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This is an observational, exploratory study designed to collect (record) and analyze normal and abnormal sound data from the human bladder during surgery using a novel sensor-based catheter system (Electronic Catheter Stethoscope) and to develop algorithms to detect changes of baseline bladder and ureteral function. The Electronic Catheter Stethoscope device will measure acoustic and pressure data within the bladder. The measurements will be used to detect any leakage from the bladder and/or changes in baseline ureteral flow by correlation of sound data with surgical data reported by the surgeon. These data will be used to develop algorithms to detect changes of baseline bladder and ureteral function. The algorithms will be tested in future clinical trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electronic Catheter Stethoscope |
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| Measure | Description | Time Frame |
|---|---|---|
| bladder and ureter sounds during pelvic surgery. | from time of bladder catheter placement and initiation of recording during surgery to completion of pelvic surgery (within 8 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| changes from baseline bladder and ureteral function sounds | from time of bladder catheter placement and initiation of recording during surgery to completion of pelvic surgery (within 8 hours) |
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Inclusion Criteria
age 18 or older
plan to have one of the following types of surgery:
able to provide written informed consent
Exclusion Criteria
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Current patients having gynecological surgery
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Hart, MD | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Center Operating Rooms at the Tampa General Hospital | Tampa | Florida | 33606 | United States |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D047708 | Myofibroma |
| D062788 | Adenomyosis |
| D004714 | Endometrial Hyperplasia |
| D014592 | Uterine Hemorrhage |
| D017699 | Pelvic Pain |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009372 | Neoplasms, Connective Tissue |
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| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |