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

Medtronic Receives FDA Approval for InterStim X™ System

Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced it received approval from the U.S. Food and Drug Administration (FDA) for InterStim X™ ― the next generation of the InterStim™ portfolio’s recharge-free device – and it is available immediately. InterStim systems are the standard of care in advanced therapy options, and the most personalized system, to deliver sacral neuromodulation (SNM) therapy. Now the only SNM system backed by 90+ clinical studies, 1,000+ clinical articles, 350,000 patients treated and 25 years of experience, also offers patients a decade or more of treatment with either the new recharge-free InterStim X device, or the rechargeable InterStim™ Micro device. Both devices are used in the treatment of overactive bladder (OAB), chronic fecal incontinence (FI), and non-obstructive urinary retention. Read more.

Source: PRNewswire, February 22, 2022

How OnabotulinumtoxinA “Revolutionized” Treatment of Urologic Conditions

Urology Times® is celebrating its 50th anniversary in 2022. To mark the occasion, we are highlighting 50 of the top innovations and developments that have transformed the field of urology over the past 50 years. In this installment, Melissa R. Kaufman, MD, PhD, FACS, discusses the significance of onabotulinumtoxinA treatment in patients with overactive bladder. Dr. Kaufman is a Professor of urology, Patricia and Rodes Hart Endowed Chair of Urologic Surgery, and Chief of Reconstructive Urology and Pelvic Health at Vanderbilt University Medical Center, Nashville, Tennessee. Read more.

Source: Urology Times, February 16, 2022

EvidenceNOW: Managing Urinary Incontinence

In February 2022, AHRQ launched the Improving Nonsurgical Treatment of Urinary Incontinence among Women in Primary Care (INTUIT-PC). The initiative builds on AHRQ’s EvidenceNOW Model of external support to help primary care practices implement patient-centered outcomes research (PCOR) on effective nonsurgical interventions for UI such as behavioral approaches, medications, and neuromodulation. The initiative will help close the gap between evidence and primary care practice in care for UI in women. Read more.

Source: U.S. Agency for Healthcare Research and Quality, February 2022

New Study Finds More Than 60% of Adult Women in the U.S. Experience Urinary Incontinence

Axonics, Inc., a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, today highlighted the publication of a new study that provides updated estimates of urinary incontinence (UI) prevalence in the U.S. The study, titled “Updated Prevalence of Urinary Incontinence in Women: 2015-2018 National Population-Based Survey Data,” was published in the peer-reviewed journal Female Pelvic Medicine & Reconstructive Surgery, the official journal of the American Urogynecologic Society (AUGS). Study authors at the University of Wisconsin School of Medicine and Public Health utilized publicly available data from the 2015-2018 National Health and Nutrition Examination Survey (NHANES) sample and included over 5,000 women who completed mobile examinations and computer-assisted personal interviews with standardized UI questions. Read more.

Source: Business Wire, January 25, 2022

Caldera Medical Announces FDA Clearance for New Desara® TVez for Stress Urinary Incontinence

Caldera Medical, a medical device company that develops best-in-class surgical products for the treatment of Stress Urinary Incontinence, Pelvic Organ Prolapse, and Polyps announced the launch of Desara^®TVez, an expansion to their Desara^® Family of products. Caldera Medical, a medical device company that develops best-in-class surgical products for the treatment of Stress Urinary Incontinence, Pelvic Organ Prolapse, and Polyps announced the launch of Desara^®TVez, an expansion to their Desara^® Family of products. Read more.

Source: Business Wire, December 2, 2021

Individual Pessaries For More Successful Treatment Of Stress Incontinence Through 3D Printing

Simply Standing up, doing sports, or just laughing, it’s extremely unpleasant whenever urine suddenly leaks uncontrollably. Colloquially referred to as a ‘weak bladder’, it’s known as Stress Urinary Incontinence in medical terms. Although about one in three women suffers from uncontrolled urine leakage, incontinence is still taboo. Initially merely a physical problem, it also quickly weighs on the soul. For fear of unpleasant situations, those affected often withdraw and avoid social activities with families and friends. 3D printed pessaries may relieve the burden. Read more.

Source: The Science Times, November 14, 2021

Let’s talk: Post-acute rehab patients need to be looped in about incontinence care, study finds

Post-acute care nurses are right on target with continence assessment and management, a new study finds. But their patients are largely unaware of these activities and think they’re going it alone, investigators say. The researchers conducted interviews with 10 nursing staff and 10 patients in two geriatric units of a rehabilitation hospital. Perhaps not surprisingly, nurses and patients had very different experiences of incontinence care. Read more.

Source: Urology Times, November 12, 2021

Study Finds Vibegron Has No Adverse Ambulatory Effects in Patients with OAB

It is important for clinicians to perform ambulatory blood pressure monitoring (ABPM) for patients taking new prescribed medications, as they may affect blood pressure or heart rate in detrimental ways. It is especially important to monitor patients with overactive bladder (OAB), as this group has an increasing abundance of novel medicines available to them. In a recent study presented at the 2021 American Urological Association Annual Meeting,¹ Michael A. Weber, MD, and co-authors assessed the blood pressure and heart rate profiles of the beta 3 adrenergic receptor agonist vibegron (Gemtesa) in treating patients with OAB. Read more.

Source: Urology Times, November 5 2021

Principle Business Enterprises and Elizabeth Dole Foundation Provide Relief for Hundreds of Veterans, Family Caregivers

Principle Business Enterprises, Inc., (PBE), which manufactures Tranquility® superabsorbent products, and the Elizabeth Dole Foundation, a prominent military Caregivers advocacy group, have partnered to provide Veterans and their families free in-home help. Their joint campaign themed “Relief and Freedom for Veteran Caregivers” encourages Caregivers of wounded, ill or injured service members to apply for free respite support and, for those with absorbent product needs, a customized incontinence care kit at TranquilityProducts.com/Respite. Read more.

Source: PRNewswire, November 1, 2021