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

Urinary Retention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00700505
• Other study ID #: TR-DM-001
• Status: Completed
• Phase: N/A
• First received: June 11, 2008
• Last updated: August 13, 2012
• Start date: April 2008
• Est. completion date: December 2009

Study information

• Verified date: August 2012
• Source: ThermaRx, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Mobley Clinical Research Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
ThermaRx, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-void residual urinary volume (PVR)		Both Study Day 1 & 2 before/after oral fluid load	No
Secondary	Voided volume percentage (%) based on pre-void and post-void ultrasound volumes		Both Study Day 1 & 2 before/after oral fluid load	No

External Links

•   Heat Therapy