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

Dementia, Incontinence and the Loss of Dignity in Acute Hospitals

Continence care for people with dementia in acute wards has been described both as a “crisis of dehumanization” and a “key moment of care” that can reveal a great deal about the wider hospital care of this highly vulnerable population (Boddington and Featherstone, 2018). “The challenge of continence care for people living with dementia can be seen as the ‘canary in the coal mine’ for the unravelling of dignity within the acute setting” (Boddington and Featherstone, 2018). Read more.

Source: Nursing Times, March 13, 2023

Hydrogel-based Sensor Improves Outlook For People With Overactive Bladder

Overactive bladder syndrome (OBS) causes a frequent, uncontrolled urge to urinate, which can interfere with a person’s daily activities and affect their mental health. A new hydrogel-based device has been developed that can continuously monitor overactive bladders and has the potential to improve the treatment of the condition. Read more.

Source: New Atlas, March 13, 2023

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

Dignify Therapeutics Receives NIH Award for Preclinical and Clinical Development of a Novel, On-Demand, Voiding Therapy

Dignify Therapeutics LLC, a pharmaceutical and medical device development company focused on restoring bladder and bowel control for people with spinal injury, multiple sclerosis, diabetes, and the elderly, was awarded the prestigious Blueprint Neurotherapeutics Network grant from the National Institutes of Health (NIH). This 4-year award provides over $4 million in funding to support preclinical and clinical development of the Company’s lead drug candidate, DTI-117, to treat bladder and bowel dysfunction. “This new award exemplifies the foresight of, and commitment from, the NIH to develop treatments for bladder and bowel dysfunction in people suffering from these conditions” said company President and Principal Investigator, Dr. Ed Burgard. “This award will provide funds for an IND submission and a subsequent clinical trial for DTI-117”. Read more.

Source: Dignify Therapeutics website, February 27, 2023

Decades-Long Suffering From Obstetric Injuries

Bowel leakage, the need for anal incontinence protection and a restricted social life may cause severe, decades-long suffering among women with obstetric injuries to the anal opening, according to a study from the University of Gothenburg. The study, published in the American Journal of Obstetrics and Gynecology, comprises a total of more than 11,000 women who had given birth vaginally in Sweden, twice, in the years 1987-2000. Read more.

Source: Science Daily, February 23, 2023

Over Half of Men Experience Some Symptoms of Urinary Incontinence, Study Finds

Over half of men in the UK have experienced some symptoms of urinary incontinence (UI) while previous studies may have underestimated the true number of men affected, the charity Prostate Cancer UK has suggested. A study found that awareness of urinary incontinence in men in the general population was lower than the prevalence of the condition would suggest. While previous research has suggested that one in 25 men over 40 will experience UI each year in the UK, Prostate Cancer UK’s survey of almost 5,000 people found that the condition could be much more common, and often affected men much earlier in their lives than had previously been believed likely. Read more.

Source: Nursing in Practice, Feburary 15, 2023

Coloplast Launches Male Catheter Designed to Reduce the Risk of Urinary Tract Infections

The new intermittent catheter Luja™ addresses important risk factors for urinary tract infections, a significant burden for people using intermittent catheters as well as healthcare systems as a whole. Urinary tract infections represent a significant challenge for people who use intermittent catheters to empty their bladder. This includes people living with spinal cord injury, multiple sclerosis, or spina bifida. On average, intermittent catheter users have 2-3 urinary tract infections per year, which can lead to serious health complications, have a significant impact on quality of life, and result in hospitalisation, thereby putting pressure on local healthcare systems. Read more.

Source: Yahoo News, February 2, 2023