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

Bladder Outlet Obstruction Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02031653
• Other study ID #: 2013-07-151
• Status: Completed
• Start date: January 2014
• Est. completion date: December 2017

Study information

• Verified date: November 2019
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 335
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Outlet Obstruction
• Pressure Flow Study
• Urinary Bladder Neck Obstruction

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul,

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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