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

NCT ID: NCT00700505

Last Updated: 2012-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Benign Prostatic Hyperplasia (BPH) Urinary Retention Urinary Hesitancy Intermittent

Keywords

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Benign Prostatic Hyperplasia BPH Benign Prostatic Hypertrophy Urinary Retention Shy Bladder Urinary Hesitancy Bashful Bladder Paruresis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Heating Garment

FlowPants(R) Garment with Heating

Group Type EXPERIMENTAL

FlowPants(R) Garment

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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ThermaRx, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Mobley, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mobley Clinical Research Center

John T La

Role: STUDY_DIRECTOR

Mobley Clinical Research Center

Locations

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Mobley Clinical Research Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.thermarx.com

Heat Therapy

Other Identifiers

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TR-DM-001

Identifier Type: -

Identifier Source: org_study_id