First Patient In Maryland Treated In The OASIS Clinical Trial - Chesapeake Urology

Chesapeake Urology Treats First Patient in Maryland in the OASIS Clinical Trial for Overactive Bladder

The Center Is Recruiting Additional Women to Participate in Study of RENOVA iStim System, a Minimally Invasive Home-Based Treatment for OAB

Owings Mills, MD (January 27, 2021) — Overactive bladder or OAB, affects millions of women of all ages, and can negatively impact nearly every aspect of daily life—from work performance to family life, to social interactions. OAB symptoms can vary, but typically include abnormal or a sudden need to pass urine, accidental leakage, and frequent urination of 8 or more times in a day.

There are approximately 40 million adults in the U.S. who experience OAB. Current treatment options, such as sacral nerve stimulation devices, require extensive surgery, general anesthesia, and battery replacement. Other treatments require weekly visits to the doctor’s office. RENOVA is a tiny, battery-less, and lead-less neurostimulation implant that provides a patient-centric, home-based alternative therapy option for women with OAB.

Dr. Laura Giusto at Chesapeake Urology is a clinical investigator in the OASIS Clinical trial of the RENOVA iStim™ system and has now treated the first patient in Maryland, in this international study. The RENOVA iStim system is an investigational device designed to reduce urinary urge leakage and improve OAB symptoms.

“Overactive bladder can be debilitating and stressful. Many patients tell me that they will limit how far or frequently they venture from home—and that the first thing they do when arriving at a restaurant or a store, is to locate the restroom. While current treatments work for some OAB sufferers, there is a need for more effective, discreet, and minimally invasive treatment options for women who do not benefit from medications and don’t want more invasive surgery,” said Dr. Giusto, the OASIS Study site Principal Investigator. “I’m pleased to say that our first implant procedure went smoothly. The RENOVA iStim implant was placed during an outpatient procedure and treatment will now be done at the patient’s home. Especially now during a pandemic, having an option that does not require frequent doctor visits, and allows women to manage their treatment at home on their schedule, may be of interest to many women with OAB. I am excited to participate in the OASIS clinical trial and look forward to enrolling several women who meet the trial qualifications to advance this important research.”

About the RENOVA iStim System:

The RENOVA iStim system, developed by BlueWind Medical, is an investigational device designed to reduce urinary urge leakage and improve OAB symptoms. The RENOVA iStim uses a miniature implant that is placed during an outpatient procedure under local anesthesia. The implant is placed just above the ankle, near the tibial nerve. The implant stimulates the tibial nerve that communicates with nerves in the low back that control bladder function. A comfortable, wearable cuff powers the implant and is worn for just 30 to 120 minutes per day.

About the OASIS Clinical Trial:

The OverActive Bladder Stimulation System Study (OASIS), a prospective, interventional, multi-center study, will evaluate the safety and efficacy of RENOVA to improve urinary urgency incontinence (UUI) episodes. The OASIS study will enroll approximately 200 subjects at 20-25 study sites in Europe and the U.S. Results of this pivotal clinical trial will be the basis of a submission to the U. S. Food and Drug Administration. The study is recruiting women, ages 18 to 80, with a six-month or more diagnosis of urinary urgency incontinence. To determine if you might qualify, visit: https://oasisoabstudy.com/ or contact the study coordinator, Rayna Bennett Campbell, 443-231-1203, rbennett@chesuro.com

About the CENTER:

About Chesapeake Urology:

Chesapeake Urology, an affiliate of United Urology Group, is a fully-integrated urology practice providing a comprehensive array of urologic services to its patients, including clinical trials. The Company operates 25 medical offices and 18 AAAHC-certified ambulatory surgery centers in Anne Arundel, Baltimore, Harford, Howard, Carroll, Montgomery, Prince George’s, Wicomico, Worcester counties in Maryland, Baltimore City, and Sussex County, Delaware, and has a staff of more than 900 including more than 85 physicians. Chesapeake Urology has been named one of the top places to work in healthcare nationally by Modern Healthcare magazine and Becker’s ASC Review, and locally by the Baltimore Sun, Baltimore magazine, and the Baltimore Business Journal. For additional information, please visit ChesapeakeUrology.com.

CAUTION—Investigational device. Limited by Federal (or the United States) law to investigational use.

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