Clinical trial NCT02019030: Treatment of Symptomatic BPH Patients Undergoing Anticoagulant Therapy Using the PlasmaButton Vaporization Electrode
Official title: Treatment of Symptomatic BPH Patients Undergoing Anticoagulant Therapy Using the PlasmaButton Vaporization Electrode - An Observational Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Benign Prostatic Hyperplasia
Keywords: benign prostatic hyperplasia
Transurethral vaporization of prostate
Lead sponsor: Olympus Corporation of the Americas
Sponsor class: INDUSTRY
Collaborators: name: Loma Linda University
name: VA Greater Los Angeles Healthcare System
First posted: 2013-12-24
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.


Eligibility 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.

Primary outcomes:
measure: Complication rates when the PlasmaButton Electrode is used to perform TUVP (Transurethral Vaporization of the Prostate) on patients on anticoagulants
timeFrame: Introperative
Secondary outcomes:
measure: Assessment of subjective patient improvement on the International Prostate Symptom Score questionnaire
timeFrame: Before surgery and 1, 3, 6 month follow up visits
measure: Assessment of subjective patient improvement on the Sexual Health Inventory for Men (SHIM) score
timeFrame: Before surgery and 1, 3, 6 month follow-up
measure: Measurement of maximum urine flow rate as measured by urine flowmetry
timeFrame: Before surgery and 1, 3, 6 month follow-up
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center Urology Department
state: California
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System
state: California
Study officials:
affiliation: Loma Linda University Medical Center
name: Edmund Ko, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Greater Los Angeles Healthcare System
name: Carol J Bennett, MD
role: PRINCIPAL_INVESTIGATOR
References: