ClinicalTrials.gg
Status unknownNCT01388348Updated Jul 6, 2011

Diagnosis of Bladder Outlet Obstruction Using Dynamic Urine Vibration "Holter" in Comparison to Pressure Flow Study

An interventional study of Dynamic Urine Vibration "Holter" in Bladder Outlet Obstruction, sponsored by Meir Medical Center. Status unknown at 1 site in Israel. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-07-06.

Sponsored by Meir Medical Center · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jul 2011), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study 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 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.

02

Conditions studied

  • Bladder Outlet Obstruction

Keywords

  • benign prostatic hyperplasia (BPH)
  • acoustic vibration
03

In context

Urinary Bladder Neck Obstruction

46 studies on the registry are indexed under Urinary Bladder Neck Obstruction; 10 are open to participants now.

This study's planned enrollment of 100 is above the median of 88 across 30 interventional studies indexed under Urinary Bladder Neck Obstruction.

Browse Urinary Bladder Neck Obstruction studies →

Lead sponsor

Meir Medical Center is the lead sponsor of 401 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • clinical diagnosis of benign prostatic hyperplasia (BPH)
  • has indication for urodynamic evaluation
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    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"

Interventions

  • DeviceDynamic 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

06

What researchers measure

Primary outcomes

  1. Efficacy of Holter to confirm or exclude of bladder outlet obstruction

    Time frame: one recording at the time of urodynamic testing.approximatly one minute

07

Study locations

1 site
  • Meir Medical Center
    Kfar Saba, 44281, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01388348
First posted
Jul 6, 2011
Start date
Jul 2011
Primary completion
Dec 2011 (estimated)
Completion
Dec 2011 (estimated)
Last update
Jul 6, 2011

Study contacts

Ilan Leibovitch, MD
Contact
leibovitchi@clalit.org.il
+97297471557

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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