Latest Research, Industry, Medical and Scientific News
Urovant Sciences (Nasdaq: UROV) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application (NDA) for once-daily 75 mg vibegron for the treatment of patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. The NDA has been assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 26, 2020. In addition, the FDA has communicated that they are not currently planning to hold an Advisory Committee meeting to discuss the application. Read more.
Source: Businesswire, March 5, 2020
Viveve Medical, Inc. (VIVE), a medical technology company focused on women’s intimate health, announced today that it has completed enrollment in its three-arm, three-month feasibility study to compare Viveve’s Cryogen-cooled Monopolar Radiofrequency (CMRF) treatment and a cryogen-only sham treatment to an inert sham treatment for the improvement of stress urinary incontinence (SUI) in women. The Investigational Testing Application (ITA) study, approved by the Canadian Ministry of Health, was initiated in January 2020. Read more.
Source: Yahoo Finance!, March 4, 2020
Millions of people might eventually be spared the embarrassment and extreme isolation caused by wetting themselves, thanks to new research. One in every five people has a lower urinary tract disorder called overactive bladder which, for some, means not being able to hold in urine, needing to go to the toilet often, or waking in the night to empty their bladder. Some wear sanitary towels or disposable underwear, while others worry that even with absorbent underwear, they’ll smell of urine, so they choose instead to stay at home. Now, scientists at the University of Portsmouth have identified chemicals in urine that are specific to overactive bladder. The next step is to develop a gadget similar to a pregnancy test, to see if these chemical markers are present. Such a device is 12-24 months from clinical trials, but the early signs are encouraging. Read more.
Source: EurekAlert,, February 20, 2020
Urinary incontinence, associated with poor functioning of the muscles in the pelvic area, was found to have a negative impact on daily activities like walking and overall quality of life in people with multiple sclerosis (MS), a study shows. Adding pelvic floor muscle training to an MS treatment program may help to improve overall function, the researchers suggest, which could improve patient performance of daily life activities, especially in those with moderate or severe dependence on others. The study, “Pelvic floor dysfunction negatively impacts general functional performance in patients with multiple sclerosis,” was published in the journal Neurology and Urodynamics. Read more.
Source: Multiple Sclerosis News Today, February 18, 2020
Atlantic Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted over-the-counter (OTC) clearance to INNOVO®, a non-invasive, clinically proven and wearable device that treats the root cause of bladder weakness, known clinically as stress urinary incontinence (SUI). INNOVO® was previously available in the U.S. by prescription, with more than 3.5 million safe and successful therapy sessions delivered worldwide. Read more.
Source: Yahoo! Finance, February 6, 2020
Contura has earned FDA approval for an injectable hydrogel [Bulkamid] to treat stress urinary incontinence in women, according to a premarket approval order posted by the agency Monday. The permanently implanted device acts as a scaffold for cells to grow through, supporting the closing mechanism of the urethra for better control of urine. Approval of the Bulkamid implant was based on a study of 228 women that showed 75% of those who got the device reported dryness or improvement in their symptoms. Read more.
Source: MedTechDive, February 4, 2020