Bladder Outlet Obstruction Observation Using Dynamic Urine Vibration "Holter"

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by P. Square Medical Ltd
Sponsor:
Information provided by (Responsible Party):
P. Square Medical Ltd
ClinicalTrials.gov Identifier:
NCT01779349
First received: January 28, 2013
Last updated: October 20, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Bladder Outlet Obstruction
Device: Dynamic Urine Vibration "Holter"

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Bladder Outlet Obstruction Observation Using Dynamic Urine Vibration "Holter" With Correlation to Pressure Flow Study and Uroflowmetry.

Resource links provided by NLM:


Further study details as provided by P. Square Medical Ltd:

Primary Outcome Measures:
  • Efficacy of Holter to confirm or exclude of bladder outlet obstruction [ Time Frame: One recording at the time of urodynamic testing. (approximatly one minute) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy of Holter to supply the free flowmetry test curve & values. [ Time Frame: One recording at the time of urodynamic testing. (approximatly one minute) ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: July 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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"
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

Any condition which, in the investigator opinion, makes the patient unsuitable

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01779349

Locations
Israel
Hadassah Medical Center Not yet recruiting
Jerusalem, Israel, 91120
Contact: Dov Pode, Prof.    0507874282    rdovp@hadassah.org.il   
Contact: Dov Pode, Prof.    026776518    rdovp@hadassah.org.il   
Principal Investigator: Dov Pode, Prof.         
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Contact: Haim Matzkin, Prof.    +97236973309    hmatzkin@tasmc.health.gov.il   
Principal Investigator: Haim Matzkin, Prof.         
Sponsors and Collaborators
P. Square Medical Ltd
Investigators
Principal Investigator: Haim Matzkin, Prof. Urology Department Director, Tel Aviv Sourasky Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: P. Square Medical Ltd
ClinicalTrials.gov Identifier: NCT01779349     History of Changes
Other Study ID Numbers: PSM - 005
Study First Received: January 28, 2013
Last Updated: October 20, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by P. Square Medical Ltd:
benign prostatic hyperplasia (BPH)
acoustic vibration

Additional relevant MeSH terms:
Urinary Bladder Neck Obstruction
Urethral Obstruction
Urethral Diseases
Urologic Diseases
Urinary Bladder Diseases

ClinicalTrials.gov processed this record on July 24, 2014