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| Name | Class |
|---|---|
| Cystosure | UNKNOWN |
| Innovative Research Inc. | UNKNOWN |
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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cystosure Urinary Access System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
Patients in the trial must be female.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lennox Hoyte, MD, MSEECS | Contact | 813-551-3540 | lhoyte@mypfi.org | |
| Jerry B Owens | Contact | 877-876-2972 | innovativeresearchinc@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Lennox Hoyte, MD, MSEECS | The Pelvic Floor Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Pelvic Floor Institute | Recruiting | Tampa | Florida | 33609 | United States |
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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.
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|
| Foley Catheter | Device |
|
|
|
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D003556 | Cystitis |
| D014552 | Urinary Tract Infections |
| D052016 | Mucositis |
| D055499 | Catheter-Related Infections |
| D007239 | Infections |
| D059952 | Pelvic Floor Disorders |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D011248 | Pregnancy Complications |
| D014555 | Urination Disorders |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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