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Completed

NCT Number: NCT02031653

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

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

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Key information

Conditions

Bladder Outlet Obstruction Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pressure Flow Study Urethral Diseases Urethral Obstruction Urinary Bladder Diseases Urinary Bladder Neck Obstruction Urogenital Diseases Urologic Diseases

Age range

40 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Samsung Medical Center

Seoul, 130-710, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. The Positive/Negative Predictive Value of Penile cuff test

    Time frame: 5 hours

  2. 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 outcomes

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

    Time frame: 5 hours

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

    Time frame: 5 hours

  3. The categorical change of penile cuff test normogram after BPH operation

    Time frame: up to 3 months

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

    Time frame: up to 3 months .

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

    Time frame: up to 3 months

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 9, 2014
Registry last updated
Dec 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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