Urologic InjuriesNCT03108079
Bladder Morphology Using 2 Different Catheter Designs
A study testing Cystosure Urinary Access System and Foley Catheter in people with Urologic Injuries and Urologic Diseases, run by The Pelvic Floor Institute at 1 site in United States.
Trial summary
Demonstrate and compare the 3D morphology of the bladder wall in full and drained states with 2 different kinds of bladder catheters in place. (Foley Catheter vs. Cystosure Catheter) Read more about this study
- Who is it for?
- Ages 21 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urologic Injuries, Urologic Diseases, Bladder Infection
- What is being tested?
- Cystosure Urinary Access System and Foley Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2017to Jun 2017
- 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 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pelvic Floor Institute patients aged between 21 and 70 years of age, who are able to speak and understand English, who are not currently pregnant, or had a pregnancy in the previous 6 months.
Who cannot join
- Women with claustrophobia or any contraindication to undergoing an MRI scan will be excluded. Similarly, women with hip, knee, or shoulder replacements will be excluded because of the need for urethral catheterization. Women with significant mitral valve prolapse will also be excluded for the same reason. Women with history of 3 or more culture-documented UTIs over the last 12 months will be excluded. Women who are unable or unwilling to give informed consent will also be excluded. Women who are unable to tolerate 300 cc of fluid in the bladder will be excluded. Women with a nitrite-positive urinalysis at the time of study enrollment will be excluded until they can demonstrate a negative urine culture.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The Pelvic Floor Institute
Tampa, Florida, 33609
Lennox Hoyte, MD, MSEECS, 813-551-3540, lhoyte@mypfi.org
Jerry B Owens, 877-876-2972, innovativeresearchinc@gmail.com
About this study
Official title: Bladder Morphology Using 2 Different Catheter Designs Foley Catheter vs. Cystosure Urinary Access System
Demonstrate and compare the 3D morphology of the bladder wall in full and drained states with 2 different kinds of bladder catheters in place. (Foley Catheter vs. Cystosure Catheter)
Read the detailed description
The Foley catheter has been the mainstay of bladder drainage for many decades. There has been little design change despite risks associated with Foley catheter use including cather associated Urinary Tract Infections(UTIs). However, recent incentives and penalties related to iatrogenic bladder infections have encouraged healthcare providers to search for ways to decrease catheter-associated infections. Data suggests that the design of the traditional Foley catheter may be responsible for bladder mucosal injury due to contact with the drainage tip, which in turn contribute to bladder infections associated with long term indwelling Foley catheter usage. The Cystosure catheter is an FDA approved bladder drainage device, with a shortened drainage port, designed to avoid contact with the bladder mucosa. It is postulated that the lack of contact with the mucosa would decrease mucosal injury, possibly leading to decreased incidence of catheter related bladder infections. Early sheep bladder microscopy studies have suggested that the Cystosure catheter produces significantly less mucosal injury compared to the Foley catheter following a short period of indwelling bladder catheterization. The present study is designed to compare bladder wall geometry around the drainage balloon in the Foley versus the Cystosure drainage catheters in living women. It is hypothesized that the "tip-less" cystosure catheter will have a smoother, more continuous bladder contour around the drainage port, compared to the traditional Foley catheter tip.
