An interventional study of Dynamic Urine Vibration "Holter" in Bladder Outlet Obstruction, sponsored by P. Square Medical Ltd. Suspended at 2 sites in Israel. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-10-31.
Sponsored by P. Square Medical Ltd · Not applicable, Interventional, and Diagnostic
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.
46 studies on the registry are indexed under Urinary Bladder Neck Obstruction; 10 are open to participants now.
This study's planned enrollment of 45 is below the median of 88 across 30 interventional studies indexed under Urinary Bladder Neck Obstruction.
Browse Urinary Bladder Neck Obstruction studies →This is the only study on the registry with P. Square Medical Ltd as lead sponsor.
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Exclusion Criteria:
Any condition which, in the investigator opinion, makes the patient unsuitable
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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"
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
Efficacy of Holter to confirm or exclude of bladder outlet obstruction
Time frame: One recording at the time of urodynamic testing. (approximatly one minute)
Efficacy of Holter to supply the free flowmetry test curve & values.
Time frame: One recording at the time of urodynamic testing. (approximatly one minute)
The record gives a start of Jul 2013, a primary completion of Jun 2015 and a completion of Jun 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is suspended, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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Urinary Bladder Neck Obstruction →