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Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

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Imidacloprid

The current treatment standard of care for patients who present de novo or with a recurrent bladder tumor is transurethral resection of the bladder tumor (TURBT) using monopolar electrocautery in the form a 90-degree loop electrode and has been used since its introduction in 1952. This intervention, accomplished endoscopically through the urethra, is both diagnostic and potentially therapeutic. An adequately performed TURBT will provide the pathologist with enough tissue to provide tumor grade and stage information.

Bipolar energy has been available for many years and has been readily adopted for the surgical treatment of benign prostatic enlargement and may provide advantages and solutions to the technical challenges of monopolar electrocautery. A further refinement on bipolar energy has been the recent introduction of the PlasmaKinetic (PK) Button Vaporization electrode which will be used in the intervention arm of this study. This electrode is already approved by the Food and Drug Administration (FDA) for this indication as well. The semi-spherical design of the electrode creates a plasma arc that glides over the tissue, transmitting energy to the cell layers adjacent to the arc which are then quickly vaporized.

Standard monopolar electrocautery loop in transurethral resection of bladder tumors (TURBT)

Monopolar electrocautery loop in Transurethral resection of bladder tumors

PlasmaKinetic (PK) Button Vaporization Electrode in transurethral resection of bladder tumors (TURBT)

PK Button Vaporization Electrode in transurethral resection of bladder tumors

Kenneth Ogan, MD

The purpose of this study is to compare the use of two types of equipment during transurethral resection of bladder tumors (TURBT). The two types of surgical devices are: the monopolar loop electrocautery and the PlasmaKinetic (PK) Button Vaporization Electrode. These two devices do the same task but differ in the way they create electric current when removing cancerous tissue. The investigators hope to examine and compare the uses of these two surgical devices to see if any advantages do exist or whether they actually are similar. The goal of the study is to prove similarity in outcomes between the two techniques and analyze the outcomes resulting from each case.

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 is to prove equivalence in outcomes between the two techniques.

PlasmaKinetic (PK) Button Vaporization Electrode for Treatment of Bladder Tumors

PK Button Vaporization Electrode for Treatment of Bladder Tumors

The number of procedural complications describes the total number of post-operative bleeding, need for blood transfusion, bladder perforation, obturator nerve stimulation, catheterization time, or need for hospitalization or bladder irrigation events that occur within thirty days of the procedure.

The average operative time was measured through study completion.

The average duration of the catheterization time was measured through study completion.

The number of participants who had disease recurrence within the four month follow up period.

Olympus

Emory University

Principal Investigator

Participants underwent a transurethral resection of the bladder tumor (TURBT) using monopolar loop electrocautery.

Monopolar Loop Electrocautery

Participants underwent a transurethral resection of a bladder tumor using a PK button vaporization electrode.

PK Button Vaporization Electrode

Participants completed a transurethral resection of the bladder tumor (TURBT) using monopolar loop electrocautery and all follow up procedures.

Participants completed a transurethral resection of a bladder tumor using a PK button vaporization electrode and all follow up procedures.

Total

Age, Continuous

Sex: Female, Male

White

Non-White

Unreported

Race/Ethnicity, Customized

United States

Region of Enrollment

Participants who completed all study procedures per protocol.

Dr. Kenneth Ogan

Number of Procedural Complications

Mean Operative Time

Participants who required catheterization after the operative procedure.

Mean Catheterization Time

Number of Participants With Disease Recurrence

Overall Study

Rare Diseases

Carcinoma

Carcinoma, Transitional Cell

Non-Muscle Invasive Bladder Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Transitional Cell Carcinoma

Central Nervous System Depressants

Antineoplastic Agents

Anti-Infective Agents

Anesthetics

Mitomycins

Mitomycin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Alkylating Agents

Enzyme Inhibitors

6 weekly intravesical instillations of UGN-102 (75 mg mitomycin) starting on Day 1 + TURBT for patients who have a NCR at the 3-month Visit (3 months after the start of treatment with UGN-102).

TURBT on Day 1 + repeat TURBT for patients who have a NCR at the 3-month Visit (3 months after the initial TURBT).

UGN-102 consists of mitomycin and sterile hydrogel (a proprietary thermally responsive gel) that is used to reconstitute mitomycin before instillation. The reverse thermal properties of UGN-102 allow for local administration of mitomycin as a liquid, with subsequent conversion to a semi-solid gel depot following instillation into the bladder.

UGN-102

The current standard of care for treatment of LG IR NMIBC is TURBT under general anesthesia.

TURBT

Sandip Prasad, MD

This is a global, randomized, controlled, open-label Phase 3 study designed to assess the long-term efficacy and safety of UGN-102 (mitomycin) for intravesical solution with or without (±) transurethral resection of bladder tumors (TURBT) versus TURBT alone for the treatment of patients with low grade intermediate risk non-muscle invasive bladder cancer (LG IR NMIBC).

Eligible patients will be randomized in a 1:1 ratio to UGN-102 ± TURBT or TURBT alone. Randomization will be stratified by the presence of a previous LG NMIBC episode within 1 year of the current diagnosis (yes or no). Starting at Day 1, patients randomized to the UGN-102 ± TURBT arm will receive 6 weekly intravesical instillations of UGN-102 and patients randomized to the TURBT alone arm will undergo TURBT.

Patients in both treatment arms will return to the clinic at approximately 3 months after the start of treatment to determine response to treatment. Patients confirmed to have a complete response (CR) will receive no further treatment and will enter the Follow-up Period of the study. Patients confirmed to have a non-complete response (NCR) will undergo TURBT of any remaining lesions and then enter the Follow-up Period of the study.

