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:
Information provided by (Responsible Party):
ThermaRx, Inc.
ClinicalTrials.gov Identifier:
NCT00700505
First received: June 11, 2008
Last updated: August 13, 2012
Last verified: August 2012
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   25 Years to 80 Years
Genders 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
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 ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

Responsible Party: ThermaRx, Inc.
ClinicalTrials.gov Identifier: NCT00700505     History of Changes
Other Study ID Numbers: TR-DM-001
Study First Received: June 11, 2008
Last Updated: August 13, 2012
Health Authority: United States: Institutional Review Board

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:
Prostatic Hyperplasia
Hyperplasia
Urinary Retention
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Urination Disorders
Urologic Diseases

ClinicalTrials.gov processed this record on July 20, 2014