Benign Prostatic Hyperplasia (BPH), Urinary Hesitancy Intermittent, Urinary Retention
Conditions
Keywords
Benign Prostatic Hyperplasia, BPH, Benign Prostatic Hypertrophy, Urinary Retention, Shy Bladder, Urinary Hesitancy, Bashful Bladder, Paruresis
Brief summary
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
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.
Interventions
DEVICEFlowPants(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.
Sponsors
ThermaRx, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
25 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-void residual urinary volume (PVR) | Both Study Day 1 & 2 before/after oral fluid load |
Secondary
| Measure | Time frame |
|---|---|
| Voided volume percentage (%) based on pre-void and post-void ultrasound volumes | Both Study Day 1 & 2 before/after oral fluid load |
Countries
United States
Outcome results
None listed