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:

Tracy Daye-Groves at tmgroves@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

 

PROSTATE CANCER

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 

 

Development of Protein Biomarkers from Urine of Prostate Cancer Patients 

Principal Investigator: Dr. Christopher Warlick

Synopsis: The purpose of this study is to identify a panel of protein biomarkers excreted in the urine that distinguishes low-risk prostate cancer (Gleason score 6 or lower) from aggressive subtypes (Gleason score 7 or higher) in newly diagnosed prostate cancer patients, to build a model based on these biomarkers that predicts the risk of aggressive subtype, and to estimate the predictive ability of the model.

Inclusion Criteria:
  • Adult (18+) men with newly-diagnosed biopsy-confirmed prostate acinar adenocarcinoma without evidence of metastatic disease. 

Kidney Stones

pNORC

Principal Investigator: Dr. Michael Borofsky and Dr. Deepak Agarwal

Synopsis: To prospectively determine if the removal of non-obstructing renal calculi can reduce or eliminate participant's pain and/or improve their quality of life. 

Inclusion Criteria:
  • Patients with renal colic and non-obstructing renal calculi. No stone greater than 10 mm in longest diameter
  • All other causes of pain have been eliminated
  • Patients older than 18 years old
  • Moderate to severe pain (>=5 on BPI pain scale: pain at its worst in the last 24hrs)

MALE INFERTILITY

Effect of Varicocelectomy on Capacitation score

Principal Investigator: Dr. Joshua Bodie

Synopsis: To assess if varicocelectomy improves capacitation score index in men with male factor infertility.

Inclusion Criteria: 
  • Men with male factor infertility as diagnsed by 2 pre-operative comprehensive semen analysis who elect to undergo elective microscopic varicocelectomy for treatment of clinically significant varicocele. 

 

Sacral Nerve Neuromodulation Therapy

Clinical Study of Neuspera's Implantable Sacral Nerve Stimulation (SNS) System in Patients with Symptoms of Urinary Urgency Incontinence (UUI)

Principal Investigator: Dr. Nissrine Nakib

 Synopsis:  

Prospective, multi-center, single-arm, seamless phase-pivotal study conducted in participants diagnosed with UUI who have failed or could not tolerate more conservative treatment. The trial will be conducted in two phases.

Objective of Phase I: To assess the utilization of the system during the Sacral Nerve Stimulation (SNS) trial period and to help inform the length of hours of daily stimulation to be used in Phase II of the trial.

Objective of Phase II: To assess the safety and efficacy of the Neuspera SNS System at 6-months for the primary efficacy endpoint and at 12 months for secondary safety and efficacy endpoints.

 Inclusion Criteria:

  1. Has a Body Mass Index (BMI) between 18 and 40.
  2. Has a diagnosis of UUI for greater than or equal to 6 months prior to the screening baseline visit date.
  3. Has failed or was not a candidate for more conservative treatment (e.g. pelvic floor training, biofeedback, behavioral modification).
  4. Has failed or could not tolerate (stopped taking medication due to lack of efficacy or intolerable side effects) at least one (1) antimuscarinic or β3 adrenoceptor agonist medication.
  5. Has a diagnosis of UUI with at least 4 UUI episodes on a 72-hour diary, and minimum of one (1) UUI episode per 24-hour period.

UP and COMING STUDIES

 Overactive Bladder: Composur, A Patient-centric, Phase IV, Open-label, Prospective, Real World US Study to Evaluate Vibegron on Patient Treatment Satisfaction, Quality of Life, and Healthcare Resource Utilization in Overactive Bladder

PI: Dr. Nissrine Nakib 

Summary: This study will evaluate the treatment satisfaction, discontinuation, reasons for discontinuation, quality of life, healthcare resource utilization, and safety with Vibegron for the treatment of OAB in the context of real-world clinical practice.

 

BPH: Butterfly Pivotal Study

PI: Dr. Michael Borofsky and Dr. Deepak Agarwal

Summary: A prospective, multicenter, blind randomized (2:1) controlled study comparing the International Prostate Symptom Score (IPSS) of the Active arm to the IPSS of the control arm at the 3 months follow-up and active arm IPSS score change from time zero to 12 months. Patients in the active arm undergo Butterfly device treatment. Patients in the control arm undergo a sham rigid cystoscopy procedure