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

World’s First Bladder Transplant Will Be Performed By Both Human and Robot Surgeons

A team of urologists at Keck Medicine of the University of South California (USC) is conducting a clinical trial that will soon lead to the first-ever bladder transplant operation in humans. The doctors are currently in the process of selecting participants for their trials. If successful, such operations would provide relief to millions of people around the globe who live with bladder-related disorders. Inderbir Gill, principal investigator and executive director at Keck Medicine USC Urology, said, “We could be on the verge of a medical advance that has the potential to revolutionize how we treat terminally compromised bladders.” Read more.

Source: Interesting Engineering, 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

AUA, SUFU Release an Amendment to the Female Stress Urinary Incontinence Guideline

Today, the American Urological Association (AUA), in partnership with the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU), released the 2023 clinical practice guideline amendment for the surgical treatment of female stress urinary incontinence (SUI). SUI is a common problem experienced by many women. About 1 in 3 women suffer from SUI at some point in their lives, and the chance of having urinary incontinence increases with age. The updated guideline has 24 recommendations that provide a clinical framework for the assessment and treatment of SUI in women. Read more and access the new guideline.

Source: PRNewswire, April 25, 2023

Axonics Acquires Tech to Expedite Placement of Implantable Leads in Sacral Neuromod

Axonics (Nasdaq:AXNX) today announced it acquired lead placement technology from Radian to speed up the placement of implantable leads for sacral neuromodulation. Axonics acquired the assets of Radian from Intermed Labs for an undisclosed amount. The company expects the product to receive FDA clearance and be available on a commercial basis in mid-2024. Read more.

Soure: MassDevice.com, April 24, 2023

UroMems Granted Safer Technologies Program Designation from FDA for Smart Implant to Treat Stress Urinary Incontinence

UroMems, a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that they have received Safer Technologies Program (STeP) designation from the U.S. Food and Drug Administration (FDA) for UroActive Smart Continence Therapy. STeP is a collaborative program intended to help reduce the time it takes to develop and obtain marketing authorization for eligible devices. Read more.

Source: PRNewswire, April 20, 2023

woman pushing another woman in wheelchair caregiver

Touching Film for TENA Goes Behind Closed Doors to Show the Reality of Family Carers

Around one in ten people already look after a loved one [1], yet new research conducted by Essity owned incontinence brand TENA reveals that only 50% of people who provided extended family care considered themselves a ‘carer’. This lack of perception is largely down to those doing the care not acknowledging themselves as ‘carers’ and, as a result, they feel more alone and unaware of the support available. The research, conducted with Ketchum, is part of TENA’s new global campaign #NoLoveLikeIt, which sees the brand also partnering with Carers UK. Committed to providing care for both caregiver and receiver, TENA delved deep into qualitative and quantitative research to understand the realities of caring, which will become a reality for most of us at some point, as populations age and more care is provided in home by families. Read more.

Source: lbbonline, April 12, 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

Florida Faces Medicaid Class Action Lawsuit

A judge has cleared the way for a class-action lawsuit alleging that Florida’s Medicaid program has violated federal laws by denying coverage for incontinence supplies for adults with disabilities. U.S. District Judge Marcia Morales Howard issued a 37-page decision granting a request by attorneys for two women and the organization Disability Rights Florida to handle the case as a class action. While it is not clear how many people the case could affect, the decision cited one estimate that at least 480 Medicaid beneficiaries a year turn 21 and lose coverage for incontinence supplies that they received as children. Read more.

Source: CBS Miami, April 10, 2023

Urology Fellowship Program Celebrated After 20 Years

A two-year urology fellowship training program focused on women’s urologic health and reconstruction, known as Female Pelvic Medicine and Reconstructive Surgery (FPMRS), is celebrating its 20th anniversary and graduating its 20th fellow in June at Vanderbilt University Medical Center. FPMRS fellows, selected one per year after completing a urology residency, spend two years learning to manage adult patients with urinary and pelvic conditions including urinary incontinence, pelvic organ prolapse, voiding dysfunction and neurogenic lower urinary tract dysfunction. Additional aspects of pelvic and urinary reconstruction include surgical repair of urinary fistulas, diverticular disease, urinary diversion and cancer survivorship. FPMRS is a multidisciplinary subspecialty that includes both urologists and gynecologists, all of whom complete the same fellowship-level training regardless of background. Read more.

Source: VUMC Reporter, March 30, 2023