- Conditions
- Urologic Injuries, Urologic Diseases, Bladder Infection, Urinary Tract Infections, Mucosal Inflammation, Mucosal Infection
- Being tested
- Cystosure Urinary Access System, Foley Catheter
- Keywords
- Urologic Injuries, Urologic Diseases, Bladder Infection, Urinary Tract Infections, Mucosal Inflammation, Mucosal Infection, Bladder Injury, Catheter Related Infections, Catheter Complications, Catheter Infection, Indwelling Catheter, Pelvic Floor Disorders, Urinary Incontinence
- Medical subject headings
- Urologic Diseases, Cystitis, Urinary Tract Infections, Mucositis, Catheter-Related Infections, Infections, Pelvic Floor Disorders, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cystosure Urinary Access SystemDevice
Also called Emmy Medical Cystosure Urinary Access System 10-200
- Demonstrate the 3D bladder wall anatomy with 300 cc of fluid infused with each of the following bladder drainage mechanisms
- The traditional Foley catheter (Catheter A)
- The novel FDA approved Cystosure catheter (Catheter B)
- Compare the fluid flow pattern during bladder drainage for
- The traditional Foley catheter (Catheter A)
- The novel FDA approved Cystosure catheter (Catheter B)
- Compare the 3D bladder wall anatomy after emptying the bladder with
- The traditional Foley catheter (Catheter A)
- The novel FDA approved Cystosure catheter (Catheter B)
Foley CatheterDevice
Also called BARD Medical Foley Catheter
- Demonstrate the 3D bladder wall anatomy with 300 cc of fluid infused with each of the following bladder drainage mechanisms
- The traditional Foley catheter (Catheter A)
- The novel FDA approved Cystosure catheter (Catheter B)
- Compare the fluid flow pattern during bladder drainage for
- The traditional Foley catheter (Catheter A)
- The novel FDA approved Cystosure catheter (Catheter B)
- Compare the 3D bladder wall anatomy after emptying the bladder with
- The traditional Foley catheter (Catheter A)
- The novel FDA approved Cystosure catheter (Catheter B)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Women who agree to participate will undergo a standard high resolution, thin slice pelvic floor static/dynamic MRI study, first with a full bladder, and after the bladder is emptied. Bladder filling and drainage will be performed sequentially, using each of the 2 catheter types (Cystosure Urinary Access Catheter and Foley Catheter). During bladder emptying, a cine video scan will be taken at the midsagittal plane to show the dynamics of the bladder fluid and walls during emptying. Each subject will serve as their own control.
Interventions are listed in the "Interventions" Section. Receives: Device: Cystosure Urinary Access System; Device: Foley Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder shape after emptying
Bladder shape after emptying using both catheters will be assessed. The 3D reconstructed images will be compared to determine if there are any differences in bladder shape in full and empty states between the 2 catheter types.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study startApr 2017 (estimated)
- Primary completionMay 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic InjuriesStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Female patients seen at the Pelvic Floor Institute will be offered participation in the study. The study will consist of a pelvic floor MRI at no cost to them or their payors. Women who agree to participate will undergo a standard high resolution, thin slice pelvic floor static/dynamic MRI study, first with a full bladder, and after the bladder is emptied. Bladder filling and drainage will be performed sequentially, using each of the 2 catheter types (A and B above) in sequence. During bladder emptying, a cine video scan will be taken at the midsagittal plane to show the dynamics of the bladder fluid and walls during emptying. Each subject will serve as their own control.
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Pelvic Floor Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Cystosure, Innovative Research Inc.
- Responsible party
- Principal investigator, Lennox Hoyte, MD, The Pelvic Floor Institute
- Investigators
- Lennox Hoyte, MD, MSEECS, Principal investigator, The Pelvic Floor Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108079
- Sponsor's protocol ID
- 03082017
- Status last verified
- Apr 2017
- First submitted
- 30 Mar 2017
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bladder Morphology Using 2 Different Catheter Designs Foley Catheter vs. Cystosure Urinary Access System
- ClinicalTrials.gov ID
- NCT03108079
- Acronym / sponsor ID
- 03082017
- Conditions
- Urologic Injuries, Urologic Diseases, Bladder Infection, Urinary Tract Infections, Mucosal Inflammation, Mucosal Infection
- Keywords
- Urologic Injuries, Urologic Diseases, Bladder Infection, Urinary Tract Infections, Mucosal Inflammation, Mucosal Infection, Bladder Injury, Catheter Related Infections
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- The Pelvic Floor InstituteUniversity, hospital or other
- Collaborators
- Cystosure, Innovative Research Inc.
- Study start
- Apr 2017 (estimated)
- Primary completion
- May 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 11 Apr 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.
