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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02019030

Enrollment

Registered

2013-12-24

Start date

2013-12-31

Completion date

2017-01-03

Last updated

2018-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia

Keywords

benign prostatic hyperplasia, Transurethral vaporization of prostate

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

United States

Outcome results