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

August 13, 2012 updated by: ThermaRx, Inc.
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77024
        • Mobley Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Post-void residual urinary volume (PVR)
Time Frame: Both Study Day 1 & 2 before/after oral fluid load
Both Study Day 1 & 2 before/after oral fluid load

Secondary Outcome Measures

Outcome Measure
Time Frame
Voided volume percentage (%) based on pre-void and post-void ultrasound volumes
Time Frame: Both Study Day 1 & 2 before/after oral fluid load
Both Study Day 1 & 2 before/after oral fluid load

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ThermaRx, Inc.

Investigators

  • Principal Investigator: David Mobley, M.D., Mobley Clinical Research Center
  • Study Director: John T La, Mobley Clinical Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

June 11, 2008

First Submitted That Met QC Criteria

June 13, 2008

First Posted (Estimate)

June 18, 2008

Study Record Updates

Last Update Posted (Estimate)

August 14, 2012

Last Update Submitted That Met QC Criteria

August 13, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TR-DM-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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