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

NCT02031653 | Completed

• 1 other identifier: 2013-07-151
• Study Type: observational
• Target: 335
• Locations: 1 country
• Sites: 1

Brief Summary

To provide evidence of promising tests to noninvasively diagnose bladder outlet obstruction (BOO) in men with benign prostatic hyperplasia.

1. 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. 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

Conditions

Bladder Outlet Obstruction; Pressure Flow Study

Keywords

Penile Cuff Test

Outcome Measures

Primary Outcomes (2)

• The Positive/Negative Predictive Value of Penile cuff test

  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.

  up to 3 months

Secondary Outcomes (5)

• The correlation of intra-vesical Pressure between Pressure flow study and penile cuff test

  5 hours

• The difference of Pain visual analogue scale score between two diagnostic tests

  5 hours

• The categorical change of penile cuff test normogram after BPH operation

  up to 3 months

• The PSA level change after benign prostatic hyperplasia operation in obstructed and non-obstructed patients.

  up to 3 months .

• The changes of International Prostatic Symptom Scores after BPH operation.

  up to 3 months

Study Arms (1)

Study Group

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male patients with Low Urinary Tract Symptoms over 6 months.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 130-710, South Korea

Location

MeSH Terms

Conditions

Urinary Bladder Neck Obstruction

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: January 9, 2014
• Study Start: January 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 2, 2019

Record last verified: 2019-11

Locations

KR (1)