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

Study Overview
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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.

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

Conditions
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Benign Prostatic Hyperplasia (BPH), Urinary Retention, Urinary Hesitancy Intermittent

Intervention / Treatment
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* Device: FlowPants(R) Garment


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heating Garment<br>FlowPants(R) Garment with Heating | Device: FlowPants(R) Garment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-void residual urinary volume (PVR) |  | Both Study Day 1 & 2 before/after oral fluid load | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Voided volume percentage (%) based on pre-void and post-void ultrasound volumes |  | Both Study Day 1 & 2 before/after oral fluid load | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benign Prostatic Hyperplasia, BPH, Benign Prostatic Hypertrophy, Urinary Retention, Shy Bladder, Urinary Hesitancy, Bashful Bladder, Paruresis