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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02031653

Enrollment

335

Registered

2014-01-09

Start date

2014-01-31

Completion date

2017-12-31

Last updated

2019-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Outlet Obstruction, Pressure Flow Study

Keywords

Penile Cuff Test

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

40 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
The Positive/Negative Predictive Value of Penile cuff test	5 hours	—
The proportion comparison of Good responder between obstructed and unobstructed patients in penile cuff test	up to 3 months	good responder: The reduction in the International Prostatic Symptom Scores of more than 50% from the initial scores 3 months after operation.

Secondary

Measure	Time frame
The categorical change of penile cuff test normogram after BPH operation	up to 3 months
The correlation of intra-vesical Pressure between Pressure flow study and penile cuff test	5 hours
The changes of International Prostatic Symptom Scores after BPH operation.	up to 3 months
The PSA level change after benign prostatic hyperplasia operation in obstructed and non-obstructed patients.	up to 3 months .
The difference of Pain visual analogue scale score between two diagnostic tests	5 hours

Countries

South Korea

Outcome results