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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00700505
First Posted: June 18, 2008
Last Update Posted: August 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ThermaRx, Inc.
  Purpose
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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00700505


Locations
United States, Texas
Mobley Clinical Research Center
Houston, Texas, United States, 77024
Sponsors and Collaborators
ThermaRx, Inc.
Investigators
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.
ClinicalTrials.gov Identifier: NCT00700505     History of Changes
Other Study ID Numbers: TR-DM-001
First Submitted: June 11, 2008
First Posted: June 18, 2008
Last Update Posted: August 14, 2012
Last Verified: August 2012

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

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Urinary Retention
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Urination Disorders
Urologic Diseases