Bladder Outlet ObstructionNCT02031653
Comparison Between Invasive Pressure Flow Study and Non-invasive Penile Cuff Test
An observational study of Bladder Outlet Obstruction and Pressure Flow Study, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Bladder Outlet Obstruction, Pressure Flow Study
- How many people
- 335 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2014to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male patients with Low Urinary Tract Symptoms over 6 months.
Who may be able to join
- Male patients with Low Urinary Tract Symptoms over 6 months. (International prostatic symptom score >= 12)
- Patients scheduled to have pressure flow study.
- Able to give fully informed consent
Who cannot join
- Patients with urologic malignancies such as prostate cancer and bladder cancer
- Patients underwent urethral, prostate surgery
- Patients with urethral stricture or bladder diverticulum or bladder neck contracture
- seems not to be appropriate to this study by the decision of investigators because of any other reasons
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Bladder Outlet Obstruction, Pressure Flow Study
- Keywords
- Penile Cuff Test
- Medical subject headings
- Urinary Bladder Neck Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Positive/Negative Predictive Value of Penile cuff test
Measured: 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.
Measured: up to 3 months
Secondary outcomes (5)
The correlation of intra-vesical Pressure between Pressure flow study and penile cuff test
Measured: 5 hours
The difference of Pain visual analogue scale score between two diagnostic tests
Measured: 5 hours
The categorical change of penile cuff test normogram after BPH operation
Measured: up to 3 months
The PSA level change after benign prostatic hyperplasia operation in obstructed and non-obstructed patients.
Measured: up to 3 months .
The changes of International Prostatic Symptom Scores after BPH operation.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJul 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Outlet ObstructionStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KYU-SUNG LEE, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031653
- Sponsor's protocol ID
- 2013-07-151
- Status last verified
- Nov 2019
- First submitted
- 8 Jan 2014
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Invasive Pressure Flow Study and Non-invasive Penile Cuff Test
- ClinicalTrials.gov ID
- NCT02031653
- Acronym / sponsor ID
- 2013-07-151
- Conditions
- Bladder Outlet Obstruction, Pressure Flow Study
- Keywords
- Penile Cuff Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 9 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients with Low Urinary Tract Symptoms over 6 months.
Key inclusion criteria (3 listed)
- Male patients with Low Urinary Tract Symptoms over 6 months. (International prostatic symptom score >= 12)
- Patients scheduled to have pressure flow study.
- Able to give fully informed consent
Key exclusion criteria (4 listed)
- Patients with urologic malignancies such as prostate cancer and bladder cancer
- Patients underwent urethral, prostate surgery
- Patients with urethral stricture or bladder diverticulum or bladder neck contracture
- seems not to be appropriate to this study by the decision of investigators because of any other reasons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Outlet Obstruction and Pressure Flow Study, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Positive/Negative Predictive Value of Penile cuff test (time frame: 5 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2019.