Treatment of Symptomatic BPH Patients Undergoing Anticoagulant Therapy Using the PlasmaButton Vaporization Electrode
Terminated
- Conditions
- Benign Prostatic Hyperplasia
- Registration Number
- NCT02019030
- Lead Sponsor
- Olympus Corporation of the Americas
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 5
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complication rates when the PlasmaButton Electrode is used to perform TUVP (Transurethral Vaporization of the Prostate) on patients on anticoagulants Introperative
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
Loma Linda University Medical Center Urology Department
🇺🇸Loma Linda, California, United States
VA Greater Los Angeles Healthcare System
🇺🇸Los Angeles, California, United States
Loma Linda University Medical Center Urology Department🇺🇸Loma Linda, California, United States