Treatment of Symptomatic BPH Patients Undergoing Anticoagulant Therapy Using the PlasmaButton Vaporization Electrode

Stopped early

Conditions studied: Benign Prostatic Hyperplasia

In brief

The purpose of this observational study is to evaluate the outcomes of using the PlasmaButton electrode in the treatment on Benign Prostatic Hyperplasia (BPH) while on anticoagulation medication.

Key facts

Study ID

NCT02019030

Run by

Olympus Corporation of the Americas

People needed

5

Starts

2013-12-01

Expected to finish

2017-01-03

Last updated by the study team

2018-04-04

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Men with obstructive symptoms due to benign prostatic hyperplasia who are also on anticoagulant regimen.
• Anticoagulant regiments include: Aspirin 81mg, Aspirin 325mg, Adenosine diphosphate (ADP) receptor inhibitors, Cilostazol, Dabigatran, Dipyridamole, or Warfarin. The patient will be stable on their dosage regimen for at least 3 months.
• Maximum flow rate <15ml/s by uroflowmetry.
• International Prostate Symptom Score (IPSS)≥10.

You may not qualify if…

• Patients with coagulopathy, INR exceeding 3.
• Anti-coagulation dose changes within 3 months of surgery.
• Patients not medically cleared to undergo surgery for medical reasons.
• Patients with neurogenic bladder (bladder affected due to a neurologic cause).
• Urethral stricture, obstruction due to stricture.
• Suspected bladder or prostate cancer.
• Prostate size greater than 80 cc.

Where it is running

• Loma Linda University Medical Center Urology Department — Loma Linda, California, United States
• VA Greater Los Angeles Healthcare System — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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