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Clinical Trials/NCT02019030
NCT02019030TerminatedNot Applicable

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

Olympus Corporation of the Americas2 sites in 1 country5 target enrollmentStarted: December 2013Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
5
Locations
2
Primary Endpoint
Complication rates when the PlasmaButton Electrode is used to perform TUVP (Transurethral Vaporization of the Prostate) on patients on anticoagulants
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

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
  • •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.

Outcomes

Primary Outcomes

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

Time Frame: Introperative

Secondary Outcomes

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

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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