An observational study in Bladder Outlet Obstruction and Pressure Flow Study, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to male participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2019-12-02.
Sponsored by Samsung Medical Center · Observational
To provide evidence of promising tests to noninvasively diagnose bladder outlet obstruction (BOO) in men with benign prostatic hyperplasia.
46 studies on the registry are indexed under Urinary Bladder Neck Obstruction; 10 are open to participants now.
This study's enrollment of 335 is above the median of 165 across 14 observational studies indexed under Urinary Bladder Neck Obstruction.
Browse Urinary Bladder Neck Obstruction studies →Samsung Medical Center is the lead sponsor of 1,011 studies on the registry; 152 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Male patients with Low Urinary Tract Symptoms over 6 months.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
good responder: The reduction in the International Prostatic Symptom Scores of more than 50% from the initial scores 3 months after operation.
Time frame: up to 3 months
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
The record gives a start of Jan 2014, a primary completion of Jul 2017 and a completion of Dec 2017. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Urinary Bladder Neck Obstruction →