March 29, 2021

This paid piece is sponsored by Sanford Health.

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 an abnormal or sudden need to pass urine, accidental leakage and frequent urination of eight or more times in a day.

Dr. Kevin Benson, a female pelvic medicine reconstructive surgery physician at Sanford Health, is a clinical investigator in the OASIS clinical trial of the RENOVA iStim™ system and has now treated the first patient in the region 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,” said Benson, a bladder health specialist.

“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.”

Sanford Health is one of only a handful of sites participating in the clinical trial.

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.

The RENOVA iStim system, developed by BlueWind Medical, 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.

The OverActive Bladder Stimulation System Study, or OASIS, is a prospective, interventional, multicenter study that will evaluate the safety and efficacy of RENOVA to improve urinary urgency incontinence episodes. The OASIS study will enroll approximately 200 subjects at 20 to 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, age 18 to 80, with a six-month or more diagnosis of urinary urgency incontinence. To determine if you might qualify, visit oasisoabstudy.com.