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

Urinary Implant Helps Patients With Incontinence Track Bladder Fullness

It’s hard for some folks who suffer illness-related urinary incontinence to judge whether they’ll be able to hold it until they get home, or if they should rush to a bathroom now.  There might soon be a new app for that.  A newly developed soft, flexible, battery-free implant attaches to the bladder wall and senses the organ filling with urine, according to researchers at Northwestern University in Chicago.  The implant wirelessly transmits data to a smartphone app, so patients can track their bladder fullness in real time, researchers said. Read more.

Source: UPI, March 26, 2024

Bacteria

How Urobiome Composition Impacts Urinary Incontinence

A urobiome community type with fewer Lactobacilli and more diverse bacteria is associated with more severe urinary incontinence (UI) episodes vs a type with high predominance of a single genus, Lactobacillus, according to a recent study published in the American Journal of Obstetrics & Gynecology. Bacteria has been categorized into various niches, including the bladder niche and adjacent vaginal niche in women. Sequencing methods allow for urothelial and squamous intracellular bacteria to be identified. These bacteria may serve as reservoirs for chronic conditions such as urinary tract infection (UTI). Read more.

Source: Contemporary OB/GYN, March 19, 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

UroMems Announces Results of First-Ever Smart Artificial Urinary Sphincter Implant in Female Patient to Treat Stress Urinary Incontinence

UroMems, a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully met the six-month primary endpoint for the first-ever female patient implanted with the UroActive™ System, the first smart automated artificial urinary sphincter (AUS) to treat SUI. This milestone indicates a new era for millions of women suffering from SUI, and signals an exciting transition for surgeons treating SUI not only in France, where the female patient was treated, but also across Europe and the U.S. Read more.

Source: PRNewswire, February 14, 2024

Could Botox Injections Help Patients…Down There? A New Study Suggests That Botox Can Help with Fecal Incontinence

Researchers are testing rectal injections of Botox to see whether they might help patients manage fecal incontinence—so far, results are promising. If future studies confirm success, doctors could provide patients with new ways to manage this hard-to-control condition.  In a randomized, double-blind, placebo-controlled study, researchers treated nearly 200 patients for fecal incontinence using Botox or a placebo. Ninety-six patients received Botox, and 95 received the placebo treatment after nine patients withdrew from the trial before receiving injections.  Read more.

Source: MDLinx, January 29, 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

drugs for overactive bladder (OAB)

Versameb AG Announces FDA Clearance of IND Application for VMB-100 in the Treatment of Stress Urinary Incontinence

Versameb AG (“Versameb”), a pre-clinical stage company focused on transforming RNA therapeutics to treat unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application of VMB-100, a potency enhanced messenger ribonucleic acid (mRNA) encoding human insulin-like growth factor-1 (IGF-1), for the treatment of stress urinary incontinence (SUI).  Following this clearance, Versameb plans to launch a Phase 2a open label, first-in-human dose ascending study in the first half of 2024. The study will evaluate the safety, tolerability, and efficacy of VMB-100 in female subjects with stress urinary incontinence, a highly common condition resulting in involuntary leakage of urine due to a weakened urinary sphincter muscle. Read more.

Source: Pharmaweb.com, November 17, 2023

clinical medical

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