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

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-11
• Study First Submitted QC: 2013-12-17
• Study First Posted: 2013-12-24
• Primary Completion: 2017-01-03
• Study Completion: 2017-01-03
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-03
• Last Update Posted: 2018-04-04

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