clinical medical

UroMems Reaches Significant Milestone: Successful Results in Clinical Feasibility Study of UroActive™ Smart Implant for Stress Urinary Incontinence Treatment

UroMems, a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today it has reached a significant milestone: the complete treatment cohort in the first-of-its-kind clinical feasibility study has successfully reached the six-month primary endpoints.  The feasibility assessment of the UroActive System was completed through a prospective multicenter clinical study. UroActive is the first smart automated artificial urinary sphincter (AUS) to treat SUI, and the only one to reach this critical milestone.  Read more.

Source: PRNewswire, December 13, 2023

women exercising

JUNOFEM Seeks FDA Approval for Innovative ‘femfit’ Incontinence Device in the US

JUNOFEM, a medical equipment supplier based in Auckland, New Zealand, has taken a significant step toward introducing their innovative ‘femfit’ female incontinence device to the American market by applying for FDA approval. After two years of dedicated work on their 510(k) pre-market submission, JUNOFEM aims to gain access to the US market upon FDA approval.  The femfit® Pelvic Floor Training Tool is a cutting-edge device designed for female pelvic floor muscle exercises. Read more.

Source: UniverseNews Network, December 7, 2023

product approval introduction

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

drugs for overactive bladder (OAB)

Black Patients Less Likely to Fill Prescriptions For Newer, Safer Urinary Incontinence Drugs

Millions of adults take medications to help relieve symptoms of overactive bladder and reduce episodes of urinary incontinence.  But research linking some of those medications called anticholinergic drugs, such as oxybutynin, to memory loss drove recommendations to treat urinary incontinence with beta-3 agonists, drugs that offer the same benefit but without the risk of cognitive decline.  A new study in JAMA Network Open led by Northwestern Medicine and Duke University School of Medicine shows Black patients are less likely to fill prescriptions for newer, safer urinary incontinence drugs compared to white patients, potentially raising their risk for dementia.  Read more.

Source: Duke University School of Medicine, June 12, 2023

leva Renovia

Digital Therapeutic Device for Urinary Incontinence

The prescription leva Pelvic Health System (Renovia) is the first device to offer a digital therapeutic therapy for pelvic floor muscle training to improve symptoms of urinary incontinence and fecal incontinence. In study findings published in Obstetrics & Gynecology, leva achieved significantly greater urinary incontinence symptom improvement than a standard home pelvic floor muscle training program at 6 and 12 months. Read more.

Source: Contemporary OB/GYN.net, March 8, 2023

nerve cells

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

measuring tape obesity

Weight-loss Surgery May Relieve Urinary Incontinence

Weight-loss surgery can have many health benefits, and now a new study suggests that long-term relief from urinary incontinence is one of them. Urinary incontinence (UI) is a common problem, and obesity is among the risk factors for it: Extra pounds put more pressure on the bladder and the muscles supporting it, which can cause urine to leak. Read more.

Source: UPI, December 14, 2022

operating room surgery

UroMems Initiates First-in-Human Study of Its Smart Implant to Treat Stress Urinary Incontinence

UroMems, a global company developing breakthrough, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully completed the first-in-human implant of the UroActive™ System, the first smart automated artificial urinary sphincter (AUS) investigational device to treat SUI. This initial clinical study is a key milestone in the development of UroActive. Read more.

Source: PRNewswire, November 29, 2022

Yoga App Eases in Incontinence in 4 Weeks

People with incontinence who used the Yoga of Immortals mobile app had significant improvement in the frequency and severity of urine leaks in four weeks, a new study shows. The globally used app combines specific yogic postures in the Sanatan tradition with breathing exercises, sound therapy, and meditation. Read more

Source: Futurity, July 27, 2022