Clinical Trials

Clinical 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.

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.

An Open-Label Study of CC-10004 for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (HIC 2007-135) - STUDY CLOSED

This medication study is for men 18 and older with at least three months of symptoms of CP/CPPS who are refractory to other therapies, such as NSAIDS. This is a 16-week study with 10 study visits. CC-10004 is a TNF-a and phosphodiesterase type 4 inhibitor under development for use in the treatment of inflammatory conditions.

Observing Pelvic Organ Prolapse Symptoms and Treatment Outcomes (HIC 2008-242) - OPEN AND ENROLLING

The Prolapse Database is an ongoing study to prospectively observe the natural history of genital organ prolapse in women and determine outcomes of conservative and surgical prolapse treatment in terms of urinary, bowel, sexual function, and general quality of life.

Muscle Cell Mediated Therapy for Stress Urinary Incontinence: An Investigation of the Safety of 3 Different Doses of Autologous Muscle Derived Cells (HIC 2008-157) - OPEN, NOT ENROLLING

This is a clinical research study for urinary incontinence. Patients undergo a muscle biopsy of the leg. The harvested cells are grown in a laboratory and then injected into the patient's urethra. Patients must be female and older than 18 with symptoms of stress urinary incontinence.

A Clinical Trial of CC-10004 for the Treatment of Vulvodynia (HIC 2007-134) - STUDY CLOSED

This is a trial to study the safety and effectiveness of the study medication requiring a 16-week participation commitment with a total of 10 site visits. There will be a total of 20 female patients enrolled, ages 18-70. Participants must report at least three months of vulvar pain prior to enrollment and narcotic use must be stable for at least three months prior to enrollment. History of active TB within three years prior to the screening visit is exclusionary, as is a positive TB skin test (Mantoux test).

SuMit: Study of Urgent PC vs. Sham Effectiveness in Treatment of Overactive Bladder Symptoms (HIC 2008-182) - STUDY CLOSED

The goal of the study is to evaluate how percutaneous posterior tibial nerve stimulation (PTNS) compares to a sham therapy in patients with OAB symptoms. This study is for men and women 18 years or older with OAB symptoms of frequency (more than 10 times in 24 hours) or urgency or nocturia for greater than 3 months. The electrical stimulus is delivered via a needle, much like acupuncture, for 30 minutes on a weekly basis for 12 visits and is designed to re-train the bladder's response to signals from the nerves.

The Urinary Tumor Marker (Kidney Injury Molecule-1 or KIM-1) for the Detection of Renal Cell Carcinoma (HIC 2009-125) - OPEN AND ENROLLING

This is a study to identify a non-invasive urinary biomarker (KIM-1) that can be used to screen, diagnose and monitor renal cancers. The study will investigate how urine KIM-1 and a routine blood marker for renal failure (creatinine) can distinguish kidney tumors from non- tumor kidney injuries. There will be a control group who demonstrate normal serum creatinine and no radiological evidence of a renal tumor (25 patients) and a kidney cancer group (25 patients) that demonstrate a normal serum creatinine and radiological evidence of a renal mass. The control group should not have significant risk factors for kidney disease e.g. diabetes or HTN, and the kidney cancer group cannot have had previous therapy for renal cell carcinoma, or tumor metastasis.

Urine Biomarkers in IC/PBS Patients Before and After Treatment With InterStim® (HIC 2010-018) - OPEN AND ENROLLING

Urine will be collected from patients 18-69 years old with symptoms of urinary urgency and frequency and bladder pain for ³ 6 months. Patients must have had clinical symptoms of IC/PBS for at least 3 of the 6 months immediately before the first visit. Patients with pelvic mass, pelvic prolapse, urinary retention, and pelvic malignancies as revealed by physical examination will be excluded. Urine from patients will be included in the study if they had an average of ³ 10 voids/day and an average of ³1 nighttime void over 3 consecutive days on bladder diaries. All participants will complete a questionnaire (O'Leary Sant) at baseline and each follow up visit. IC/PBS patients included in the study will have an O'Leary-Sant composite score of 20 or higher at baseline.

InterStim® Rate Study (HIC 2009-166) - STUDY CLOSED

This four-week, four-visit study is to evaluate how the different rate settings of the InterStim® device affect the number of times per day a patient leaks urine. A total of 10 patients, already implanted with the InterStim® device, will be enrolled at Beaumont.

A Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study Evaluating the Efficacy and Safety of Tanezumab for the Treatment of Moderate to Severe Pain Associated with Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) (HIC 2009-224) - OPEN, NOT ENROLLING

The purpose of this 24-week study is to evaluate the safety, tolerability, pharmacokinetics and effectiveness of tanezumab, compared with placebo, in subjects with pain associated with IC/PBS, as well as other symptoms, such as having to urinate often, and feeling a strong urge to urinate which is difficult to ignore. Subjects must be 18 and older to participate.

A Randomized, Double-Blind Placebo-Controlled Study to Explore the Efficacy, Safety and Tolerability of JNJ 421060443 in Subjects With Interstitial Cystitis/Painful Bladder Syndrome (HIC 2010-052) - STUDY CLOSED

The purpose of this study is to evaluate the potential side effects and pain-relieving effects of JNJ-42160443 for the relief of bladder pain related to the diagnosis of interstitial cystitis/painful bladder syndrome, when compared to placebo. A total of 4 men and women between the ages of 18-80 will participate at Beaumont.

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study Of The Efficacy And Safety Of Intraprostatic Administration Of Botox 200 U (Botulinum Toxin Type A) Purified Neurotoxin Complex To Treat Lower Urinary Tract Symptoms Due To Benign Prostatic Hyperplasia (HIC 2010-151) - OPEN AND ENROLLING

This study will look at the efficacy and safety of Botox versus placebo when injected into the prostate. To qualify for the study, participants must be showing lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). This study, which can last up to six months, requires an initial screening visit in the Urology Research office, two phone visits with the study coordinator, seven visits to the office over the course of the study at different intervals, and one visit once study treatment is completed.