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