Enrolling by invitationInterventionalNot ApplicableUpdated Jun 17, 2026
Comparison Between Invasive Pressure Flow Study and Non-invasive Penile Cuff Test | NCT02031653 | Trialant
CompletedObservationalUpdated Dec 2, 2019
Comparison Between Invasive Pressure Flow Study and Non-invasive Penile Cuff Test
ClinicalTrials.gov ID
NCT02031653
Lead Sponsor
Samsung Medical CenterOTHER
Overall Status
Completed
Study Type
Observational
Enrollment
335Actual
Last Update Posted
Dec 2, 2019Actual
Start Date
Jan 2014
Primary Completion Date
Jul 2017Actual
Completion Date
Dec 2017Actual
Brief Summary
To provide evidence of promising tests to noninvasively diagnose bladder outlet obstruction (BOO) in men with benign prostatic hyperplasia.
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.
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
Bladder Outlet Obstruction
Pressure Flow Study
No interventions
There are no interventions for this study.
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male patients with Low Urinary Tract Symptoms over 6 months. (International prostatic symptom score >= 12)
Patients scheduled to have pressure flow study.
Able to give fully informed consent
Exclusion Criteria:
Patients with urologic malignancies such as prostate cancer and bladder cancer
Patients underwent urethral, prostate surgery
Patients with urethral stricture or bladder diverticulum or bladder neck contracture
seems not to be appropriate to this study by the decision of investigators because of any other reasons