Research, Industry, Medical and Scientific News

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Below you will find news and press releases from industry, government, and academia regarding product developments and medical/scientific research news.

drugs for overactive bladder (OAB)

Urovant Sciences Announces U.S. FDA Acceptance of New Drug Application for Vibegron for the Treatment of Overactive Bladder

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

exercise women

Viveve Completes Enrollment in Short-Term Feasibility Study for Stress Urinary Incontinence

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

female doctor

New Research Takes P*** Out of Incontinence

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

imaging brain head

Incontinence in MS Affects Walking Ability, Negatively Impacts Patients’ Quality of Life, Study Finds

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

product approval introduction

Atlantic Therapeutics Announces FDA Clearance for Over-the-Counter Use of INNOVO®

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

product approval introduction

Contura Nabs FDA Nod for Female Incontinence Device

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

product approval introduction

InterStim Micro Neurostimulator and SureScan MRI Leads Cleared in Europe for Incontinence Control

Medtronic won EU regulatory clearance to introduce its InterStim Micro neurostimulator and InterStim SureScan MRI leads. The devices are used to deliver sacral neuromodulation therapy to treat overactive bladder (OAB), fecal incontinence, and non-obstructive urinary retention.  The InterStim Micro is a much tinier version of Medtronic’s InterStim II neuromodulator, as it is 80% smaller, but it is a rechargeable device with an expected longevity of about 15 years. This is made possible partially thanks to so-called Overdrive technology that lets the battery maintain almost its full capacity to recharge throughout its working life. Read more.

Source: Medgadget, January 13, 2020