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

Treatment of Symptomatic BPH Patients Undergoing Anticoagulant Therapy Using the PlasmaButton Vaporization Electrode - An Observational Study

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.

Study Overview

• Status: Terminated
• Conditions: Benign Prostatic Hyperplasia

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center Urology Department
    • Los Angeles, California, United States, 90073
      • VA Greater Los Angeles Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Symptomatic BPH patients seen at Urology clinic at Loma Linda University Medical Center and VA Greater Los Angeles Healthcare System

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
BPH on anticoagulation; Patients with Benign Prostatic Hyperplasia (BPH) undergoing Transurethral Vaporization of Prostate and are on anticoagulant medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Complication rates when the PlasmaButton Electrode is used to perform TUVP (Transurethral Vaporization of the Prostate) on patients on anticoagulants	Introperative

Secondary Outcome Measures

Outcome Measure	Time Frame
Assessment of subjective patient improvement on the International Prostate Symptom Score questionnaire	Before surgery and 1, 3, 6 month follow up visits
Assessment of subjective patient improvement on the Sexual Health Inventory for Men (SHIM) score	Before surgery and 1, 3, 6 month follow-up
Measurement of maximum urine flow rate as measured by urine flowmetry	Before surgery and 1, 3, 6 month follow-up

Collaborators and Investigators

• Sponsor: Olympus Corporation of the Americas
• Collaborators: Loma Linda University; VA Greater Los Angeles Healthcare System
• Investigators: Principal Investigator: Edmund Ko, MD, Loma Linda University Medical Center; Principal Investigator: Carol J Bennett, MD, VA Greater Los Angeles Healthcare System

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Actual): January 3, 2017
• Study Completion (Actual): January 3, 2017

Study Registration Dates

• First Submitted: December 11, 2013
• First Submitted That Met QC Criteria: December 17, 2013
• First Posted (Estimate): December 24, 2013

Study Record Updates

• Last Update Posted (Actual): April 4, 2018
• Last Update Submitted That Met QC Criteria: April 3, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: benign prostatic hyperplasia; Transurethral vaporization of prostate
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: 5130322