Clinical Trials

Clinical trials are carefully designed research studies that answer specific questions about the safety and effectiveness of preventive techniques, medications, treatments, therapies or surgical techniques. Participation in a clinical trial is strictly voluntary.

Many studies that are developed and available are similar to treatments often referred to as the “gold standard.” Advancements in medicine may lead to improved outcomes through improved results, less discomfort, less time involved in treatment, lower cost, and/or improved safety. At Urology Associates, we are very selective about studies that we choose to offer to our patients. Please read further to see what is currently offered and contact our office with any questions.

Urology Associates is enrolling patients for clinical trials for benign prostatic hyperplasia (BPH), urologic cancersstress incontinence, among others, in order to help our patients live longer, healthier lives.

Am I eligible?

Many studies have strict enrollment criteria. The list of inclusion and exclusion criteria are different for each study. Our office can easily assess whether a patient is eligible for a particular study.

Deciding whether or not to participate in a urology clinical trial is a very important choice that should be carefully considered and thoroughly discussed between a patient and his or her doctor.

For more information about whether a patient is eligible for our studies, please visit clinicaltrials.gov or Contact Us Online

Bladder cancer

CONQUER – bladder cancer study

The purpose of this study is to evaluate the Time to Recurrence in patients with low- to intermediate-risk non-muscle invasive bladder cancer (NMIBC) who receive either 8 mg Qapzola or placebo post transurethral resection of bladder tumor (TURBT).


Eligibility Criteria
Major inclusion criteria
  • Patient has diagnosis of low to intermediate risk NMIBC
  • Patient is at least 18 years of age and <90 years of age
Major exclusion criteria
  • Patient has high risk NMIBC or bladder cancer that is muscle invasive or positive for metastasis
  • Patient has received any previous intravesical therapy for bladder cancer – chemotherapy, immunotherapy (NO BCG!)
  • Patient has any unstable or uncontrolled medical condition that would make it unsafe to undergo a TURBT

VISTA – bladder cancer study

The purpose of this bladder cancer study is to assess the safety and tolerability of Vicinium monotherapy (administered via intravesical instillation) for the treatment of non-muscle invasive CIS and/or high-grade papillary disease of the bladder in subjects who failed previous treatment with Bacillus Calmette-Guerin (BCG).


Eligibility Criteria
Major inclusion criteria
  • Male or non-pregnant, non-lactating female, age > 18 years
  • Histologically confirmed high-grade non-muscle invasive bladder cancer – CIS, Ta or T1 papillary disease or some combination thereof following adequate BCG treatment and is unresponsive (refractory or relapsing)
Major exclusion criteria
  • Evidence of urethral or upper tract transitional cell carcinoma (TCC) by biopsy or upper tract radiological imaging
  • Subjects with hydronephrosis, except for those subjects in which this is longstanding (predates the diagnosis of CIS, Ta or T1 by more than 2 years) without evidence of tumor
  • History of other primary malignancy (excluding squamous or basal cell skin cancers)

Xpert Study – bladder cancer assay study

The purpose of this study is to establish the clinical performance characteristics of the Xpert Bladder Cancer Monitor on the GeneXpert Instrument Systems to detect the recurrence of bladder cancer in patients previously diagnosed with bladder cancer.
Eligibility Criteria
Major inclusion criteria
  • Male or female age 40 years or more
  • Disease positive within 12 months
  • Must provide at least 60mL of voided urine prior to SOC cystoscopy
Major exclusion criteria
  • Patients who had an excision procedure within six weeks are ineligible

Urological Patients (Non-Bladder Cancer)

XPERT 171 – non-bladder cancer study

The purpose of this study is to establish the clinical specificity of Xpert Bladder Cancer Monitor in 1) urology patients that are nonsymptomatic for bladder cancer with no prior history or clinical evidence of bladder cancer and 2) in healthy volunteers.


