Bladder Outlet ObstructionNCT01388348
Diagnosis of Bladder Outlet Obstruction Using Dynamic Urine Vibration "Holter" in Comparison to Pressure Flow Study
A study testing Dynamic Urine Vibration "Holter" in people with Bladder Outlet Obstruction, run by Meir Medical Center at 1 site 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
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2011to Dec 2011
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Meir Medical Center
Kfar Saba, 44281
ilan leibovitch, md, +97297471557, leibovitchi@clalit.org.il
ilan leibovitch, MD
About this study
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. 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01388348
- Sponsor's protocol ID
- mmc 022-2011
- Status last verified
- Jul 2011
- First submitted
- 15 Feb 2011
- Last updated
- 6 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Bladder Outlet Obstruction Using Dynamic Urine Vibration "Holter" in Comparison to Pressure Flow Study
- ClinicalTrials.gov ID
- NCT01388348
- Acronym / sponsor ID
- mmc 022-2011
- Conditions
- Bladder Outlet Obstruction
- Keywords
- benign prostatic hyperplasia (BPH), acoustic vibration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 6 Jul 2011 (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. 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
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- 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 (2 listed)
- clinical diagnosis of benign prostatic hyperplasia (BPH)
- has indication for urodynamic evaluation
Key exclusion criteria (0 listed)
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2011.
Related trials for Bladder Outlet Obstruction
Not yet recruiting
High Intensity Focused Ultrasound (HIFU) Ablation for Treatment of Prostate Tissue in Bladder Outlet Obstruction
Bladder Outlet Obstruction, BPH
RecruitingPhase 1
Imaging Study of [89Zr]DFO-YS5 for Cancer Detection
Bladder Cancer, Nerve Sheath Tumor
RecruitingEarly Phase 1
Concomitant Renal and Urinary Bladder Allograft Transplantation
Chronic Kidney Diseases, Bladder Dysfunction
RecruitingObservational study
Effect of Catheter Duration on Prostate Laser Enucleation Surgery Outcomes in Patients With Urinary Retention
Urinary Retention, Benign Prostate Obstruction (BPO)
Not yet recruiting
Thulium Laser Enucleation With Bladder Neck Incision for Small-Volume Benign Prostatic Hyperplasia
Benign Prostatic Hyperplasia, Bladder Outlet Obstruction
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.
1 site 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 Meir Medical Center at 1 site 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 2 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 6 Jul 2011. 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 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?
Contact Ilan Leibovitch, MD (+97297471557, leibovitchi@clalit.org.il), or a site near the patient. 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 6 Jul 2011.