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NCT02019030 Clinical Trial

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
Secondary ID
Status Terminated
Phase
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
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