Eligibility Criteria
Major inclusion criteria
  • Subject is ≥50 years of age
  • Subject is referred for a urology consultation OR subject is a healthy volunteer
  • Subject has agreed to provide at least 20 mL of voided urine for study purposes
Major exclusion criteria
  • Subject has been previously diagnosed with bladder cancer, has previously presented with clinical evidence of bladder cancer, or presents with suspicion of bladder cancer at the enrollment visit
  • Healthy Volunteers Only: Subject diagnosed with a genitourinary disease or condition within the prior twelve months (365 days) of the enrollment visit
  • Patient has any unstable or uncontrolled medical condition that would make it unsafe to undergo a TURBT

Overactive bladder

PLUS study – male overactive bladder (OAB) study

The primary objective is to study the efficacy of mirabegron versus placebo in men with OAB symptoms while taking tamsulosin hydrochloride for LUTS due to BPH.
Eligibility Criteria
Major inclusion criteria
  • Men age ≥40 years with history of OAB while taking tamsulosin 0.4mg daily for at least 2 months
  • PSA <4 ng/ml OR PSA> 4 but <10 ng/ml with negative prostate biopsy within past year
  • Frequency of ≥ 8 micturitions per day with urgency for ≥ 3 months prior to screening
Major exclusion criteria
  • Neurogenic bladder
  • Previous or planned prostate surgery, electrostimulation (PTNS), or Botox within 12 months of screening
  • Clinically significant bladder outlet obstruction or significant stress incontinence
 

Bioness StimRouter study – overactive bladder (OAB)

The purpose of this study is to assess the safety and efficacy of the StimRouter stimulation therapy in improving overactive bladder (OAB) symptoms when targeting the posterior tibial nerve.
Eligibility Criteria
Major inclusion criteria
  • Male or female age 22 years or more
  • Average urinary frequency of ≥10 daily voids with urgency
  • Able to toilet self and maintain good personal hygiene
  • Patient must have a body mass index (BMI) of less than or equal to 30
  • Willing to discontinue any tricyclic antidepressant
Major exclusion criteria
  • Treated with Botox or surgery in past 12 months
  • Current or prior use of PTNS, SNS, pelvic floor muscle stimulation or biofeedback
 

Detrusor overactivity

Gelnique – pediatric detrusor overactivity study

The purpose of this study is to evaluate the efficacy of daily treatment with oxybutynin chloride gel in pediatric patients with detrusor overactivity associated with a neurological condition who are using clean intermittent catheterization (CIC).
Eligibility Criteria
Major inclusion criteria
  • Patient age 3 ­– 16 years
  • Diagnosed with detrusor overactivity associated with a neurological condition
  • Must be using CIC
Major exclusion criteria
  • Patient-reported CIC use higher than 6 times within 24 hours
  • Urinary tract anatomical abnormalities
  • Have had surgical bladder augmentation within 1 year of study screening

Prostate cancer

TRUMPET study – Astellas metastatic castration-resistant prostate cancer (CRPC) registry

Collection of data from patients with metastatic castration-resistant prostate cancer (mCRPC) who are receiving their first approved, active course of anti-cancer treatment.

Eligibility Criteria
Major inclusion criteria
  • Male patient age > 18 years
  • Confirmed diagnosis of CRPC, as defined by a minimum of two rising PSA levels measured at least 7 days apart, and serum testosterone level <73 nmol/L (50 ng/dL), or with new evidence of metastatic disease by investigating physician
  • Initiating first active course of anti-cancer treatment for M0 CRPC or for M1 CRPC (regardless of prior M0 CRPC treatment) such as anti-androgens, androgen synthesis inhibitors, chemotherapy, immunotherapy or radionuclide therapy. Patients may be enrolled within 45 days from the time of treatment initiation
Major exclusion criteria
  • Patient is currently enrolled in any interventional clinic trial with a non-approved investigational agent for the primary disease of CRPC at study entry
  • Patient is receiving concomitant treatment for other cancer (excluding basal cell carcinoma and treatment for hormone sensitive prostate cancer) within 6 months prior to enrollment

Female Stress Urinary Incontinence (SUI)

ASTRID study – female urinary icontinence (SUI) study

The purpose of this study is to assess the safety and tolerability of study drug GTx-024 (Enobosarm) in post-menopausal women with stress urinary incontinence (SUI).

Eligibility Criteria
Major inclusion criteria
  • Women age 40-80 years old
  • SUI symptoms for at least 6 month duration
  • A minimum of 1 and no more than 15 SUI episodes per day AND no fewer than 9 SUI episodes over 3 days
Major exclusion criteria
  • Pelvic floor therapy within 30 days prior to screening
  • History of urethral sling, anterior prolapse repair, urethral bulking agents and/or other SUI procedure or surgery
  • Subject is morbidly obese

Clinical Trials

For more information about current clinical trials or the clinical trial process at Urology Associates, contact Lenden Neeper:

303-733-8848

[email protected]