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

NCT00700505 | Completed DMC

• 1 other identifier: TR-DM-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Benign Prostatic Hyperplasia (BPH); Urinary Retention; Urinary Hesitancy Intermittent

Keywords

Benign Prostatic Hyperplasia; BPH; Benign Prostatic Hypertrophy; Urinary Retention; Shy Bladder; Urinary Hesitancy; Bashful Bladder; Paruresis

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) Garment DEVICE

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

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (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).
• 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

You may not qualify if:

• History of prostate cancer or prostate surgery
• Currently (or within the past 30 days) on active treatment for prostate problems

Sponsors & Collaborators

• ThermaRx, Inc.: lead

Study Sites (1)

Mobley Clinical Research Center

Houston, Texas, 77024, United States

Location

Related Links

• Heat Therapy

MeSH Terms

Conditions

Prostatic Hyperplasia; Urinary Retention

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female 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

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 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 14, 2012

Record last verified: 2012-08

Locations

US (1)