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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by Olympus Corporation of the Americas
Sponsor:
Collaborator:
Loma Linda University
Information provided by (Responsible Party):
Olympus Corporation of the Americas
ClinicalTrials.gov Identifier:
NCT02019030
First received: December 11, 2013
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

The purpose of this observational study is to evaluate the outcomes of using the PlasmaButton electrode in the treatment on Benign Prostatic Hyperplasia 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 ransurethral Vaporization of the Prostate) on patients on anticoagulants [ Time Frame: Introperative ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
  • Assessment of subjective patient improvement on the Sexual Health for Men (SHIM) score [ Time Frame: Before surgery and 1, 3, 6 month follow-up ] [ Designated as safety issue: No ]
  • Measurement of maximum urine flow rate as measured by urine flowmetry [ Time Frame: Before surgery and 1, 3, 6 month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: December 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Benign prostatic hyperplasia, anticoagulation
Patients who have Benign Prostatic Hyperplasia undergoing Transurethral Vaporization of Prostate and are on anticoagulant medication

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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 regiment.
  • 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02019030

Contacts
Contact: David Hadley, MD. 909-558-4000 ext 44196 davidhadley@llu.edu

Locations
United States, California
Loma Linda University Medical Center Urology Department Not yet recruiting
Loma Linda, California, United States, 92354
Principal Investigator: David Hadley, MD.         
Sub-Investigator: Herbert C. Ruckle, MD.         
Sub-Investigator: Edmund Ko, MD.         
VA Greater Los Angeles Healthcare System Not yet recruiting
Los Angeles, California, United States, 90073
Principal Investigator: Carol J Bennett, MD         
Sponsors and Collaborators
Olympus Corporation of the Americas
Loma Linda University
Investigators
Principal Investigator: David Hadley, MD. Loma Linda University Medical Center
Principal Investigator: Carol J Bennett, MD VA Greater Los Angeles Healthcare System
  More Information

No publications provided

Responsible Party: Olympus Corporation of the Americas
ClinicalTrials.gov Identifier: NCT02019030     History of Changes
Other Study ID Numbers: 5130322
Study First Received: December 11, 2013
Last Updated: December 17, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014