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

ThermaRx

Status

Completed

Conditions

Urinary Retention

Benign Prostatic Hyperplasia (BPH)

Urinary Hesitancy Intermittent

Treatments

Device: FlowPants(R) Garment

Study type

Interventional

Funder types

Industry

Identifiers

NCT00700505

TR-DM-001

Details and patient eligibility

About

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).

Full 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.

Enrollment

20 patients

Sex

Male

Ages

25 to 80 years old

Volunteers

No Healthy Volunteers

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