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

Completed · Not applicable

Conditions studied: Benign Prostatic Hyperplasia (BPH), Urinary Retention, Urinary Hesitancy Intermittent

In brief

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).

Key facts

Study ID

NCT00700505

Run by

ThermaRx, Inc.

People needed

20

Starts

2008-04-01

Expected to finish

2009-12-01

Last updated by the study team

2012-08-14

Who can join

Age: 25 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• History of prostate cancer or prostate surgery
• Currently (or within the past 30 days) on active treatment for prostate problems

Where it is running

• Mobley Clinical Research Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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