BlueWind Medical’s Revi™ System Secures U.S. FDA De Novo Classification Grant for the Treatment of Urgency Incontinence

BlueWind Medical, Ltd. today announced that the US Food and Drug Administration (FDA) granted a De Novo marketing request for the Revi System, a transformative tibial neuromodulation therapy for the treatment of the symptoms of urgency incontinence alone or in combination with urinary urgency. Physicians should follow clinical guidelines as applicable and should use their discretion to determine if Revi can be used before patients fail or not tolerate more conservative therapy. The De Novo grant is for men and women with urge urinary incontinence (UUI) and was based on results from the OASIS pivotal trial, in which Revi demonstrated statistically significant improvement in the reduction of symptoms of UUI compared to baseline and a favorable safety profile. Read more.

Source: PRNewswire, August 17, 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

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

Amber Therapeutics Announces Successful First-in-human Implants of Amber-UI: An Intelligent, Closed-loop Bioelectrical Therapy for Urge and Mixed Urinary Incontinence

Amber Therapeutics (‘Amber’ or the ‘Company’), a University of Oxford spinout developing next-generation, intelligent bioelectrical therapies to transform clinical outcomes in patients with functional disorders of the peripheral nervous system, announces that the first participants have been implanted with Amber-UI, the Company’s proprietary therapy for urge and mixed urinary incontinence (UI). Amber-UI is the first fully implantable closed-loop bioelectrical therapy in clinical development for UI, which is made possible by being able to access and target the pudendal nerve – the nerve that directly controls continence – through a novel, minimally invasive surgical procedure. Read more.

Source: PRNewswire, January 24, 2023

Prasterone Shows Promise In Reducing Severity of Urinary Urge Incontinence

Because of a decrease in estrogen, menopause is often accompanied by multiple vaginal and urinary issues. To date, most treatment options focus on vulvar and vaginal atrophy, with fewer options available to treat urinary incontinence. A new study, however, suggests prasterone is effective in improving the severity of urinary urge incontinence. Study results are published online today in Menopause, the journal of The North American Menopause Society (NAMS). Read more.

Source: Newswise, July 27, 2022

Valencia Technologies Announces FDA Approval of eCoin® Therapy to Treat Urinary Urge Incontinence

Valencia Technologies Corporation, a privately held company, today announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of its eCoin^® leadless tibial neurostimulator for the treatment of urinary urge incontinence (UUI), which affects over 60% of patients who suffer from Overactive Bladder (OAB). FDA approval was supported by the efficacy and favorable safety profile demonstrated in the eCoin^® pivotal trial. The company also announced the publication of these results in the Journal of Urology^®, the official journal of the American Urological Association. Read more.

Source: PRNewswire, March 2, 2022

Vibegron Update Shared as FDA Weighs Approval in OAB

The FDA is considering an application for vibegron for the treatment of patients with OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency. Vibegron continued to demonstrate improved clinical outcomes versus tolterodine in patients with overactive bladder (OAB), according to findings from an extension study of the phase 3 EMPOWUR trial presented during the 2020 International Continence Society (ICS) online meeting. The extension results showed that at week 52, 61% of patients receiving vibegron had a 75% or higher reduction in urge urinary incontinence (UUI) episodes compared with 54.5% of patients who received tolterodine. Additionally, 40.8% versus 34.2% of patients, respectively, had a 100% reduction in UUI episodes and experienced no incontinence episodes over a 7-day diary. Read more.

Source: Urology Times, November 20, 2020

Axonics® Announces U.S. Food & Drug Administration Approval for its Sacral Neuromodulation System for Urinary Clinical Indications

Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing novel implantable rechargeable sacral neuromodulation (“SNM”) devices for the treatment of bladder and bowel dysfunction, today announced the approval of the Axonics r-SNM® System by the United States Food & Drug Administration (“FDA”) for the clinical indications of overactive bladder (“OAB”) and urinary retention. The FDA premarket approval (“PMA”) grants Axonics the right to market its product in the United States for the clinical indications of OAB (urinary urge incontinence and urinary urge frequency) as well as urinary retention, representing the largest segment of the market for SNM devices. The FDA approval follows the Company’s September approval for the clinical indication of fecal incontinence, which, according to published clinical studies, is a co-morbidity reported by as many as a third of patients presenting with urinary urge incontinence. Read more.

Source: Business Wire, November 14 2019

CVD Factors, Especially High Blood Pressure, May Increase Risk of Severe Urge Incontinence

Patients with cardiovascular risk factors are more likely to also experience urgency urinary incontinence (UUI), according to UK researchers. They also said their study findings indicated that severe urgency UUI was a “distinct disease” from milder forms of the condition.The researchers, from University College London and King’s College London, looked at data on 1,762 participants in a Medical Research Council survey who reported having incontinence at the age of 68. The prevalence of urinary incontinence was 15% in men and 54% in women. UUI was the most common subtype in men, while there were similar proportions of UUI and stress urinary incontinence in women, with it being reported by 12% of men and 19% of women. Read more.

Source: Nursing Times online, March 9, 2018

Sleep Quality Improves with Help of Incontinence Drug

A drug used to curtail episodes of urinary incontinence in women also improves quality of sleep, a researcher at the Stanford University School of Medicine reports. People who experience urinary incontinence, especially at night, often have trouble maintaining normal sleep cycles. Now, the Stanford researcher sees promise in using one drug to help remedy both problems. “Two of the biggest quality-of-life factors for older women are poor sleep quality and incontinence, and the older you get, the more prevalent both conditions are, and they do seem to be correlated,” said Leslee Subak, MD, professor and chair of obstetrics and gynecology. “And so, if we can find a drug to treat one and effectively decrease the other too, that could be big for improving quality of life.” Read more.

Source: Stanford Medicine News Center, January 11, 2018

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