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

ThermaRx, Inc.20 enrolled

Overview

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).

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Benign Prostatic Hyperplasia (BPH)Urinary Retention Urinary Hesitancy Intermittent

Interventions

FlowPants(R) GarmentDEVICE

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.

Eligibility

Sex: MALEMin age: 25 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Mobley Clinical Research Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Post-void residual urinary volume (PVR)

Time frame: Both Study Day 1 & 2 before/after oral fluid load

Secondary Outcomes

Voided volume percentage (%) based on pre-void and post-void ultrasound volumes

Time frame: Both Study Day 1 & 2 before/after oral fluid load

Data from ClinicalTrials.gov

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