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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
KYU-SUNG LEE, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT02031653
First received: January 8, 2014
Last updated: January 9, 2014
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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
  • The proportion comparison of Good responder between obstructed and unobstructed patients in penile cuff test [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • The difference of Pain visual analogue scale score between two diagnostic tests [ Time Frame: 5 hours ] [ Designated as safety issue: No ]
  • The categorical change of penile cuff test normogram after BPH operation [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
  • The PSA level change after benign prostatic hyperplasia operation in obstructed and non-obstructed patients. [ Time Frame: up to 3 months . ] [ Designated as safety issue: No ]
  • The changes of International Prostatic Symptom Scores after BPH operation. [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Kyu-Sung Lee, Ph.D, M.D. 82-2-3410-3554 ksleedr@skku.edu

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul,, Korea, Republic of, 130-710
Contact: Hyun Wook You, M.D.    82-2-3410-1268    khdoct29@gmail.com   
Principal Investigator: Kyu-Sung Lee, Ph.D, M.D.         
Sponsors and Collaborators
Samsung Medical Center
  More Information

No publications provided

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: January 9, 2014
Health Authority: South Korea: Institutional Review Board

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 September 18, 2014