Urinary Retention Clinical Trial
Official title:
A Study to Determine the Safety and Efficacy of a New Non-invasive Heating Garment to Reduce Urinary Hesitancy
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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