Urology Clinical Trials

urology clinical trials at BeaumontClinical trials are studies, managed by government agencies, educational institutions, private not-for-profit organizations, or commercial businesses, to develop, produce and evaluate the effectiveness of new treatments and therapies for diseases.

Beaumont’s urology department is focused on urologic disease research to develop, produce and evaluate the effectiveness of new, innovative approaches to treatment that may improve patient outcomes and quality of life. Areas of research interest and expertise cover a wide range of urologic diseases.

Individuals who participate in research studies are given the opportunity to benefit from treatments that are not currently available to the general public, but have shown promise in previous research.

What are the risks and benefits of participating in a clinical trial?

Individuals who participate in research studies are given the opportunity to benefit from treatments that are not currently available to the general public, but have shown promise in previous research.

Risks from participating in a clinical trial vary depending on the study. It is important to understand that not all new treatments produce the desired effect.

A Double-Blind, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR with Placebo in Female Subjects with Stress Urinary Incontinence

In this study for adult women with stress incontinence (accidental leakage of urine when coughing, sneezing, exercising) a small sample of muscle is taken from the thigh, processed, and the cells (AMDC) are re-injected into the tissue of the urethra (the tube that allows urine to pass out of the body). It is believed that these cells can become part of the tissue where they have been injected. The study consists of two parts: a randomized, blinded phase where subjects are randomly assigned to receive cells or placebo (fluid with no active ingredient). Women that are randomly chosen to be in the placebo group may choose to receive treatment with AMDC after 12 months of follow up. Study participation will last up to two years.

Sponsor - Cook Myosite

Muscle Cell Mediated Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery: An Investigation of Cook MyoSite Autologous Muscle Derived Cells (AMDC)

Men who have stress incontinence (accidental leakage of urine when coughing, sneezing, exercising) following prostate surgery are eligible for this study. A small sample of muscle is taken from the thigh, processed, and the cells are re-injected into the tissue of the urethra (the tube that allows urine to pass out of the body). It is believed that these cells can become part of the tissue where they have been injected. Participants will be followed for two years.

Sponsor – Cook Myosite

A Multicenter, Double-Blind, Randomized, Dose-Ranging, Placebo Controlled Trial Comparing the Safety, Tolerability and Efficacy of LP-08 with Placebo in Subjects with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

LP-08 is a substance called liposomes. Liposomes are tiny vesicles (bubbles) composed of a mixture of fats that are already present in the human body and our food supply. Placing liposomes in the bladder may form a protective film on the bladder surface in patients with IC/BPS and provide a safe, effective, and simple treatment option for healing and improving symptoms. In this study, subjects are randomly assigned to receive liposomes or placebo (fluid with no active ingredient). This study is for men and women with IC/BPS. Those that are randomly chosen to initially be in the placebo group will have the option of receiving treatment with LP-08 at the 8 week follow-up visit. Study participation will last up to 7 months.

Sponsor – Lipella Pharmaceuticals

Botox® in the Treatment of Urinary Incontinence Due to Overactive Bladder in Patients 12-17 Years of Age

This study will evaluate the safety and efficacy of onabotulinumtoxinA for the treatment of urinary leakage due to overactive bladder (urinary urgency and frequency, with or without incontinence) in pediatric patients between 12 to 17 years old. Participation in the study is approximately 2 years, with up to 12 clinic visits and 7 telephone visits. The study medication is injected into the bladder during cystoscopy to relax it and prevent bladder spasms that can cause accidental leakage of urine.

Sponsor-Actavas

Biowave Overactive Bladder Trial (OAB)

This study will assess the response to the micro-needle patch electrode stimulation of the posterior tibial nerve using the Biowave device in women 18 years of age and older with overactive bladder symptoms. The investigator hypothesizes that after at least 6 weekly treatments there will be modest improvements in overactive bladder symptoms trending toward more improvement.

Sponsor – Physician Initiated

For more information, visit http://clinicaltrials.gov/ct2/show/NCT01848366

BOTOX® in the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Patients 8 to 17 Years of Age (#120)

This study will evaluate the safety and efficacy of onabotulinumtoxinA for the treatment of urinary incontinence due to neurogenic detrusor (bladder muscle) overactivity in pediatric patients from the age of 8 to 17 years.  This study is for children who regularly using clean intermittent catheterization to empty their bladders.  The study medication is injected into the bladder during cystoscopy.

Sponsor – Allergan

For more information, visit http://clinicaltrials.gov/show/NCT01852045

Coming soon (Not HIC approved as of December 4, 2014)

A double-blind, randomized study to compare Onobotulinumtoxin A vs. Kenalog for intravaginal trigger point injections in the treatment of chronic pelvic pain

The goal of this study is to compare the effectiveness of two different medications used for pelvic floor muscle trigger point injections (injections into extremely painful areas of a muscle) to treat chronic pelvic pain in women. We are comparing OnabotulinumtoxinA (BOTOX®) (a drug prepared from the bacterial toxin botulin which temporarily paralyzes muscles) to Kenalog (a synthetic corticosteroid used as an anti-inflammatory agent). Participants will be followed for approximately 6 months.

Sponsor – Philanthropy 

A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects with Overactive Bladder (OAB)

Mirabegron is an FDA approved medication for overactive bladder (urinary urgency and frequency, with or without urinary incontinence). The purpose of the study is to evaluate the safety and effectiveness of mirabegron (MYRBETRIQ) specifically in older adults 65 years of age or greater. This study will compare mirabegron to placebo, and study participants will be followed for approximately 6 months.

Sponsor- Astellas