Below you will find news and press releases from industry, government, and academia regarding product developments and medical/scientific research news.
Urovant Sciences Announces U.S. FDA Approval of GEMTESA® (vibegron) 75 mg Tablets for the Treatment of Patients with Overactive Bladder (OAB)
Urovant Sciences, Inc (Nasdaq: UROV) announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for once-daily 75 mg GEMTESA® (vibegron), a beta-3 adrenergic receptor (β3) agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults. Read more.
Source: BioSpace, December 23, 2020
Vibegron Update Shared as FDA Weighs Approval in OAB
The FDA is considering an application for vibegron for the treatment of patients with OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency. Vibegron continued to demonstrate improved clinical outcomes versus tolterodine in patients with overactive bladder (OAB), according to findings from an extension study of the phase 3 EMPOWUR trial presented during the 2020 International Continence Society (ICS) online meeting. The extension results showed that at week 52, 61% of patients receiving vibegron had a 75% or higher reduction in urge urinary incontinence (UUI) episodes compared with 54.5% of patients who received tolterodine. Additionally, 40.8% versus 34.2% of patients, respectively, had a 100% reduction in UUI episodes and experienced no incontinence episodes over a 7-day diary. Read more.
Source: Urology Times, November 20, 2020
Essity Launches Pilot of Digital Incontinence Solution
Hygiene and health company Essity, which makes TENA incontinence and skincare products, has launched a pilot program of its TENA SmartCare Change Indicator, a system that uses digital sensors and a smartphone app to reduce manual checks of incontinence patients. Cleared by the U.S. Food and Drug Administration (FDA) earlier this year, SmartCare Change Indicator notifies caregivers via smartphone when they should consider changing a patient’s TENA absorbent products. Read more.
Source: HME Business, October 29, 2020
UH Researcher Receives $1.6 Million to Reverse Urinary Incontinence
A University of Houston researcher is working to reverse pelvic floor dysfunction which can result in urinary incontinence, a condition affecting 30-60% of the female population and 5-15% of males. Stress urinary incontinence (SUI), the most common type of urinary incontinence in women, relates to the unintentional loss of urine which happens during movement or activities like sneezing, coughing or exercising. The condition is associated with pregnancy and aging and affects the pelvic floor, a group of muscles stretching from the pubic bone to the tail bone that contributes to continence. Read more.
Source: News-Medical.Net, October 15, 2020
To Tell or Not To Tell – An Incontinence Disclosure Toolkit
Incontinence disclosure? Many have found it liberating to speak openly about their bladder control problems. Others are more comfortable keeping their incontinence secret. What is the right path for you?
There is no right or wrong answer – only what is best for you now. How will your choices affect your personal relationships?
Your social interactions? Your work? Disclosing or concealing incontinence can be a complex and difficult decision.
To Tell or Not To Tell is a free incontinence disclosure toolkit created by The Simon Foundation and an amazing advisory team.
To Tell or Not To Tell is designed for people who want to think more about disclosing their incontinence to others. This program is not meant either to pressure you to disclose or to discourage you from disclosing; rather it is meant to help guide you through the decision-making process, challenge any embarrassment you might be imposing on yourself, and allow you to hear the story of others whose lives have been impacted by incontinence.
In addition to providing the toolkit for free, The Simon Foundation also offers live online workshops guided by a trained Life Coach.
Axonics® Reports 2-Year Clinical Results from ARTISAN-SNM Pivotal Study
Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, has reported full 2-year clinical results from its ARTISAN-SNM pivotal study. Read more.
Source: Business Wire, September 10, 2020
An Emerging Link Between the Urinary Microbiome and Urinary Incontinence
Most people know that microorganisms live on our skin, and in other places in the body such as the digestive tract. However, traditional thinking and medical teaching was that there was no such microbiome in the urinary tract. Many people may still believe that urine is sterile. Advanced detection methods such as enhanced urine cultures and DNA sequencing have shown that this is not true. Read more.
Source: Harvard Health Blog, August 12, 2020