Expired Study
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Houston, Texas 77024


Purpose:

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).


Study summary:

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.


Criteria:

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


NCT ID:

NCT00700505


Primary Contact:

Principal Investigator
David Mobley, M.D.
Mobley Clinical Research Center


Backup Contact:

N/A


Location Contact:

Houston, Texas 77024
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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