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

This study has been terminated.
(Not meeting enrollment goals)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02019030
First Posted: December 24, 2013
Last Update Posted: April 28, 2017
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.
Collaborators:
Loma Linda University
VA Greater Los Angeles Healthcare System
Information provided by (Responsible Party):
Olympus Corporation of the Americas
  Purpose
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
Benign Prostatic Hyperplasia

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Olympus Corporation of the Americas:

Primary Outcome Measures:
  • 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:
  • Assessment of subjective patient improvement on the International Prostate Symptom Score questionnaire [ Time Frame: Before surgery and 1, 3, 6 month follow up visits ]
  • 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 ]
  • Measurement of maximum urine flow rate as measured by urine flowmetry [ Time Frame: Before surgery and 1, 3, 6 month follow-up ]

Enrollment: 5
Actual Study Start Date: December 2013
Study Completion Date: January 3, 2017
Primary Completion Date: January 3, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
BPH on anticoagulation
Patients with Benign Prostatic Hyperplasia (BPH) undergoing Transurethral Vaporization of Prostate and are on anticoagulant medication

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
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
Principal Investigator: Edmund Ko, MD Loma Linda University Medical Center
Principal Investigator: Carol J Bennett, MD VA Greater Los Angeles Healthcare System
  More Information

Responsible Party: Olympus Corporation of the Americas
ClinicalTrials.gov Identifier: NCT02019030     History of Changes
Other Study ID Numbers: 5130322
First Submitted: December 11, 2013
First Posted: December 24, 2013
Last Update Posted: April 28, 2017
Last Verified: April 2017

Keywords provided by Olympus Corporation of the Americas:
benign prostatic hyperplasia
Transurethral vaporization of prostate

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Anticoagulants