Multi-center Study Published in Urology Confirms Efficacy and Safety of Avation Medical’s Noninvasive Vivally® System for OAB

Avation Medical, Inc., an innovative neuromodulation and digital health company with a mission to make wearable peripheral neuromodulation accessible to patients across a variety of clinical conditions, today announced the publication of safety and efficacy results from a multi-center study, “FREEOAB”, for its novel Vivally System in Urology, a leading, peer–reviewed journal for urologists. “The Vivally System represents a significant advancement in bladder control therapy as a non-invasive, patient-centered therapy providing patients with effective treatment, performed in the home, without the need for surgery or drugs,” said Dr. Colin Goudelocke, Principal Investigator for the FREEOAB Study. “In our study, significant reductions in symptom burden were observed at 12 weeks which, notably, persisted out to 12 months, even with a reduction in frequency of therapy sessions.” Read more.

Source: PRNewswire, November 15, 2023

Acupuncture for Women With Overactive Bladder

The most common symptom of an overactive bladder is a sudden, uncontrolled need or urge to urinate; followed by the need to urinate excessively throughout the day and night, independent of fluid intake. In women, causes of overactive bladder are varied, but the common consequence, beyond the physical manifestations, are frustration and embarrassment. While medications designed to relax the bladder remain a frontline treatment option, research continues to show the potential of nonpharmaceutical options – including acupuncture. Case in point: a 2023 research review that concludes acupuncture is effective and safe for treating overactive bladder. Read more.

Source: Acupunture Today, May/June 2023

Women’s Health Leader Elidah Launches Game-changing ELITONE URGE Device To Treat Overactive Bladder

Providing the same relief for overactive bladder (OAB) that they’ve become known for in the stress urinary incontinence arena, MedTech Elidah is excited to introduce their newest product, ELITONE URGE (https://elitone.com/products/), the first and only non-intrusive treatment for urge incontinence. This latest device, a natural successor to ELITONE, is specified to treat urgency bladder leaks that afflict 33 million women in the United States alone. ELITONE URGE is an external, non-implanted muscle stimulator that outputs signals to calm the muscles and nerves that cause urgency or OAB leaks. The patented design maximizes comfort and efficacy, while being discreet and wearable under clothes, for the perfect urge incontinence therapy. Read more.

Source: Globe Newswire, May 2, 2023

Clinical Study Results of the BlueWind System for Patients with Overactive Bladder Featured at the 2023 AUA Annual Meeting

BlueWind Medical, Ltd., the developer of a transformative implantable tibial neuromodulation therapy for Overactive Bladder (OAB), today announced results from the OASIS pivotal trial evaluating the safety and efficacy of the BlueWind System in the treatment of OAB. The results were featured in the late-breaking session (LBA01-05) at the American Urological Association (AUA) 2023 Annual Meeting in Chicago on Sunday, April 30^th. Read more.

Source: PRNewswire, May 1, 2023

Avation Medical Announces US FDA 510(k) Clearance for The Vivally® System

Avation Medical, Inc., the innovator in patient-friendly, closed-loop neuromodulation options to treat life-altering medical conditions, today announced that its Vivally System received US Food and Drug Administration (FDA) 510(k) clearance. Vivally is a non-invasive, bladder control therapy device and mobile application to treat patients with the conditions of urinary urgency and urge urinary incontinence (UUI) caused by overactive bladder (OAB) syndrome, without the need for surgery, drugs, or needle-electrodes. The Vivally System is the only closed-loop, non-invasive neuromodulation system for bladder control cleared for sale in the United States. Closed-loop control objectively confirms activation of the tibial nerve and continuously adjusts therapy parameters to ensure optimal output throughout the session. Read more.

Source: PRNewswire, April 11, 2023

Hydrogel-based Sensor Improves Outlook For People With Overactive Bladder

Overactive bladder syndrome (OBS) causes a frequent, uncontrolled urge to urinate, which can interfere with a person’s daily activities and affect their mental health. A new hydrogel-based device has been developed that can continuously monitor overactive bladders and has the potential to improve the treatment of the condition. Read more.

Source: New Atlas, March 13, 2023

Axonics Receives FDA Approval for Fourth-Generation Rechargeable Sacral Neuromodulation System

Axonics, Inc. (Nasdaq: AXNX), a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, today announced that the U.S. Food and Drug Administration has approved the company’s fourth-generation rechargeable sacral neuromodulation system. The newly approved Axonics R20^™ neurostimulator is labeled for a functional life in the body of at least 20 years and reduces how frequently a patient needs to recharge their implanted device to just once every 6 to 10 months for only one hour. Read more.

Source: BusinessWire, January 31, 2023

Zida LLC Recently Launched The Zida Control Sock to Help People Fight Against Incontinence

Zida has recently launched “The Zida Control Sock” to help individuals suffering from overactive bladder and incontinence reduce their symptoms. The Zida Control Sock is an FDA-cleared neuromodulation device that uses transcutaneous tibial nerve stimulation to treat overactive bladder and incontinence. Read more.

Source: Newsfile Corp., January 11, 2023

Myrbetriq Plus Pelvic Floor Exercises Fail to Ease Overactive Bladder

Combining Myrbetriq (mirabegron) with modifications like pelvic floor exercises failed to ease overactive bladder symptoms in people with Parkinson’s disease in a pilot clinical trial, the study’s main goal. But the treatment, approved for overactive bladder, when used with such behavioral modifications did increase the amount of urine patients were able to expel with each urination, relative to patients using only pelvic floor exercise. But this benefit was temporary. Read more.

Source: Parkinson’s News Today, December 7, 2022

Neuspera Medical® Announces First Successful Implant of the Nuvella™ System in the Second Phase of Its SANS-UUI IDE Clinical Trial

Neuspera® Medical, a medical device company developing implantable devices for patients battling chronic illnesses, today announced the first patient successfully implanted with the Nuvella™ system in its pivotal clinical trial (SANS-UUI). The procedure was performed by Dr. Jodi Michaels of Minnesota Urology, St. Paul, MN. The study will evaluate the safety and efficacy of the Nuvella system, designed to treat overactive bladder (OAB) with sacral neuromodulation (SNM) in patients with urinary urgency incontinence (UUI) symptoms. Read more.

Source: PRNewsire, October 10, 2022