Benign Prostatic Hyperplasia (BPH)NCT00700505
A Study to Determine the Safety and Efficacy of a New Non-invasive Heating Garment to Reduce Urinary Hesitancy
A study testing FlowPants(R) Garment in people with Benign Prostatic Hyperplasia (BPH) and Urinary Retention, run by ThermaRx, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 25 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia (BPH), Urinary Retention, Urinary Hesitancy Intermittent
- What is being tested?
- FlowPants(R) Garment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Urine retention (inability to urinate)
- Hesitant, interrupter or weak stream of urine
- Inability or difficulty to urinate in public
Who cannot join
- History of prostate cancer or prostate surgery
- Currently (or within the past 30 days) on active treatment for prostate problems
Trial locations and contacts
1 site in 1 country.
United States1 site
Mobley Clinical Research Center
Houston, Texas, 77024
About this study
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).
Read the 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.
- Being tested
- FlowPants(R) Garment
- Keywords
- Benign Prostatic Hyperplasia, BPH, Benign Prostatic Hypertrophy, Urinary Retention, Shy Bladder, Urinary Hesitancy, Bashful Bladder, Paruresis
- Medical subject headings
- Prostatic Hyperplasia, Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Heating Garment | Experimental | FlowPants(R) Garment with Heating Receives: Device: FlowPants(R) Garment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-void residual urinary volume (PVR)
Measured: 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
Measured: Both Study Day 1 & 2 before/after oral fluid load
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startApr 2008
- Primary completionOct 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic Hyperplasia (BPH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- ThermaRx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Mobley, M.D., Principal investigator, Mobley Clinical Research CenterJohn T La, Study director, Mobley Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00700505
- Sponsor's protocol ID
- TR-DM-001
- Status last verified
- Aug 2012
- First submitted
- 11 Jun 2008
- Last updated
- 14 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine the Safety and Efficacy of a New Non-invasive Heating Garment to Reduce Urinary Hesitancy
- ClinicalTrials.gov ID
- NCT00700505
- Acronym / sponsor ID
- TR-DM-001
- Keywords
- Benign Prostatic Hyperplasia, BPH, Benign Prostatic Hypertrophy, Urinary Retention, Shy Bladder, Urinary Hesitancy, Bashful Bladder, Paruresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ThermaRx, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 18 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heating Garment | Experimental | Device: FlowPants(R) GarmentFlowPants(R) Garment with Heating |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- History of prostate cancer or prostate surgery
- Currently (or within the past 30 days) on active treatment for prostate problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlowPants(R) GarmentThe 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. | Device | Heating Garment |
Primary outcome
Post-void residual urinary volume (PVR)
Time frame: Both Study Day 1 & 2 before/after oral fluid load
1 secondary outcome
Voided volume percentage (%) based on pre-void and post-void ultrasound volumes
Time frame: Both Study Day 1 & 2 before/after oral fluid load
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2012.
- Heat TherapyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Mobley, M.D. principal investigator
Mobley Clinical Research Center
John T La study director
Mobley Clinical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FlowPants(R) Garment in people with Benign Prostatic Hyperplasia (BPH) and Urinary Retention, run by ThermaRx, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-void residual urinary volume (PVR) (time frame: Both Study Day 1 & 2 before/after oral fluid load). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2012.