Research

urology research

Clinical Trials

Clinical trials strive to find solutions to some of life’s most complex conditions, diseases, and disorders. They are modern medicine’s answer to the questions “why?” and “how?”

Through clinical trials, we find out whether a new treatment works and is safe. For many, they provide hope and promise for an improved quality of life. They are carefully designed research studies that answer specific questions about the effectiveness of preventive techniques, medications, therapies and treatments and surgical techniques.

Clinical trials strive to find solutions to some of life’s most complex conditions, diseases, and disorders. They are modern medicine’s answer to the questions “why?” and “how?”

Through clinical trials, we find out whether a new treatment works and is safe. For many, they provide hope and promise for an improved quality of life. They are carefully designed research studies that answer specific questions about the effectiveness of preventive techniques, medications, therapies and treatments and surgical techniques.

About the Center for Clinical Trials

The Department of Urology’s Center for Clinical Trials is a clinical research center that helps facilitate innovative new products and medications for the research community and patients by conducting Phase Ⅰ - Ⅳ clinical trials. Phase Ⅰ is the safety and tolerability of treatment in a small number of individuals. Phase Ⅱ is the efficacy of treatment that is proven to be safe for humans. Phase Ⅲ is the comparison of treatment to current FDA approved treatments in a larger group number of participants. Phase Ⅳ is studying the long term data of the treatment after being on the market.

Participation in a clinical trial does not substitute for regular medical care. Discuss participation in clinical trials with your physician. For more information about current clinical trials, or the clinical trial process at the University of Minnesota, please contact either:

Siobhan O’Toole at otool098@umn.edu or 612-625-3319 

Maressa Twedt at twedt050@umn.edu or 612-626-6661

Current Clinical Trials

Click the tabs below to view details on clinical trials within the Department of Urology. Contact the researcher listed within each trial for more information.

BLADDER CANCER

Use of a multiplexed molecular biomarker test Cxbladder, in Real World decision making to provide Clinical Utility Using a Randomized Design 

Principal Investigator: Dr. Christopher Warlick

Synopsis: The objective of this study is to evaluate the clinical utility associated with the integration of Cxbladder into the evaluation of subjects presenting with hematuria for evaluation of urothelial carcinoma (UC) without compromising detection of UC. 

Inclusion Criteria:
  • Patient is undergoing investigation of recent confirmed hematuria (by either flexible or rigid cystoscopy/TURBT), including hematuria subjects referred due to suspicious/positive imaging, in order to determine the presence of urothelial carcinoma.

A Phase 1/2 Study of EG-70 as an Intravesical Administration to Patients with BCG-Unresponsive NMIBC

Principal Investigator: Dr. Joseph Zabell

Synopsis: Study EG-70-101 is a Phase 1/2, open-label, multicenter, safety and dose-finding study to determine the safety, tolerability, and efficacy of EG-70 in adult patients with NMIBC who have failed BCG therapy and are recommended for radical cystectomy.  The study consists of two parts, a Dose-Escalation Phase (Phase 1), followed by a Phase 2 study at the RP2D and a pivotal Efficacy Expansion of the Phase 2 study.

Inclusion Criteia:
  • Subjects with BCG unresponsive non-muscle invasive bladder cancer (NMIBC) and are ineligible for, or have elected to not undergo cystectomy.

 

 

URINARY INCONTINENCE

Artificial Urinary Sphincter Clinical Outcomes

Principal Investigator: Dr. Sean Elliott

Synopsis: The AMS 800 Artificial Urinary Sphincter is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The purpose of this study is to evaluate the AMS 800 Artificial Urinary Sphincter™ (AUS) in men with primary stress urinary incontinence as measured by pad weight tests.

Inclusion Criteria:
  • Has undergone either a radical prostatectomy, transurethral resection of the prostate or other invasive prostate surgery
  • Demonstrates primary stress urinary incontinence Positive screening 24-hour pad weight test (≥100 grams)
  • Experiences at least 3 incontinence episodes per day during baseline diary
  • Negative urine culture
  • Willing and able to undergo surgical implantation of the AUS device

PROSTATECTOMY

Ex-Vivo Targeted Treament of Extirpated Prostate Tissue Targeted-EX Study

Principal Investigator: Dr. Christopher Warlick

Synopsis: Targeted-EX is used to perform bench testing of the needle's biocapacitance tip on the extirpated prostate tissue to support and evaluate functionality, product development, and product improvemens of the Francis Medical Vapor Ablation System prior to use in an in-vivo clinical trial.

Inclusion Criteria:
  • Subjects with the ability to understand and consent to releasing their extirpated prostate for use in the study.
  • Prostates removed via a radical prostatectomy 

UP and COMING STUDIES

Selective Bladder Denervation Using Engery for the Treatment of UUI (Transform UUI)

Principal Investigator: Dr. Nissrine Nakib

Synopsis: Transform UUI is a pivotal study to collect data on the safety and effectiveness of hte Hologic trigone radiofrequency ablation device to reduce urinary incontinence.