Back to resultsA Study to Determine the Safety and Efficacy of a New Non-invasive Heating Garment to Reduce Urinary Hesitancy
Primary Purpose
Benign Prostatic Hyperplasia (BPH), Urinary Retention, Urinary Hesitancy Intermittent
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FlowPants(R) Garment
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia (BPH) focused on measuring Benign Prostatic Hyperplasia, BPH, Benign Prostatic Hypertrophy, Urinary Retention, Shy Bladder, Urinary Hesitancy, Bashful Bladder, Paruresis
Eligibility 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
Sites / Locations
- Mobley Clinical Research Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Heating Garment
Arm Description
FlowPants(R) Garment with Heating
Outcomes
Primary Outcome Measures
Post-void residual urinary volume (PVR)
Secondary Outcome Measures
Voided volume percentage (%) based on pre-void and post-void ultrasound volumes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00700505
Brief Title
A Study to Determine the Safety and Efficacy of a New Non-invasive Heating Garment to Reduce Urinary Hesitancy
Official Title
A Study to Determine the Safety and Efficacy of a New Non-invasive Heating Garment to Reduce Urinary Hesitancy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ThermaRx, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia (BPH), Urinary Retention, Urinary Hesitancy Intermittent
Keywords
Benign Prostatic Hyperplasia, BPH, Benign Prostatic Hypertrophy, Urinary Retention, Shy Bladder, Urinary Hesitancy, Bashful Bladder, Paruresis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Heating Garment
Arm Type
Experimental
Arm Description
FlowPants(R) Garment with Heating
Intervention Type
Device
Intervention Name(s)
FlowPants(R) Garment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post-void residual urinary volume (PVR)
Time Frame
Both Study Day 1 & 2 before/after oral fluid load
Secondary Outcome Measure Information:
Title
Voided volume percentage (%) based on pre-void and post-void ultrasound volumes
Time Frame
Both Study Day 1 & 2 before/after oral fluid load
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Mobley, M.D.
Organizational Affiliation
Mobley Clinical Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John T La
Organizational Affiliation
Mobley Clinical Research Center
Official's Role
Study Director
Facility Information:
Facility Name
Mobley Clinical Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.thermarx.com
Description
Heat Therapy
Learn more about this trial
A Study to Determine the Safety and Efficacy of a New Non-invasive Heating Garment to Reduce Urinary Hesitancy
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