Bladder Outlet Obstruction Observation Using Dynamic Urine Vibration "Holter"

NCT01779349 | Suspended DMC

• 1 other identifier: PSM - 005
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief 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 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

Keywords

benign prostatic hyperplasia (BPH); acoustic vibration

Outcome Measures

Primary Outcomes (1)

• Efficacy of Holter to confirm or exclude of bladder outlet obstruction

  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.

  One recording at the time of urodynamic testing. (approximatly one minute)

Study Arms (1)

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

Device: Dynamic Urine Vibration "Holter"

Interventions

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

Dynamic Urine Vibration "Holter"

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• P. Square Medical Ltd: lead

Study Sites (2)

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Urinary Bladder Neck Obstruction; Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Male Urogenital Diseases; Prostatic Diseases; Genital Diseases, Male; Genital Diseases

Study Officials

• Haim Matzkin, Prof.

  Urology Department Director, Tel Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2013
• First Posted: January 30, 2013
• Study Start: July 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 31, 2014

Record last verified: 2014-10

Locations

IL (2)