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

Benign Prostatic Hyperplasia Clinical Trial

Official title:

Treatment of Symptomatic BPH Patients Undergoing Anticoagulant Therapy Using the PlasmaButton Vaporization Electrode - An Observational Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02019030
• Other study ID #: 5130322
• Status: Terminated
• First received: December 11, 2013
• Last updated: April 3, 2018
• Start date: December 2013
• Est. completion date: January 3, 2017

Study information

• Verified date: April 2018
• Source: Olympus Corporation of the Americas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 3, 2017
• Est. primary completion date: January 3, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Locations

Country	Name	City	State
United States	Loma Linda University Medical Center Urology Department	Loma Linda	California
United States	VA Greater Los Angeles Healthcare System	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
Olympus Corporation of the Americas	Loma Linda University, VA Greater Los Angeles Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication rates when the PlasmaButton Electrode is used to perform TUVP (Transurethral Vaporization of the Prostate) on patients on anticoagulants		Introperative
Secondary	Assessment of subjective patient improvement on the International Prostate Symptom Score questionnaire		Before surgery and 1, 3, 6 month follow up visits
Secondary	Assessment of subjective patient improvement on the Sexual Health Inventory for Men (SHIM) score		Before surgery and 1, 3, 6 month follow-up
Secondary	Measurement of maximum urine flow rate as measured by urine flowmetry		Before surgery and 1, 3, 6 month follow-up