Comparison Between Invasive Pressure Flow Study and Non-invasive Penile Cuff Test
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|ClinicalTrials.gov Identifier: NCT02031653|
Recruitment Status : Unknown
Verified January 2014 by KYU-SUNG LEE, Samsung Medical Center.
Recruitment status was: Recruiting
First Posted : January 9, 2014
Last Update Posted : February 16, 2015
To provide evidence of promising tests to noninvasively diagnose bladder outlet obstruction (BOO) in men with benign prostatic hyperplasia.
- 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.
- 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
|Condition or disease|
|Bladder Outlet Obstruction Pressure Flow Study|
|Study Type :||Observational|
|Estimated Enrollment :||193 participants|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||July 2015|
- The Positive/Negative Predictive Value of Penile cuff test [ Time Frame: 5 hours ]
- The proportion comparison of Good responder between obstructed and unobstructed patients in penile cuff test [ Time Frame: 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.
- The correlation of intra-vesical Pressure between Pressure flow study and penile cuff test [ Time Frame: 5 hours ]
- The difference of Pain visual analogue scale score between two diagnostic tests [ Time Frame: 5 hours ]
- The categorical change of penile cuff test normogram after BPH operation [ Time Frame: up to 3 months ]
- The PSA level change after benign prostatic hyperplasia operation in obstructed and non-obstructed patients. [ Time Frame: up to 3 months . ]
- The changes of International Prostatic Symptom Scores after BPH operation. [ Time Frame: up to 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02031653
|Contact: Kyu-Sung Lee, Ph.D, M.D.||firstname.lastname@example.org|
|Korea, Republic of|
|Samsung Medical Center||Recruiting|
|Seoul,, Korea, Republic of, 130-710|
|Contact: Hyun Wook You, M.D. 82-2-3410-1268 email@example.com|
|Principal Investigator: Kyu-Sung Lee, Ph.D, M.D.|