A Study to Determine the Safety and Efficacy of a New Non-invasive Heating Garment to Reduce Urinary Hesitancy
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.
Inclusion Criteria:

 -  Male subjects 25-80 years of age at the screening visit.

 -  Subject must have mild-to-moderate urinary hesitancy symptoms (shown as an American
 Urological Association Symptom Index (AUA-SI) score of 7-19).

 -  Symptoms include (not limited to):

 -  Leaking or dribbling of urine

 -  More frequent urination, especially at night

 -  Urgency to urinate

 -  Urine retention (inability to urinate)

 -  Hesitant, interrupter or weak stream of urine

 -  Inability or difficulty to urinate in public

 Exclusion Criteria:

 -  History of prostate cancer or prostate surgery

 -  Currently (or within the past 30 days) on active treatment for prostate problems