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

Olympus

Status: Terminated

Conditions: Benign Prostatic Hyperplasia

Study type: Observational

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT02019030

5130322

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

5 participants in 1 patient group

BPH on anticoagulation

Description:

Patients with Benign Prostatic Hyperplasia (BPH) undergoing Transurethral Vaporization of Prostate and are on anticoagulant medication