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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2014 by Samsung Medical Center.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
KYU-SUNG LEE, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT02031653
First received: January 8, 2014
Last updated: February 12, 2015
Last verified: January 2014
  Purpose

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

Condition
Bladder Outlet Obstruction
Pressure Flow Study

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 193
Study Start Date: January 2014
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Study Group

  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male patients with Low Urinary Tract Symptoms over 6 months.
Criteria

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

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02031653

Locations
Korea, Republic of
Samsung Medical Center
Seoul,, Korea, Republic of, 130-710
Sponsors and Collaborators
Samsung Medical Center
  More Information

Responsible Party: KYU-SUNG LEE, professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02031653     History of Changes
Other Study ID Numbers: 2013-07-151 
Study First Received: January 8, 2014
Last Updated: February 12, 2015

Keywords provided by Samsung Medical Center:
Penile Cuff Test

Additional relevant MeSH terms:
Urinary Bladder Neck Obstruction
Urethral Obstruction
Urethral Diseases
Urologic Diseases
Urinary Bladder Diseases

ClinicalTrials.gov processed this record on January 19, 2017