Bladder Outlet ObstructionNCT01779349
Bladder Outlet Obstruction Observation Using Dynamic Urine Vibration "Holter"
A study testing Dynamic Urine Vibration "Holter" in people with Bladder Outlet Obstruction, run by P. Square Medical Ltd at 2 sites in Israel.
Trial summary
Current gold standard of bladder outlet diagnosis is pressure flow study. This study is invasive time consuming and requires expensive and complex set-up. In this study the investigators plan to evaluate an alternative technology that presumably is able to diagnose bladder outlet obstruction using a Dynamic Urine… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Bladder Outlet Obstruction
- What is being tested?
- Dynamic Urine Vibration "Holter"
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesIsrael
- Study dates
- Jul 2013to Jun 2015
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of benign prostatic hyperplasia (BPH)
- has indication for urodynamic evaluation
- Males 18 years and older
- Capability of understanding and having signed the informed consent form after full discussion of the research, nature of the treatment, and its risks and benefits.
Who cannot join
- Any condition which, in the investigator opinion, makes the patient unsuitable
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Hadassah Medical Center
Jerusalem, 91120
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
About this study
Official title: Bladder Outlet Obstruction Observation Using Dynamic Urine Vibration "Holter" With Correlation to Pressure Flow Study and Uroflowmetry.
Current gold standard of bladder outlet diagnosis is pressure flow study. This study is invasive time consuming and requires expensive and complex set-up. In this study the investigators plan to evaluate an alternative technology that presumably is able to diagnose bladder outlet obstruction using a Dynamic Urine Vibration "Holter" based on a Urine Flow Vibration Analysis technology. The acoustic vibration sensor is a small device that records the vibration due to urine flow. The patient attaches the sensor to the penis using a disposable sensor patch for the duration of approximately one minute during one urination. The analysis is performed off-line and the results are compared to the results of a standard pressure flow study and to the standard free flowmetry test. The innovative technology for the diagnosis of bladder outlet obstruction is noninvasive, rapid and does not involve complex setup.
- Conditions
- Bladder Outlet Obstruction
- Being tested
- Dynamic Urine Vibration "Holter"
- Keywords
- benign prostatic hyperplasia (BPH), acoustic vibration
- Medical subject headings
- Urinary Bladder Neck Obstruction, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Urine Vibration "Holter"Device
each subject will undergo intervention for the diagnosis of bladder outlet obstruction first using the Dynamic Urine Vibration "Holter" and then urodynamically by pressure flow study
| Study group | Role | What they receive |
|---|---|---|
| Dynamic Urine Vibration "Holter" | Experimental | each subject will undergo intervention for the diagnosis of bladder outlet obstruction first using the Dynamic Urine Vibration "Holter" and then urodynamically by pressure flow study Receives: Device: Dynamic Urine Vibration "Holter" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Holter to confirm or exclude of bladder outlet obstruction
Measured: One recording at the time of urodynamic testing. (approximatly one minute)
Secondary outcomes (1)
Efficacy of Holter to supply the free flowmetry test curve & values.
Measured: One recording at the time of urodynamic testing. (approximatly one minute)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Why it stopped: sensor calibration and other R\&D activities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Outlet ObstructionStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- P. Square Medical Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Haim Matzkin, Prof., Principal investigator, Urology Department Director, Tel Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779349
- Sponsor's protocol ID
- PSM - 005
- Status last verified
- Oct 2014
- First submitted
- 28 Jan 2013
- Last updated
- 31 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bladder Outlet Obstruction Observation Using Dynamic Urine Vibration "Holter" With Correlation to Pressure Flow Study and Uroflowmetry.
- ClinicalTrials.gov ID
- NCT01779349
- Acronym / sponsor ID
- PSM - 005
- Conditions
- Bladder Outlet Obstruction
- Keywords
- benign prostatic hyperplasia (BPH), acoustic vibration
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: sensor calibration and other R\&D activities
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- P. Square Medical LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 30 Jan 2013 (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.
Current gold standard of bladder outlet diagnosis is pressure flow study. This study is invasive time consuming and requires expensive and complex set-up. In this study the investigators plan to evaluate an alternative technology that presumably is able to diagnose bladder outlet obstruction using a Dynamic Urine Vibration "Holter" based on a Urine Flow Vibration Analysis technology. The acoustic vibration sensor is a small device that records the vibration due to urine flow. The patient attaches the sensor to the penis using a disposable sensor patch for the duration of approximately one minute during one urination. The analysis is performed off-line and the results are compared to the results of a standard pressure flow study and to the standard free flowmetry test. The innovative technology for the diagnosis of bladder outlet obstruction is noninvasive, rapid and does not involve complex setup.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dynamic Urine Vibration "Holter" | Experimental | Device: Dynamic Urine Vibration "Holter"each subject will undergo intervention for the diagnosis of bladder outlet obstruction first using the Dynamic Urine Vibration "Holter" and then urodynamically by pressure flow study |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- clinical diagnosis of benign prostatic hyperplasia (BPH)
- has indication for urodynamic evaluation
- Males 18 years and older
- Capability of understanding and having signed the informed consent form after full discussion of the research, nature of the treatment, and its risks and benefits.
Key exclusion criteria (1 listed)
- Any condition which, in the investigator opinion, makes the patient unsuitable
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 |
|---|---|---|
| Dynamic Urine Vibration "Holter"each subject will undergo intervention for the diagnosis of bladder outlet obstruction first using the Dynamic Urine Vibration "Holter" and then urodynamically by pressure flow study | Device | Dynamic Urine Vibration "Holter" |
Primary outcome
Efficacy of Holter to confirm or exclude of bladder outlet obstruction
Time frame: One recording at the time of urodynamic testing. (approximatly one minute)
1 secondary outcome
Efficacy of Holter to supply the free flowmetry test curve & values.
Time frame: One recording at the time of urodynamic testing. (approximatly one minute)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2014.
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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.
Haim Matzkin, Prof. principal investigator
Urology Department Director, Tel Aviv Sourasky Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Urine Vibration "Holter" in people with Bladder Outlet Obstruction, run by P. Square Medical Ltd at 2 sites in Israel.
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 4 inclusion and 1 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: paused, as of the sponsor's last update on 31 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
Results are not available in the source record.
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?
Efficacy of Holter to confirm or exclude of bladder outlet obstruction (time frame: One recording at the time of urodynamic testing. (approximatly one minute)). 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 31 Oct 2014.