Below you will find news and press releases from industry, government, and academia regarding product developments and medical/scientific research news.
TARIS Bio™, a biopharmaceutical company developing transformational therapies to treat people with debilitating urological disorders, announced today the initiation of a new clinical investigation of TAR-302 for the treatment of overactive bladder (OAB). As a new follow-on arm of the company’s previously concluded Phase 1b trial, the study is designed to investigate the safety, tolerability, and preliminary efficacy of a single 12-week dose of the system, doubling the previous treatment experience and representing a duration that better meets the real-world needs of patients with this serious and chronic disease. Read more.
Source: Yahoo! Finance, May 1, 2019
The American Urological Association (AUA) announced that it has updated its guideline for the diagnosis and treatment of non-neurogenic overactive bladder (OAB) in adult patients. As a result of a 2018 systematic review of recently published studies, AUA modified guideline statement 12 to say clinicians may consider combination therapy with an antimuscarinic agent and beta3-andrenoceptor agonist for patients who are refractory to monotherapy with either of those medications. Read more.
Source: Renal & Urology News, April 25, 2019
For Gruff, double incontinence has made some days at secondary school an anxious and humiliating experience. Campaigners claim there is a lack of support in Wales, estimating that 1 in 10 UK children suffer bedwetting, daytime accidents and constipation. The Welsh Government said it expected health boards to provide specialist-led continence services for under-19s. Read more.
Source: BBC News, April 25, 2019
Over 80 million adults in the U.S. manage some level of urinary or bowel incontinence, and many millions more will be faced with leaks and loss of control later in life. The good news is many of these symptoms are treatable or can be managed using incontinence pads bought in stores. But what if that isn’t enough? For people who have heavy incontinence and need stronger, more absorbent products than those found in stores, their options have been limited to clinical hospital-like briefs. Until now. Earlier this year, NorthShore Care Supply, a Buffalo Grove Illinois-based company founded to empower those with heavy bladder or bowel leakage, unveiled its popular SupremeLite™ absorbent brief, now in vibrant shades of blue, green and purple. Read more.
Source: Newswire.com., April 23, 2019
The U.S. Food and Drug Administration on Tuesday announced a ban on the sale of all pelvic mesh products. The surgical mesh is typically used to repair pelvic organ prolapse (POP) and incontinence, but reported side effects have included permanent incontinence, severe discomfort and an inability to have sex. “In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term.” Read more.
Source: HealthDay News, April 16, 2019
Atlantic Therapeutics, a company out of Galway, Ireland, will soon be releasing its INNOVO transcutaneous electrical stimulator to treat stress urinary incontinence in women. The device was FDA approved late last year as the first transcutaneous stimulator with such an indication. It delivers electric current through the body toward muscles that control the pelvic floor, which in turn can help maintain continence. The technology provides women a non-invasive option that, in a clinical trial, demonstrated that 87% of women were dry or nearly so after a three month treatment. 80% of the women studied had results after only a month or therapy. Read more.
Medgadget, April 11, 2019
InControl Medical wins FDA clearance for new Attain, the first over-the-counter (OTC) non-implantable muscle stimulator designed for at-home use to help treat the approximately 60 million women in the U.S. suffering with stress, urge, mixed urinary incontinence and/or bowel incontinence. This is good news for all those affected by urinary and/or involuntary bowel leakage that can increase with age: 20% -30% of young women, 30%-40% of middle-aged women, and up to 50% of older women suffer from incontinence. It’s time to talk about this taboo topic before diapers become the newest accessory in the Nike store. So, strengthen your calves and abs, but don’t forget to strengthen your pelvic floor muscles too, says Lauren Streicher, M.D., Medical Director of the Northwestern Medicine Center for Sexual Health and Menopause and Clinical Professor of Obstetrics and Gynecology at Northwestern University. All kidding aside, many of my patients who suffer with urinary incontinence, can also have leaky bowel, and truly suffer in silence and embarrassment. Post-partum, anal or rectal cancer, and the natural aging process can cause incontinence. Thankfully, many patients respond well to pelvic-floor electrical stimulation and biofeedback as a first-line treatment, before considering surgery or medication. Attain is a small, painless, easy to use medical device for women to self-treat in the privacy of their own home, reducing or eliminating the need for pads or diapers. Read more.
Source: Global Banking & Finance Review, March 26, 2019