Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02019030
Recruitment Status : Terminated (Not meeting enrollment goals)
First Posted : December 24, 2013
Last Update Posted : April 4, 2018
Sponsor:
Collaborators:
Loma Linda University
VA Greater Los Angeles Healthcare System
Information provided by (Responsible Party):
Olympus Corporation of the Americas

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease
Benign Prostatic Hyperplasia

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Treatment of Symptomatic BPH Patients Undergoing Anticoagulant Therapy Using the PlasmaButton Vaporization Electrode - An Observational Study
Actual Study Start Date : December 2013
Actual Primary Completion Date : January 3, 2017
Actual Study Completion Date : January 3, 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Complication rates when the PlasmaButton Electrode is used to perform TUVP (Transurethral Vaporization of the Prostate) on patients on anticoagulants [ Time Frame: Introperative ]

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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02019030


Locations
Layout table for location information
United States, California
Loma Linda University Medical Center Urology Department
Loma Linda, California, United States, 92354
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States, 90073
Sponsors and Collaborators
Olympus Corporation of the Americas
Loma Linda University
VA Greater Los Angeles Healthcare System
Investigators
Layout table for investigator information
Principal Investigator: Edmund Ko, MD Loma Linda University Medical Center
Principal Investigator: Carol J Bennett, MD VA Greater Los Angeles Healthcare System
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Olympus Corporation of the Americas
ClinicalTrials.gov Identifier: NCT02019030    
Other Study ID Numbers: 5130322
First Posted: December 24, 2013    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018
Keywords provided by Olympus Corporation of the Americas:
benign prostatic hyperplasia
Transurethral vaporization of prostate
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases