Trials Sponsors Conditions Drugs Pricing

Conditions

Benign Prostatic Hyperplasia (BPH)Urinary Hesitancy Intermittent Urinary Retention

Keywords

Benign Prostatic HyperplasiaBPHBenign Prostatic HypertrophyUrinary RetentionShy BladderUrinary HesitancyBashful BladderParuresis

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Study Arms (1)

Heating Garment

EXPERIMENTAL

FlowPants(R) Garment with Heating

Device: FlowPants(R) Garment

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.

Heating Garment

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age25 Years - 80 Years

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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).

Sponsors & Collaborators

ThermaRx, Inc.
Industrylead

Study Sites (1)

Mobley Clinical Research Center

Houston, Texas, 77024, United States

MeSH Terms

Conditions

Prostatic HyperplasiaUrinary Retention

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Study Officials

David Mobley, M.D.
Mobley Clinical Research Center
PRINCIPAL INVESTIGATOR
John T La
Mobley Clinical Research Center
STUDY DIRECTOR

Enrollment

20 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 11, 2008

First Posted

June 18, 2008

Study Start

April 2008

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Heating Garment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Heating Garment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations