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

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 Overview

• Status: Completed
• Conditions: Bladder Outlet Obstruction; Pressure Flow Study

• Study Type: Observational
• Enrollment (Actual): 335

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul,, Korea, Republic of, 130-710
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Male patients with Low Urinary Tract Symptoms over 6 months.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Study Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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 Outcome Measures

Outcome Measure	Time Frame
The correlation of intra-vesical Pressure between Pressure flow study and penile cuff test	5 hours
The difference of Pain visual analogue scale score between two diagnostic tests	5 hours
The categorical change of penile cuff test normogram 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 changes of International Prostatic Symptom Scores after BPH operation.	up to 3 months

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: January 8, 2014
• First Submitted That Met QC Criteria: January 8, 2014
• First Posted (Estimate): January 9, 2014

Study Record Updates

• Last Update Posted (Actual): December 2, 2019
• Last Update Submitted That Met QC Criteria: November 28, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Penile Cuff Test
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Urethral Diseases; Urethral Obstruction; Urinary Bladder Neck Obstruction
• Other Study ID Numbers: 2013-07-151