Amber Therapeutics Announces Successful First-in-human Implants of Amber-UI: An Intelligent, Closed-loop Bioelectrical Therapy for Urge and Mixed Urinary Incontinence

Amber Therapeutics (‘Amber’ or the ‘Company’), a University of Oxford spinout developing next-generation, intelligent bioelectrical therapies to transform clinical outcomes in patients with functional disorders of the peripheral nervous system, announces that the first participants have been implanted with Amber-UI, the Company’s proprietary therapy for urge and mixed urinary incontinence (UI). Amber-UI is the first fully implantable closed-loop bioelectrical therapy in clinical development for UI, which is made possible by being able to access and target the pudendal nerve – the nerve that directly controls continence – through a novel, minimally invasive surgical procedure. Read more.

Source: PRNewswire, January 24, 2023

Prasterone Shows Promise In Reducing Severity of Urinary Urge Incontinence

Because of a decrease in estrogen, menopause is often accompanied by multiple vaginal and urinary issues. To date, most treatment options focus on vulvar and vaginal atrophy, with fewer options available to treat urinary incontinence. A new study, however, suggests prasterone is effective in improving the severity of urinary urge incontinence. Study results are published online today in Menopause, the journal of The North American Menopause Society (NAMS). Read more.

Source: Newswise, July 27, 2022

Valencia Technologies Announces FDA Approval of eCoin® Therapy to Treat Urinary Urge Incontinence

Valencia Technologies Corporation, a privately held company, today announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of its eCoin^® leadless tibial neurostimulator for the treatment of urinary urge incontinence (UUI), which affects over 60% of patients who suffer from Overactive Bladder (OAB). FDA approval was supported by the efficacy and favorable safety profile demonstrated in the eCoin^® pivotal trial. The company also announced the publication of these results in the Journal of Urology^®, the official journal of the American Urological Association. Read more.

Source: PRNewswire, March 2, 2022

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

Axonics® Announces U.S. Food & Drug Administration Approval for its Sacral Neuromodulation System for Urinary Clinical Indications

Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing novel implantable rechargeable sacral neuromodulation (“SNM”) devices for the treatment of bladder and bowel dysfunction, today announced the approval of the Axonics r-SNM® System by the United States Food & Drug Administration (“FDA”) for the clinical indications of overactive bladder (“OAB”) and urinary retention. The FDA premarket approval (“PMA”) grants Axonics the right to market its product in the United States for the clinical indications of OAB (urinary urge incontinence and urinary urge frequency) as well as urinary retention, representing the largest segment of the market for SNM devices. The FDA approval follows the Company’s September approval for the clinical indication of fecal incontinence, which, according to published clinical studies, is a co-morbidity reported by as many as a third of patients presenting with urinary urge incontinence. Read more.

Source: Business Wire, November 14 2019

CVD Factors, Especially High Blood Pressure, May Increase Risk of Severe Urge Incontinence

Patients with cardiovascular risk factors are more likely to also experience urgency urinary incontinence (UUI), according to UK researchers. They also said their study findings indicated that severe urgency UUI was a “distinct disease” from milder forms of the condition.The researchers, from University College London and King’s College London, looked at data on 1,762 participants in a Medical Research Council survey who reported having incontinence at the age of 68. The prevalence of urinary incontinence was 15% in men and 54% in women. UUI was the most common subtype in men, while there were similar proportions of UUI and stress urinary incontinence in women, with it being reported by 12% of men and 19% of women. Read more.

Source: Nursing Times online, March 9, 2018

Sleep Quality Improves with Help of Incontinence Drug

A drug used to curtail episodes of urinary incontinence in women also improves quality of sleep, a researcher at the Stanford University School of Medicine reports. People who experience urinary incontinence, especially at night, often have trouble maintaining normal sleep cycles. Now, the Stanford researcher sees promise in using one drug to help remedy both problems. “Two of the biggest quality-of-life factors for older women are poor sleep quality and incontinence, and the older you get, the more prevalent both conditions are, and they do seem to be correlated,” said Leslee Subak, MD, professor and chair of obstetrics and gynecology. “And so, if we can find a drug to treat one and effectively decrease the other too, that could be big for improving quality of life.” Read more.

Source: Stanford Medicine News Center, January 11, 2018

You may also with to read: Incontinence Drug May Help Sleep Dysfunction in Older Women

Astellas Submits Supplemental New Drug Application for Mirabegron

Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the use of mirabegron in combination with solifenacin succinate 5 mg for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. In the United States, mirabegron and solifenacin succinate are marketed as Myrbetriq^® and VESIcare^®, respectively. Each is approved by the FDA as a monotherapy for the treatment of OAB with symptoms of urge urinary continence, urgency and urinary frequency. Read more.

Source: PRNewswire, June 29, 2017

Identifying Overactive Bladder Syndrome

An interview with Dr Michael Kennelly, urologist and Medical Director for the Charlotte Continence Center at Carolinas Medical Center, conducted by April Cashin-Garbutt, MA (Cantab) What are the main symptoms of overactive bladder syndrome (OAB)? Symptoms of OAB include leakage, the strong sudden need to “go right away,” and going to the bathroom too often. Read more.

Source: News-Medical.Net, June 28, 2017

StimGuard Enrolls First Patient in Office-Based Chronic Tibial Nerve OAB Incontinence Stimulation Study Utilizing the World’s Smallest Wireless System

StimGuard, a privately-held, pre-commercial stage medical device company, today announced the initiation and the first patient enrollment in a clinical trial of the world’s first miniature implantable device for the treatment of urgency urinary incontinence resulting from refractory overactive bladder (OAB) syndrome. The StimGuard device utilizes wireless technology and is placed through an introducer device the size of a needle at the tibial nerve to activate the afferent micturition (neural urinary) pathways. The clinical trial of this novel approach will launch this winter. Read more.

Source: Business Wire, December 15, 2016