GRAMINEX®, L.L.C. Final Publication of a Peer Reviewed Clinical Trial with Graminex® Flower Pollen Extract Focusing on Women’s Urinary Incontinence in Current Urology

Graminex®, L.L.C. is pleased to announce publication of a peer reviewed clinical study with Graminex® Flower Pollen Extract for women’s urinary incontinence and urinary health in Current Urology. The study was conducted as a randomized, double-blind, placebo-controlled study to investigate the effectiveness of Graminex® Flower Pollen Extracts in 114 healthy women with urinary incontinence.  Read more.

Source: Business Wire, May 13, 2024

nurse and patient

Published Data Demonstrate Excellent Safety and Efficacy and Reinforce Patient Satisfaction with Revi™ System in the Treatment of Urge Urinary Incontinence

BlueWind Medical, Ltd., a pioneer in implantable Tibial NeuroModulation (iTNM) and the developer of ReviTM, a patient-centric solution for urge urinary incontinence (UUI), today announced that the peer-reviewed results from the OASIS pivotal trial were published in the Journal of Neurourology and Urodynamics (NAU). OASIS, a prospective, multicenter, single-arm, open-label clinical study of 151 women, was designed to demonstrate the safety and efficacy of Revi in reducing symptoms of overactive bladder (OAB).  The trial results demonstrate a statistically significant improvement with a 78.4% clinical success rate as defined by at least a 50% reduction in UUI at 12 months in the intention to treat (ITT) analysis (p<.0001). Read more.

Source: PRNewswire, April 23, 2024

nerve cells

Amber Therapeutics Announces Positive Preliminary Results From Its First-In-Human Investigation of Amber-UI, Its New Adaptive Implanted Pudendal Neuromodulation System for Urinary Incontinence

Amber Therapeutics (‘Amber’ or the ‘Company’), an innovative medical technology company developing next-generation, intelligent bioelectrical therapies to transform clinical outcomes in patients with functional disorders of the peripheral nervous system, announces the presentation of the first data from its AURA-2 (Augmenting Urinary Reflex Activity) first-in-human study evaluating Amber-UI.  Amber-UI is the first fully implantable closed-loop bioelectrical therapy in clinical development for urinary incontinence (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: WWLP.com, February 27, 2024

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