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

Samsung Medical Center

Status: Completed

Conditions: Pressure Flow Study; Bladder Outlet Obstruction

Study type: Observational

Funder types: Other

Identifiers

NCT02031653

2013-07-151

Details and patient eligibility

About

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

Enrollment: 335 patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

335 participants in 1 patient group

Study Group