Below you will find news and press releases from industry, government, and academia regarding product developments and medical/scientific research news.
Renovia Inc. (“Renovia”), a company dedicated to discovering and delivering first-line digital therapeutic and diagnostic devices for women with pelvic floor disorders, today announced it has launched a large, multi-center randomized controlled trial (RCT) to study the efficacy of a first-line non-surgical digital therapeutic for the treatment of stress-dominant urinary incontinence (UI). Pelvic floor muscle exercises (PFME), also known as Kegel exercises, are the widely accepted first-line conservative treatment for pelvic floor disorders including stress, urgency, and mixed UI within the urogynecology, urology and physical therapy communities. However, many women have trouble identifying and contracting the correct muscles when performing these exercises, and remembering to perform the exercises regularly can be challenging. Read more.
Source: Business Wire, November 12, 2018
According to the American Urological Association, approximately 40% of women and 30% of men live with overactive bladder or OAB. Many people with OAB find it difficult to talk to their doctor or loved ones about their condition because of the stigma associated with it. Pro-ficiency, a leading provider of interactive online patient education tools, announces its collaboration with the Academy for Continued Healthcare Learning (ACHL) and the Simon Foundation for Continence, in their joint, interactive program, to educate people about how to speak with their healthcare providers and their loved ones to get the care they need. The program also discusses treatment options, how to manage social and lifestyle considerations, and incorporating shared-decision making into visits with health care providers. The program is freely available to all participants. “ACHL & Pro-ficiency previously collaborated on a highly successful OAB educational activity, however, given the depth and breadth of OAB, it was clear that continued education was needed. ACHL is proud to continue the education movement with this most recent program,” adds Amanda Kaczerski, with ACHL. Read more.
Source: Newswire, November 5, 2018
Last week, The Journal of Urology published the feasibility data of Valencia Technologies’ (“Valencia“) eCoin™ device indicated for treatment of overactive bladder. The manuscript, “Feasibility of a fully-implanted, nickel-sized and shaped tibial nerve stimulator for the treatment of overactive bladder syndrome with urgency urinary incontinence,” details the design of Valencia’s 46 patient study and the study’s excellent clinical results. The manuscript has an embargo date of February 15, 2019. Implanted in a 20-minute office procedure across seven clinical centers in the United States and New Zealand, the coin-sized and shaped tibial nerve stimulator is distinctly simple to implant in stark contrast to a highly invasive and operator dependent therapy called sacral nerve stimulation. An author of the eCoin™ publication, Dr. Vincent Lucente, concludes, “I believe tibial nerve stimulation with eCoin™ will become the therapy of choice for patients after medications are tried. These early results clearly show a better therapy is on the horizon for patients with urinary incontinence.” Read more.
Source: PRNewswire, November 1, 2018
For a third year, the Urology Care Foundation, American Urological Association (AUA) and the Bladder Health Alliance – a coalition of groups representing physicians, patients and veterans – are drawing on the month of November to raise awareness about bladder conditions and encourage individuals to take an active role in managing their bladder health. Millions of Americans struggle with the impacts of such bladder conditions and disease as urinary incontinence, overactive and underactive bladder, interstitial cystitis, urinary tract infections, nocturia, bedwetting, bladder cancer and neurogenic bladder, on a daily basis. These conditions have a significant impact on an individual’s health and quality of life, and result in substantial health costs (estimated to be more than $70 billion per year). “Raising bladder health awareness and encouraging men and women to talk about their bladder health symptoms is a critical first step in eliminating the stigma associated with bladder-related conditions and disease,” said Harris Nagler, MD, President of the Urology Care Foundation. “It’s important for individuals to talk to their healthcare provider about what’s bothering them, including changes in their urinary function or urinary symptoms. Many times these conditions can be treated through simple lifestyle changes, oral medical treatments, diet and exercise.” Read more.
Source: PRNewswire, November 1, 2018
Nearly half of women over 50 say they sometimes leak urine — a problem that can range from a minor nuisance to a major issue — according to a new national poll. Of more than 1,000 women between the ages of 50 and 80 who answered the poll, 43 percent of women in their 50s and early 60s said they had experienced urinary incontinence, as had 51 percent of those age 65 and over. Yet two-thirds of these women hadn’t talked to a doctor about the sometimes embarrassing, little-discussed issue. And only 38 percent said they do exercises that can strengthen the muscles that can help keep urine in. The poll shows they’re finding ways of coping on their own – from using pads or special underwear to wearing dark clothing and limiting fluid intake. Read more.
Source: MHealth Lab, OCtober 31, 2018
Triple W, an innovator of connected health devices, today announced the U.S. launch of DFree®, the first wearable device for incontinence that notifies the user when it’s time to go to the bathroom. With DFree, seniors, children and disabled people with – bladder control issues have a convenient and cost-effective alternative to disposable diapers or pads and medications. DFree gives them freedom to live an active lifestyle with peace of mind from accidents. DFree has been used in over 500 senior care facilities in Japan and Europe since 2017. Triple W will showcase its new DFree device for consumer use at Medtrade, Georgia World Congress Center (Booth 2252), Oct. 16-17. Read more.
Source: PRWeb, October 16, 2018
Boston Scientific (NYSE:BSX) this week released three-year data from a study of its Solyx single incision sling system intended to treat stress urinary incontinence, touting that the trial met all primary and secondary endpoints. Boston Scientific said it presented the full results from the trial yesterday at the annual scientific symposium of the American Urogynecologic Society. The Marlborough, Mass.-based company said it enrolled a total 281 patients in the trial at 21 sites looking to compare efficacy and adverse events for non-inferiority of the Solyx system versus the gold-standard transobturator mid-urethral sling procedure. The study was part of a post-market surveillance trial required by the FDA to be performed by all manufacturers of mesh products, Boston Scientific said. The company touted it as the first of three such studies it will complete, with remaining data expected to be released next year. Read more.
Source: Mass Device, October 12, 2018