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

Completed

• Conditions: Bladder Outlet Obstruction; Pressure Flow Study

• Registration Number: NCT02031653
• Lead Sponsor: Samsung Medical Center

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-08
• Study First Submitted QC: 2014-01-08
• Study First Posted: 2014-01-09
• Primary Completion: 2017-07
• Study Completion: 2017-12
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-28
• Last Update Posted: 2019-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 335

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The correlation of intra-vesical Pressure between Pressure flow study and penile cuff test	5 hours
The categorical change of penile cuff test normogram after BPH operation	up to 3 months
The difference of Pain visual analogue scale score between two diagnostic tests	5 hours
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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul,, Korea, Republic of