Comparison Between Invasive Pressure Flow Study and Non-invasive Penile Cuff Test

NCT ID: NCT02031653

Last Updated: 2019-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

335 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-12-31

Brief Summary

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To provide evidence of promising tests to noninvasively diagnose bladder outlet obstruction (BOO) in men with benign prostatic hyperplasia.

1. Penile cuff test provides a means of obtaining a urodynamic diagnosis with a high level of accuracy without the morbidity and expense of invasive Pressure flow study.
2. Penile cuff test may be particularly useful in the counseling of patients prior to benign prostatic hyperplasia operation. Patients diagnosed as obstructed following a penile cuff test can be reassured that surgery has a high chance of resulting in symptomatic benefit

Detailed Description

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Conditions

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Bladder Outlet Obstruction Pressure Flow Study

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study Group

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Male patients with Low Urinary Tract Symptoms over 6 months. (International prostatic symptom score \>= 12)
2. Patients scheduled to have pressure flow study.
3. Able to give fully informed consent

Exclusion Criteria

1. Patients with urologic malignancies such as prostate cancer and bladder cancer
2. Patients underwent urethral, prostate surgery
3. Patients with urethral stricture or bladder diverticulum or bladder neck contracture
4. seems not to be appropriate to this study by the decision of investigators because of any other reasons
Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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KYU-SUNG LEE

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2013-07-151

Identifier Type: -

Identifier Source: org_study_id

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