- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03108079
Bladder Morphology Using 2 Different Catheter Designs
Bladder Morphology Using 2 Different Catheter Designs Foley Catheter vs. Cystosure Urinary Access System
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lennox Hoyte, MD, MSEECS
- Phone Number: 813-551-3540
- Email: lhoyte@mypfi.org
Study Contact Backup
- Name: Jerry B Owens
- Phone Number: 877-876-2972
- Email: innovativeresearchinc@gmail.com
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33609
- Recruiting
- The Pelvic Floor Institute
-
Contact:
- Lennox Hoyte, MD, MSEECS
- Phone Number: 813-551-3540
- Email: lhoyte@mypfi.org
-
Contact:
- Jerry B Owens
- Phone Number: 877-876-2972
- Email: innovativeresearchinc@gmail.com
-
Principal Investigator:
- Lennox Hoyte, MD, MSEECS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Arm 1
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. |
Other Names:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lennox Hoyte, MD, MSEECS, The Pelvic Floor Institute
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Digestive System Diseases
- Pathologic Processes
- Urinary Bladder Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Disease Attributes
- Gastrointestinal Diseases
- Gastroenteritis
- Stomatognathic Diseases
- Urination Disorders
- Mouth Diseases
- Pregnancy Complications
- Elimination Disorders
- Cystitis
- Urinary Incontinence
- Inflammation
- Infections
- Communicable Diseases
- Wounds and Injuries
- Urinary Tract Infections
- Mucositis
- Enuresis
- Pelvic Floor Disorders
- Catheter-Related Infections
- Urologic Diseases
Other Study ID Numbers
- 03082017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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