A Study to Determine the Safety and Efficacy of a New Non-invasive Heating Garment to Reduce Urinary Hesitancy
|ClinicalTrials.gov Identifier: NCT00700505|
Recruitment Status : Completed
First Posted : June 18, 2008
Last Update Posted : August 14, 2012
|Condition or disease||Intervention/treatment||Phase|
|Benign Prostatic Hyperplasia (BPH) Urinary Retention Urinary Hesitancy Intermittent||Device: FlowPants(R) Garment||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study to Determine the Safety and Efficacy of a New Non-invasive Heating Garment to Reduce Urinary Hesitancy|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||December 2009|
Experimental: Heating Garment
FlowPants(R) Garment with Heating
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.
- Post-void residual urinary volume (PVR) [ Time Frame: Both Study Day 1 & 2 before/after oral fluid load ]
- Voided volume percentage (%) based on pre-void and post-void ultrasound volumes [ Time Frame: Both Study Day 1 & 2 before/after oral fluid load ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00700505
|United States, Texas|
|Mobley Clinical Research Center|
|Houston, Texas, United States, 77024|
|Principal Investigator:||David Mobley, M.D.||Mobley Clinical Research Center|
|Study Director:||John T La||Mobley Clinical Research Center|