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To determine the safety and efficacy of the ThermaRx heating device for the application of controlled low level heat to improve symptoms of LUT dysfunction (hesitancy, urgency).
This study will assess the safety and efficacy of ThermaRx heat treatment in subjects who have urinary hesitancy.
The rationale for this approach is based on anecdotal evidence and case reports suggesting that urinary hesitancy can be effectively reduced by external skin heating (hot tub "Jacuzzi" effect, perineal hot water spray). However, to date, there have been no formal studies of this non-invasive form of treatment, and the mechanism of action is still unclear.
This is a two-day study in which each subject will receive an oral fluid load and then one (1) heating treatment with the device. Ultrasound-based measurements of bladder volume will be performed both before and after voiding. On Day 1, voiding will be performed in a standing position; on Day 2, voiding will be done in a sitting position.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heating Garment | Experimental | FlowPants(R) Garment with Heating |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FlowPants(R) Garment | Device | The garment is shaped like a pair of boxer briefs. Garment heating is battery-powered. The garment is activated and begins to heat up 5-15 minutes prior to voiding. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-void residual urinary volume (PVR) | Both Study Day 1 & 2 before/after oral fluid load |
| Measure | Description | Time Frame |
|---|---|---|
| Voided volume percentage (%) based on pre-void and post-void ultrasound volumes | Both Study Day 1 & 2 before/after oral fluid load |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Mobley, M.D. | Mobley Clinical Research Center | Principal Investigator |
| John T La | Mobley Clinical Research Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobley Clinical Research Center | Houston | Texas | 77024 | United States |
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| Label | URL |
|---|---|
| Heat Therapy | View source |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| D016055 | Urinary Retention |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| D052801 |
| Male Urogenital Diseases |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |