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

NCT02019030 | Terminated

• 1 other identifier: 5130322
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 2

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.

Conditions

Benign Prostatic Hyperplasia

Keywords

benign prostatic hyperplasia; Transurethral vaporization of prostate

Outcome Measures

Primary Outcomes (1)

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

  Introperative

Secondary Outcomes (3)

• Assessment of subjective patient improvement on the International Prostate Symptom Score questionnaire

  Before surgery and 1, 3, 6 month follow up visits

• Assessment of subjective patient improvement on the Sexual Health Inventory for Men (SHIM) score

  Before surgery and 1, 3, 6 month follow-up

• Measurement of maximum urine flow rate as measured by urine flowmetry

  Before surgery and 1, 3, 6 month follow-up

Study Arms (1)

BPH on anticoagulation

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Olympus Corporation of the Americas: lead
• Loma Linda University: collaborator
• VA Greater Los Angeles Healthcare System: collaborator

Study Sites (2)

Loma Linda University Medical Center Urology Department

Loma Linda, California, 92354, United States

Location

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Edmund Ko, MD

  Loma Linda University Medical Center

  PRINCIPAL INVESTIGATOR

• Carol J Bennett, MD

  VA Greater Los Angeles Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2013
• First Posted: December 24, 2013
• Study Start: December 1, 2013
• Primary Completion: January 3, 2017
• Study Completion: January 3, 2017
• Last Updated: April 4, 2018

Record last verified: 2018-04

Locations

US (2)