voiding function like the C3, and severely impairs activities of daily life.
| Arm | Type | Receives |
|---|---|---|
| C3 PATIENT PARTICIPANTS | Other | Device: C3 "UMBRELLA CATHETER"This single arm prospective study is designed to produce valid scientific evidence regarding safety and efficacy of the C3 in establishing urinary drainage and allowing the control of micturition when indwelling for up to 7 days in patients. The total study population will initially include 50 subjects with open enrollment of additional subjects. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with Bladder Dysfunction requiring mechanical drainage.
- Patients with actual urinary retention
Key exclusion criteria (2 listed)
- Inability to undergo bladder catheterization (e.g., urethral stricture or history of urethral stricture)
- Gross hematuria
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 |
|---|---|---|
| C3 "UMBRELLA CATHETER"The C3 is an alternative method to facilitate bladder drainage in the study population which are using either a foley catheter or Clean Intermittent Catheter technique to drain the bladder. | Device | C3 PATIENT PARTICIPANTS |
Primary outcome
Catheterization of the bladder from an antegrade direction with the C3 device.
Time frame: Measurement of data points are collected sequentially every 7 days up to 28 days.
The percentage for patients enrolled in the student with the C3 inserted who are able to engage the tubular portion of the device into the bladder neck and urethra from the default position in the bladder with resultant drainage of the bladdder.
The retreat of the C3 back into the bladder from the engaged position
Time frame: Measurement of data points are collected sequentially every 7 days up to 28 days.
The percentage of enrolled patients who upon completion of bladder drainage with the engaged tubular portion of the C3 in bladder neck and urethral location retreats back into the default position in the bladder.
1 secondary outcome
Reduction in Catheter Acquired Urinary Tract Infection Rate
Time frame: Measurement of data points are collected sequentially every 7 days up to 28 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2017.
- Individual participant dataSharing planned: Yes. LISTED IN STUDY INFORMED CONSENT WITH NAME RECOGNITION WITHHELD
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C3 "UMBRELLA CATHETER" in people with Urinary Retention and Urinary Bladder, Neurogenic, run by Dr. Gaines W. Hammond Jr. MD FACS at 1 site 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GAINES W HAMMOND, MD (863-680-7300, GHAMMOND@WATSONCLINIC.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Catheterization of the bladder from an antegrade direction with the C3 device. (time frame: Measurement of data points are collected sequentially every 7 days up to 28 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 27 Nov 2017.