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PK Button Vaporization Electrode for Treatment of Bladder Tumors

Phase 4
18 Years
89 Years
Open (Enrolling)
Bladder Cancer

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Trial Information

PK Button Vaporization Electrode for Treatment of Bladder Tumors

This study will study the medical intervention used when bladder cancer patients present
with a new or recurrent bladder tumor. Currently when patients report these tumors, they
undergo a standard practice called transurethral resection of the bladder tumor (TURBT) in
order to determine the stage of the cancer. This intervention, accomplished by looking
through the urethra using an endoscope, is both diagnostic and potentially therapeutic. An
adequately performed TURBT will provide the pathologist with enough tissue to provide tumor
grade and stage information. Currently, TURBT is done using equipment called monopolar
electrocautery which is in the form a 90-degree loop electrode. Although usually safe and
sufficient, this technique can create technical challenges because it can be difficult to
position the loop electrode in a dynamically changing cylindrical space (the bladder).
Specifically, especially with larger bladder tumors, intraoperative bleeding can obscure
visualization and result in incomplete tumor resection as well as inadequate sampling of the
layers of the bladder needed to establish tumor stage. Furthermore, monopolar current can
result in stimulation of a nerve (the obturator nerve) during resection of wall tumors,
resulting in violent movement of the leg which can cause a potential bladder tear as well as
possible (iliac) vessel injury.

Conversely, a technique using bipolar energy, which has been available for many years, has
been readily adopted for the surgical treatment of benign prostatic enlargement. The
advantages of a bipolar electrical current include the direct return of electrical current
to the loop rather than to a grounding pad placed on the patient's skin. This has the
theoretical value of limiting the diffusion of electrical current, and therefore heat, to
the surrounding tissue. A further refinement on bipolar energy has been the recent
introduction of a piece of equipment called the PlasmaKinetic (PK) Button Vaporization
electrode, which is currently approved by the Food and Drug Administration (FDA) for this
indication. Coupling bipolar energy into the Button electrode would not only harness the
benefits of less thermal spread but also would obviate the geometric challenges associated
with loop electrodes during resection of bladder tumors. Procedural advantages would
potentially include minimal bleeding, good visualization, and a reduction in the occurrence
of the obturator reflex and concomitant bladder perforation.

This study is a randomized double-arm trial examining the results of both techniques for
bladder cancer TURBT procedures with a minimum of 120 patients at Emory. The purpose of this
study is to measure the procedural (intraoperative), short term, as clinically indicated
(4-6 weeks), and long-term (3 months) outcomes of TURBT using the PK Button when compared to
traditional monopolar loop electrocautery. The goal of the study will be to prove
equivalence in outcomes between the two techniques.

Inclusion Criteria:

- Patients with cystoscopically detected bladder tumors requiring TURBT

- Patients with bladder tumors which are endoscopically resectable by surgeon's
judgment with only one trip into the operating room.

Exclusion Criteria:

- Patients with clinical evidence of locally advanced, nodal, or metastatic bladder

- Patients with hydronephrosis secondary to bladder cancer

- Patients with diffuse tumor throughout bladder that is deemed unresectable by surgeon

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Procedural complications

Outcome Description:

The primary endpoint will be the measurements of procedural complications, which include post-operative bleeding, need for blood transfusion, bladder perforation, obturator nerve stimulation, catheterization time, or need for hospitalization or bladder irrigation. The expected rate of composite complications is 10-15%. If one or more of the aforementioned complications occur, then the case will be recorded to have a complication.

Outcome Time Frame:

within 30 days of procedure

Safety Issue:


Principal Investigator

Daniel Canter, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University


United States: Institutional Review Board

Study ID:

PK Button and Bladder Tumors



Start Date:

December 2012

Completion Date:

December 2014

Related Keywords:

  • Bladder Cancer
  • bladder cancer
  • transurethral resection of bladder tumors
  • Urinary Bladder Neoplasms



Emory University Department of UrologyAtlanta, Georgia  30322