Sanford Health
03/29/2021 | Press release | Distributed by Public on 03/29/2021 08:50
Sanford treats first patient in overactive bladder study
Sanford treats first patient in overactive bladder study
Contact:
Jon Berg
Sanford Health Media Relations
605-366-2432 / [email protected]
SIOUX FALLS, S.D., March 29, 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 eight or more times in a day.
Dr. Kevin Benson, a female pelvic medicine reconstructive surgery physician at Sanford Health in Sioux Falls, 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 Dr. Kevin Benson, a bladder health specialist at Sanford Health in Sioux Falls. '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 in Sioux Falls 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.
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 oasisoabstudy.com.
About Sanford Health
Sanford Health, one of the largest health systems in the United States, is dedicated to the integrated delivery of health care, genomic medicine, senior care and services, global clinics, research and affordable insurance. Headquartered in Sioux Falls, South Dakota, the organization includes 46 hospitals, 1,400 physicians and more than 200 Good Samaritan Society senior care locations in 26 states and 10 countries. Learn more about Sanford Health's transformative work to improve the human condition at sanfordhealth.org or Sanford Health News.