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

Not Applicable

Completed

• Conditions: Benign Prostatic Hyperplasia (BPH); Urinary Retention; Urinary Hesitancy Intermittent
• Interventions: Device: FlowPants(R) Garment

• Registration Number: NCT00700505
• Lead Sponsor: ThermaRx, Inc.

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.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-06-11
• Study First Submitted QC: 2008-06-13
• Study First Posted: 2008-06-18
• Primary Completion: 2009-10
• Study Completion: 2009-12
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-13
• Last Update Posted: 2012-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Heating Garment	FlowPants(R) Garment	FlowPants(R) Garment with Heating

Primary Outcome Measures

Name	Time	Method
Post-void residual urinary volume (PVR)	Both Study Day 1 & 2 before/after oral fluid load

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mobley Clinical Research Center; 🇺🇸 Houston, Texas, United States