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.

QUILT Study – bladder cancer study

The purpose of this study is to assess the antitumor activity of intravesical BCG in combination with ALT-803 immunotherapy protein complex in patients with BCG unresponsive high-grade NMIBC as determined by the disease response rating using cystoscopy, bladder biopsy and urine cytology.

Eligibility Criteria
Major inclusion criteria
  • Male or female patients 18 years of age or older.
  • Histologic confirmation of NMIBC of the transitional cell carcinoma high-grade subtype.
  • BCG unresponsive disease as defined as persistent high grade disease or recurrence within 6 months of receiving at least 2 courses of BCG (1 induction course and 1 maintenance course).
Major exclusion criteria
  • Recurrence > 6 months after last BCG instillation.
  • Evidence of muscle-invasion or regional and/or distant metastatic bladder cancer.
  • Symptomatic CHF, severe/unstable angina pectoris, or myocardial infarction within 6 months prior to study entry.

PREVAIL Study – Non-Interventional Study for Patients with Locally Advanced/Unresectable or Metastatic Bladder Cancer

The purpose of this study is to assess the prevalence of PD-L1 expression in the first-line setting of locally advanced/unresectale or metastatic urothelial carcinoma.

Eligibility Criteria
Major inclusion criteria
  • Patients age ≥ 18 years or older.
  • Patients with histologically confirmed diagnosis of UC and confirmed advanced UC prior to or during 1L therapy.
  • Patients with available tumor tissue sample that was collected as part of standard of care and time prior to 1L therapy.
Major exclusion criteria
  • Patients with history of non-urothelial active malignancy that completed therapy within 2 years from study enrollment.
  • Patients concurrently enrolled in other clinical trials that prohibit their participation in a non-interventional study.

Overactive bladder

DAWN Study – Nocturia due to Nocturnal Polyuria

The purpose of this study is to establish the dose-response of study drug in an effort to reduce the number of nocturnal voids during 12 weeks of treatment in patients with Nocturia due to nocturnal polyuria.

Eligibility Criteria
Major inclusion criteria
  • Medical history of, or subject reported Nocturia symptoms during the last 6 month prior to visit 1.
  • ≥2 nocturnal voids (and average over 3 days) as documented in the 3-day e-Diary prior to visit 2.
  • Nocturnal polyuria, defined as NPi >33%, a ration of NUV in excess of 33% of total daily (24 hour) urine volume as documented in 3-day e-Diary.
Major exclusion criteria
  • Bladder outlet obstruction (BOO) or urine flow < 5 mL/s as confirmed by uroflow.
  • Urinary incontinence defined as an average of >1 episode/day in the 3-day e-Diary prior to visit 2.
  • History of cancer with the last date of disease activity/presence of malignancy within the last 12 months prior to visit 1.

COURAGE Study – Men with Overactive Bladder (OAB) with Benign Prostatic Hyperplasia (BPH)

The purpose of this study is to evaluate the safety, efficacy and tolerability of study drug in mend with symptoms of OAB currently being treated for benign prostatic hyperplasia (BPH).

Eligibility Criteria
Major inclusion criteria
  • Male subjects 45 years of age and above.
  • Subjects should have been on and agree to continue stable dose of BPH treatment.
  • IPSS score of ≥ 8 at Screening.
Major exclusion criteria
  • Subject has history of prostate surgery, including minimally invasive transurethral or transrectal procedures within 6 months prior to screening.
  • Subject is taking or using any medications to treat ED and is not using them on a regular schedule.
  • Has a maximum urinary flow < 5.0 mL/second.

APOLLO Study – Intravesical BOTOX Instillation in Patients with Overactive Bladder (OAB) and Urgency Urinary Incontinence

The purpose of this study is to evaluate the safety and efficacy of BOTOX intravesical instillation at improving the symptoms of OAB as measured by the reduction in daily urinary incontinence episodes.

Eligibility Criteria
Major inclusion criteria
  • Male or Female subject aged 18 to 75 years.
  • Has symptoms of OAB with urgency urinary incontinence for at least 6 months immediately prior to screening.
  • Experiences ≥ 3 episodes of urge urinary incontinence per day and an average of ≥ 8 micturitions per day.
Major exclusion criteria
  • Has symptoms of OAB due to any known neurological condition.
  • Has predominance of stress urinary incontinence.
  • Has a history or current diagnosis of bladder cancer or other urothelial malignancy.

Urethral strictures

ROBUST III study – treatment of urethral strictures in men

The purpose of this study is to assess the safety and effectiveness for the Urotronic OptilumeTM Stricture Drug-Coated Balloon (DCB) for the treatment of anterior urethral strictures in male patients.

Eligibility Criteria
Major inclusion criteria
  • Men age >18 years or older.
  • Single, tandem or diffuse anterior urethral strictures < 3cm total length as measured by retrograde urethrogram.
  • P2 to 5 prior dilation treatments of the same stricture (including DVIU).
Major exclusion criteria
  • Previous urethroplasty within the anterior urethra.
  • Stricture dilated or incised within the last 3 months.
  • BPH, bladder neck contracture, SUI, new diagnosis of OAB (w/in last 6 months).

Low testosterone

TRAVERSE Study – men with low-t with increased cardiovascular (CV) risk

The purpose of this study is to evaluate cardiovascular (CV) risk in middle-ages and older hypogonadal men treated with testosterone replacement therapy (TRT).

Eligibility Criteria
Major inclusion criteria
  • Men age between 45 and 80 years (inclusive).
  • Meet study definition of clinical hypogonadism and who are naïve to testosterone replacement OR has not been treated with TRT within last 6 month.
  • Has pre-existing CV disease.
Major exclusion criteria
  • Congenital or acquired hypogonadism for whom long-term therapy with placebo would not be medically appropriate.
  • History of prostate or breast cancer or prostate nodule or induration at screening DRE.
  • PSA >3.0 ng/mL and IPSS >19.

Clinical Trials

For more information about current clinical trials or the clinical trial process at Urology Associates, contact our clinical research manager, Lenden Neeper, MS, CCRP:

303-733-8848

[email protected]