Demonstrate and compare the 3D morphology of the bladder wall in full and drained states with 2 different kinds of bladder catheters in place. (Foley Catheter vs. Cystosure Catheter)
Detailed description
The Foley catheter has been the mainstay of bladder drainage for many decades. There has been little design change despite risks associated with Foley catheter use including cather associated Urinary Tract Infections(UTIs). However, recent incentives and penalties related to iatrogenic bladder infections have encouraged healthcare providers to search for ways to decrease catheter-associated infections. Data suggests that the design of the traditional Foley catheter may be responsible for bladder mucosal injury due to contact with the drainage tip, which in turn contribute to bladder infections associated with long term indwelling Foley catheter usage. The Cystosure catheter is an FDA approved bladder drainage device, with a shortened drainage port, designed to avoid contact with the bladder mucosa. It is postulated that the lack of contact with the mucosa would decrease mucosal injury, possibly leading to decreased incidence of catheter related bladder infections. Early sheep bladder microscopy studies have suggested that the Cystosure catheter produces significantly less mucosal injury compared to the Foley catheter following a short period of indwelling bladder catheterization. The present study is designed to compare bladder wall geometry around the drainage balloon in the Foley versus the Cystosure drainage catheters in living women. It is hypothesized that the "tip-less" cystosure catheter will have a smoother, more continuous bladder contour around the drainage port, compared to the traditional Foley catheter tip.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Female patients seen at the Pelvic Floor Institute will be offered participation in the study. The study will consist of a pelvic floor MRI at no cost to them or their payors. Women who agree to participate will undergo a standard high resolution, thin slice pelvic floor static/dynamic MRI study, first with a full bladder, and after the bladder is emptied. Bladder filling and drainage will be performed sequentially, using each of the 2 catheter types (A and B above) in sequence. During bladder emptying, a cine video scan will be taken at the midsagittal plane to show the dynamics of the bladder fluid and walls during emptying. Each subject will serve as their own control.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Device: Cystosure Urinary Access System, Device: Foley CatheterWomen who agree to participate will undergo a standard high resolution, thin slice pelvic floor static/dynamic MRI study, first with a full bladder, and after the bladder is emptied. Bladder filling and drainage will be performed sequentially, using each of the 2 catheter types (Cystosure Urinary Access Catheter and Foley Catheter). During bladder emptying, a cine video scan will be taken at the midsagittal plane to show the dynamics of the bladder fluid and walls during emptying. Each subject will serve as their own control. Interventions are listed in the "Interventions" Section. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pelvic Floor Institute patients aged between 21 and 70 years of age, who are able to speak and understand English, who are not currently pregnant, or had a pregnancy in the previous 6 months.
Key exclusion criteria (1 listed)
- Women with claustrophobia or any contraindication to undergoing an MRI scan will be excluded. Similarly, women with hip, knee, or shoulder replacements will be excluded because of the need for urethral catheterization. Women with significant mitral valve prolapse will also be excluded for the same reason. Women with history of 3 or more culture-documented UTIs over the last 12 months will be excluded. Women who are unable or unwilling to give informed consent will also be excluded. Women who are unable to tolerate 300 cc of fluid in the bladder will be excluded. Women with a nitrite-positive urinalysis at the time of study enrollment will be excluded until they can demonstrate a negative urine culture.
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 |
|---|---|---|
| Cystosure Urinary Access SystemAlso: Emmy Medical Cystosure Urinary Access System 10-2001. Demonstrate the 3D bladder wall anatomy with 300 cc of fluid infused with each of the following bladder drainage mechanisms 1. The traditional Foley catheter (Catheter A) 2. The novel FDA approved Cystosure catheter (Catheter B) 2. Compare the fluid flow pattern during bladder drainage for 1. The traditional Foley catheter (Catheter A) 2. The novel FDA approved Cystosure catheter (Catheter B) 3. Compare the 3D bladder wall anatomy after emptying the bladder with 1. The traditional Foley catheter (Catheter A) 2. The novel FDA approved Cystosure catheter (Catheter B) | Device | Arm 1 |
| Foley CatheterAlso: BARD Medical Foley Catheter1. Demonstrate the 3D bladder wall anatomy with 300 cc of fluid infused with each of the following bladder drainage mechanisms 1. The traditional Foley catheter (Catheter A) 2. The novel FDA approved Cystosure catheter (Catheter B) 2. Compare the fluid flow pattern during bladder drainage for 1. The traditional Foley catheter (Catheter A) 2. The novel FDA approved Cystosure catheter (Catheter B) 3. Compare the 3D bladder wall anatomy after emptying the bladder with 1. The traditional Foley catheter (Catheter A) 2. The novel FDA approved Cystosure catheter (Catheter B) | Device | Arm 1 |
Primary outcome
Bladder shape after emptying
Time frame: 1 month
Bladder shape after emptying using both catheters will be assessed. The 3D reconstructed images will be compared to determine if there are any differences in bladder shape in full and empty states between the 2 catheter types.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Lennox Hoyte, MD, MSEECS principal investigator
The Pelvic Floor Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cystosure Urinary Access System and Foley Catheter in people with Urologic Injuries and Urologic Diseases, run by The Pelvic Floor Institute 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 1 inclusion and 1 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 12 Apr 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 Lennox Hoyte, MD, MSEECS (813-551-3540, lhoyte@mypfi.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder shape after emptying (time frame: 1 month). 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 12 Apr 2017.