During the Follow-up Period, patients will return to the clinic every 3 months to determine durability of response. Patients will remain on study until completion of all follow-up visits or until disease recurrence, disease progression, or death is documented, whichever occurs first. Patients determined to have a protocol-defined recurrence or progression at any follow-up or unscheduled visit will be considered to have completed the study and released to the care of their treating physician.

Study enrollment was stopped early by the sponsor to pursue an alternative development strategy for UGN-102 in the treatment of bladder cancer. Patients who had consented at the time the trial terminated were permitted to continue, but follow-up was terminated once the last patient had been followed for 15 months after the start of treatment.

A Phase 3 Study of UGN-102 for Low Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer

A Randomized, Controlled, Open-Label Study of the Efficacy, Durability, and Safety of UGN-102 With or Without TURBT in Patients With Low Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer (LG IR NMIBC)

DFS is defined as the time from randomization until the earliest date of any of the following events: failure to be rendered free of local disease at the 3-month Visit (TURBT arm only), recurrence of LG disease after the 3-month Visit (ie, during the Follow-up Period), progression to HG disease, or death due to any cause.

TTR is defined as the time from randomization until the earliest date of any of the following events: failure to be rendered free of local disease at the 3-month Visit (TURBT arm only), recurrence of LG disease after the 3-month Visit (ie, during the Follow-up Period), or progression to HG disease.

CRR is defined as the percentage of patients who achieve CR at the 3-month Visit.

DOR is defined as the time from first documented CR until the earliest date of recurrence of LG disease, progression to HG disease, or death due to any cause. DOR applies only to patients who achieve CR at the 3-month Visit.

Observed CRR at scheduled disease assessment time points is defined as the percentage of patients who achieve CR at the 3-month Visit and maintain CR up to a particular follow-up visit.

Incidence of TURBT is defined as the percentage of patients requiring TURBT and the average number of TURBTs per patient in each treatment arm.

The European Organisation for Research and Treatment of Cancer (EORTC) 24-item quality of life questionnaire for patients with NMIBC (QLQ-NMIBC24) is a patient-reported instrument that assesses 11 domains (urinary symptoms, malaise, future worries, bloating and flatulence, intravesical treatment issues, sexual intimacy, risk of contaminating partner, male sexual problems, female sexual problems, sexual function, and sexual enjoyment).

Descriptive statistics will be used to summarize the scored scales for each of the domains and the change from baseline in the domain scores at each scheduled assessment time point.

The percentage of patients with each type of event will be summarized.

UroGen Pharma Ltd.

Anti-Arrhythmia Agents

Channel Blockers

Lidocaine

Patients scheduled for TUR for bladder tumor Intervention: uni-lateral obturator nerve block.

non-blocked obtorator side of each patient will be used as control

a uni-lateral obturator nerve block will be performed under ultrasound guidance- using 2% lidocaine for obtaining a short term block.

obturator nerve block

David Margel, MD, PhD

The aim of this study is to estimate the incidence rate of obturator nerve reflex and leg jerking during Transurethral Resections of Bladder Tumors (TURBTs), evaluate the efficacy of obturator nerve block in the prevention of inadvertent muscle spasm, and to identify predictors for both the jerking reflex and successful nerve block.

Study design: A single center single arm prospective study aiming to estimate the incidence rate of obturator nerve reflex and leg jerking during TURBTs, evaluate the efficacy of obturator nerve block (ONB) in the prevention of inadvertent muscle spasm, and identify predictors for both the jerking reflex and successful nerve block.

Study population: patients who are scheduled for TUR for bladder tumor, as standard care, who are willing and able to participate in the study

Intervention: a uni-lateral ONB (using Lidocaine 2%)

Study outline: Once in the operating room patients will be monitored by continuous electrocardiography, non-invasive arterial blood pressure measurement, and pulse oximetry in the usual manner. They will then undergo general or spinal anesthesia according to their preference and at the discretion of the treating anesthesiologist, without the use of muscle relaxants. As part of the study, a uni-lateral ONB will be performed under ultrasound guidance- using 2% lidocaine for obtaining a short term block, for the duration of the procedure itself. The non-blocked nerve will be used as control. The surgeon will be blinded as to the side in which the ONB has been performed. A catheter will be used to fill the bladder with saline to its full capacity. The inner wall of the bladder will then be stimulated to test for an obturator nerve reflex and leg jerking. Stimulation will be done using a trans-resectoscope and a single-twitch electrical current generated by a neuromuscular monitoring device, as previously described by Mihara et al. Four different bladder volumes will be tested. For each bladder volume, a reflex response on both sides will be documented and graded. The investigators will then proceed with a TUR in the usual manner.

Primary endpoints: frequency of obturator jerk reflex and efficacy of obturator nerve block

Prospective Clinical Trial - Obturator Reflex Predictors and Blockage

percentage of subjects for which the obtorator nerve block prevnted inadvertent obturator jerk

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PlasmaKinetic (PK) Button Vaporization Electrode for Treatment of Bladder Tumors	NCT01567462	Bladder Cancer	Monopolar elect... PK Button Vapor...	18 Years - 89 Years	Emory University
A Phase 3 Study of UGN-102 for Low Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer	NCT04688931	Bladder Cancer Urothelial Carc... Urothelial Carc...	UGN-102 TURBT	18 Years -	UroGen Pharma Ltd.
PlasmaKinetic (PK) Button Vaporization Electrode for Treatment of Bladder Tumors	NCT01567462	Bladder Cancer	Monopolar elect... PK Button Vapor...	18 Years - 89 Years	Emory University
Prospective Clinical Trial - Obturator Reflex Predictors and Blockage	NCT02228330	Malignant Neopl...	obturator nerve...	18 Years -	Rabin Medical Center

Spots Global Cancer Trial Database for transurethral resection of bladder tumors