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

N/ACompletedNCT02031653

Samsung Medical Center335 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

335

Conditions

Bladder Outlet Obstruction Pressure Flow Study

Eligibility

Sex: MALEMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Outcomes

Primary Outcomes

The Positive/Negative Predictive Value of Penile cuff test

Time frame: 5 hours

The proportion comparison of Good responder between obstructed and unobstructed patients in penile cuff test

good responder: The reduction in the International Prostatic Symptom Scores of more than 50% from the initial scores 3 months after operation.

Time frame: up to 3 months

Secondary Outcomes

The correlation of intra-vesical Pressure between Pressure flow study and penile cuff test

Time frame: 5 hours

The difference of Pain visual analogue scale score between two diagnostic tests

Time frame: 5 hours

The categorical change of penile cuff test normogram after BPH operation

Time frame: up to 3 months

The PSA level change after benign prostatic hyperplasia operation in obstructed and non-obstructed patients.

Time frame: up to 3 months .

The changes of International Prostatic Symptom Scores after BPH operation.

Time frame: up to 3 months