NCT00700505

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: ThermaRx, Inc. · Industry
• Sex: Male
• Age: 25 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Benign Prostatic Hyperplasia (BPH)
• Urinary Retention
• Urinary Hesitancy Intermittent

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-10-01
• Completion: 2009-12-01
• First posted: 2008-06-18
• Last updated: 2012-08-14

Locations

1 site across 1 country: United States