Below you will find news and press releases from industry, government, and academia regarding product developments and medical/scientific research news.
Behavioral therapies relieve stress, urgency, and mixed urinary incontinence (UI) more effectively than drug monotherapies in nonpregnant women. In a new systematic review and network meta-analysis (NMA) of 84 randomized trials published in theAnnals of Internal Medicine, most interventions including combination therapies improved or resolved women’s symptoms better than no treatment, whether sham or watchful waiting, Ethan Balk, MD, MPH, of Brown University in Providence, Rhode Island, and colleagues reported. Hormones and periurethral bulking agents appeared less than effective, however. Read more.
Source: Renal & Urology News, March 20, 2019
Investors who backed Urovant’s $140m flotation last September will soon find out whether the money was well spent. Before the end of March the company will release topline pivotal data on the overactive bladder project vibegron, a β3-adrenergic receptor agonist licensed from Merck & Co, and a positive result should allow regulatory filings to follow. It seems likely that the trial will hit: Merck successfully conducted a large phase IIb study of vibegron a few years ago, and a similar compound is already on the market in the shape of Myrbetriq, which has been sold by Astellas since 2011. This well-established product has only four years of US patent life left, so if Urovant has any chance of building vibegron into a similarly large product it needs to prove that its contender is both safer and more effective. Read more.
Source: Evaluate, March 12, 2019
A spokesperson said: “BD has decided to discontinue the manufacture and sale of pelvic organ prolapse and stress urinary incontinence products in all remaining markets worldwide. While thousands of women over many years have benefited from the safe use of these products, we have decided to stop production of these devices to focus on other strategic priorities rather than continue to invest in clinical data to support additional EU requirements.” The government website says there is no need for implanted devices to be removed and no additional follow-up is required for patients implanted with such devices but anyone who has any concerns about their implanted device should contact their GP. Read more.
Source: Medical Plastics News, March 7, 2019
Skilled nursing educators worth their mettle today will strongly warn bedside caregivers to throw out any preconceived notions they may have about incontinence. A big one is the widely disproved notion that incontinence is an “old person’s disease.” Another one is that “incontinence cannot be cured.” In a recent study, in fact, significant numbers of professional nurses and a vast majority of nurse assistants told Indiana University researchers they believed bladder disorders are a normal part of aging. Time and again, researchers have refuted incontinence mythology. Along the way, their efforts all too often show how frail elderly individuals can quickly tumble down a path of declining health, endless indignities and painful bed sores. That is, if open minds and a thorough assessment had not prevailed before a resident’s head hit the pillow for the first time. Read more.
Source: McKnight’s Long-term Care News, March 7, 2019
Safe Medical Design, a company based in San Francisco, CA, won FDA clearance for its Signal Catheter device. The indwelling foley urinary catheter is designed to help prevent discomfort and injury that can occur if it’s incorrectly placed, an all-too-common occurrence. Indwelling urinary catheters typically have a balloon at the tip that is inflated once it’s within the bladder. This prevents the catheter from sliding out. When the patient is “dry” and no urine is in the catheter, it’s often difficult to tell whether the catheter tip made it into the bladder, at times resulting in premature inflation that can cause serious trauma. The Signal Catheter is made of 100% silicone and it features a mechanism that relieves the pressure inside the balloon if it is improperly positioned and inflated inside the urethra. Read more.
Source: Medgadget, March 1, 2019
Tepha has announced the initiation of a pilot clinical evaluation of the Company’s P4HB regenerative polymer scaffold for the surgical treatment of stress urinary incontinence (SUI). The study was initiated in Cape Town, South Africa in partnership with the Pelvic Floor Foundation of South Africa(“PFFSA”) and the University of Cape Town. The first procedures were performed by co-principal investigators, Dr. Stephen Jeffery of the University of Cape Town and Professor Jan-Paul Roovers of the Academic Medical Center, Amsterdam, The Netherlands. The Cape Town SUI study represents the first clinical application of Tepha’s P4HB polymer technology in the field of urogynecology. Based in Lexington, MA, Tepha is the pioneer developer and exclusive supplier of the P4HB polymer for medical applications that include hernia repair, plastic surgery, tendon & ligament repair, and wound closure. Read more.
Source: Compelo, February 28, 2019
Hollister Incorporated, a US-based company that develops, manufactures, and markets healthcare products and services worldwide, has launched the Infyna Chic intermittent catheter, the latest in the company’s line of female hydrophilic catheter products. Designed to help provide women who use catheters with a high level of discretion, the new catheter received CE approval in December 2018. The Infyna Chic catheter will be joining the Infyna Standard and Plus catheters to complete the Infyna portfolio, offering women a range of options to meet their individual needs. In the coming months, the product will be available in Europe and Canada. Read more.
Source: PRNewswire, February 27, 2019