A Study to Determine the Safety and Efficacy of a New Non-invasive Heating Garment to Reduce Urinary Hesitancy
NCT00700505 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2012-08-14
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).
Conditions
- Benign Prostatic Hyperplasia (BPH)
- Urinary Retention
- Urinary Hesitancy Intermittent
Interventions
- DEVICE
-
FlowPants(R) Garment
The garment is shaped like a pair of boxer briefs. Garment heating is battery-powered. The garment is activated and begins to heat up 5-15 minutes prior to voiding.
Sponsors & Collaborators
-
ThermaRx, Inc.
lead INDUSTRY
Principal Investigators
-
David Mobley, M.D. · Mobley Clinical Research Center
-
John T La · Mobley Clinical Research Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 25 Years
- Max Age
- 80 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-04-30
- Primary Completion
- 2009-10-31
- Completion
- 2009-12-31
Countries
- United States
Study Locations
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