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

This study has been completed.
Information provided by (Responsible Party):
ThermaRx, Inc. Identifier:
First received: June 11, 2008
Last updated: August 13, 2012
Last verified: August 2012
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).

Condition Intervention
Benign Prostatic Hyperplasia (BPH) Urinary Retention Urinary Hesitancy Intermittent Device: FlowPants(R) Garment

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Determine the Safety and Efficacy of a New Non-invasive Heating Garment to Reduce Urinary Hesitancy

Further study details as provided by ThermaRx, Inc.:

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

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

Enrollment: 20
Study Start Date: April 2008
Study Completion Date: December 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.


Ages Eligible for Study:   25 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00700505

United States, Texas
Mobley Clinical Research Center
Houston, Texas, United States, 77024
Sponsors and Collaborators
ThermaRx, Inc.
Principal Investigator: David Mobley, M.D. Mobley Clinical Research Center
Study Director: John T La Mobley Clinical Research Center
  More Information

Responsible Party: ThermaRx, Inc. Identifier: NCT00700505     History of Changes
Other Study ID Numbers: TR-DM-001
Study First Received: June 11, 2008
Last Updated: August 13, 2012

Keywords provided by ThermaRx, Inc.:
Benign Prostatic Hyperplasia
Benign Prostatic Hypertrophy
Urinary Retention
Shy Bladder
Urinary Hesitancy
Bashful Bladder

Additional relevant MeSH terms:
Prostatic Hyperplasia
Urinary Retention
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Urination Disorders
Urologic Diseases processed this record on August 18, 2017