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| ID | Type | Description | Link |
|---|---|---|---|
| 1R44DK131700 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The goal of this prospective trial is to assess the safety and reliability of the Glean Urodynamics System (GUS) in adult females with lower urinary tract symptoms. The main question[s] it aims to answer are:
• What is GUS's ability to safely and reliably conduct wireless, catheter-free monitoring of vesical pressure compared to the vesical pressures collected with conventional urodynamics?
Participants will undergo a conventional urodynamics exam, a simultaneous urodynamics exam with GUS, ambulatory urodynamics with GUS, and extended home monitoring with GUS.
Researchers will compare GUS data with that from a conventional urodynamics exam.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glean Urodynamics System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glean Urodynamics System | Device | Wireless, catheter-free urodynamics system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Proportion of participants experiencing a qualifying adverse event attributable to the investigational device | From date of enrollment to study exit (up to 43 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Vesical pressure | Vesical pressure | during the procedure/surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tri Valley Urology Medical Group | Murrieta | California | 92562 | United States | ||
| University of California San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37293725 | Background | Frainey BT, Majerus SJA, Derisavifard S, Lewis KC, Williams AR, Balog BM, Butler RS, Goldman HB, Damaser MS. First in Human Subjects Testing of the UroMonitor: A Catheter-free Wireless Ambulatory Bladder Pressure Monitor. J Urol. 2023 Jul;210(1):186-195. doi: 10.1097/JU.0000000000003451. Epub 2023 Jun 9. |
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| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D014549 | Urinary Incontinence |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| Glean Urodynamics System | Device | Wireless and catheter free urodynamics system |
|
| San Diego |
| California |
| 92121 |
| United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| D014555 | Urination Disorders |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001745 | Urinary Bladder Diseases |