product approval introduction

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

female doctor

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

depression elderly nursing home

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

autonomic nerves

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

Incontinence Disclosure Toolkit

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.

clinical medical

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

microbiologist at laboratory work

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

product approval introduction

FDA Approves New Devices for Bladder and Bowel Control Conditions

The FDA has approved the InterStim Micro neurostimulator and InterStim SureScan MRI leads for the treatment of patients with bladder and bowl control conditions, according to Medtronic plc, the manufacturer of the devices.  InterStim Micro treats patients with overactive bladder, fecal incontinence, and non-obstructive urinary retention by delivering sacral neuromodulation (SNM) therapy. SNM sends “electrical impulses to the sacral nerves located in the lower back to improve bladder and bowel control. Read more.

Source: Urology Times, August 6, 2020

clinical medical

Viveve Announces FDA Approval to Conduct PURSUIT Trial for Improvement of Stress Urinary Incontinence

Viveve, Inc. (NASDAQ:VIVE), a medical technology company focused on women’s intimate health, announced today that the Company has received approval of its Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin a stress urinary incontinence (SUI) multicenter, randomized, double-blinded, sham-controlled clinical trial entitled PURSUIT – Prospective U.S. Radiofrequency SUI Trial. The trial is designed to evaluate the safety and efficacy of Viveve’s Cryogen-cooled Monopolar Radiofrequency (CMRF) treatment versus an inert sham tip for the improvement of SUI in women. Read more.

Source: BioSpace, July 7, 2020

product approval introduction

Rigicon Launches Two New Artificial Urinary Sphincter Systems for Incontinence Treatment

Rigicon announces that ContiClassic® Artificial Urinary Sphincter and the ContiReflex® Artificial Urinary Sphincter models have recently received CE Mark Approval and is initially available in all major European markets.  ContiClassic® Artificial Urinary Sphincter and ContiReflex® Artificial Urinary Sphincter are implant devices that treat Urinary Incontinence (UI). Conti® Artificial Urinary Sphincter Systems are indicated to treat urinary incontinence due to intrinsic sphincter deficiency in cases such as incontinence following prostate surgery. Conti® Artificial Urinary Sphincter Systems are designed to restore the function of the normal (healthy) urinary sphincter that restricts urine flow out of the bladder. Read more.

Source: PRWeb, May 7, 2020