Status:
COMPLETED
A Study to Determine the Safety and Efficacy of a New Non-invasive Heating Garment to Reduce Urinary Hesitancy
Lead Sponsor:
ThermaRx, Inc.
Conditions:
Benign Prostatic Hyperplasia (BPH)
Urinary Retention
Eligibility:
MALE
25-80 years
Phase:
NA
Brief Summary
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).
Detailed Description
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 sugge...
Eligibility Criteria
Inclusion
- 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
- History of prostate cancer or prostate surgery
- Currently (or within the past 30 days) on active treatment for prostate problems
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00700505
Start Date
April 1 2008
End Date
December 1 2009
Last Update
August 14 2012
Active Locations (1)
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1
Mobley Clinical Research Center
Houston, Texas, United States, 77024