Bladder Morphology Using 2 Different Catheter Designs
Status unconfirmed · Not applicable
Conditions studied: 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
In brief
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)
Key facts
- Study ID
- NCT03108079
- Run by
- The Pelvic Floor Institute
- People needed
- 3
- Starts
- 2017-04-01
- Expected to finish
- 2017-06-01
- Last updated by the study team
- 2017-04-12
Who can join
Age: 21 and older, up to 70. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- The Pelvic Floor Institute — Tampa, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
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