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Coloplast Launches Male Catheter Designed to Reduce the Risk of Urinary Tract Infections

The new intermittent catheter Luja™ addresses important risk factors for urinary tract infections, a significant burden for people using intermittent catheters as well as healthcare systems as a whole. Urinary tract infections represent a significant challenge for people who use intermittent catheters to empty their bladder. This includes people living with spinal cord injury, multiple sclerosis, or spina bifida. On average, intermittent catheter users have 2-3 urinary tract infections per year, which can lead to serious health complications, have a significant impact on quality of life, and result in hospitalisation, thereby putting pressure on local healthcare systems.  Read more.

Source: Yahoo News, February 2, 2023

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Axonics Receives FDA Approval for Fourth-Generation Rechargeable Sacral Neuromodulation System

Axonics, Inc. (Nasdaq: AXNX), a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, today announced that the U.S. Food and Drug Administration has approved the company’s fourth-generation rechargeable sacral neuromodulation system. The newly approved Axonics R20 neurostimulator is labeled for a functional life in the body of at least 20 years and reduces how frequently a patient needs to recharge their implanted device to just once every 6 to 10 months for only one hour.  Read more.

Source: BusinessWire, January 31, 2023

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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

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Incontinence Due to Pelvic Floor Issues Affects Women With DM1

Pelvic floor disorders, including urinary and anal incontinence, are common in women with myotonic dystrophy type 1 (DM1) and a cause of significant distress, according to a recent study in Canada.  “This study highlights the importance of screening these symptoms in a clinical setting and will help develop interventions to adequately treat these symptoms, taking into account the characteristics of the disease,” its researchers wrote. Ways of addressing urinary incontinence — reported by 60% of the women in this study — “should be explored due to the high prevalence of this disorder,” the team added. The study, “Prevalence of urinary incontinence and other pelvic floor disorders in women with myotonic dystrophy type 1,” was published in the journal Neuromuscular Disorders.  Read more.

Source: Bionews, January 17, 2023

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Viveve Announces Topline Results from Pivotal U.S. PURSUIT Trial for Treating Female Stress Urinary Incontinence

Viveve Medical, Inc. , a medical technology company focused on women’s health and the treatment of female stress urinary incontinence (SUI), today announced topline result from the U.S. Pivotal PURSUIT clinical trial. PURSUIT was a multicenter, randomized, double-blinded, sham-controlled U.S. study to evaluate the safety and efficacy of the Viveve treatment for SUI in women. The results were obtained by the company on Friday evening, January 13, 2023.  The PURSUIT study did not meet its primary endpoint of achieving a statistically significant higher proportion of patients who experienced greater than a 50% reduction in urine leakage compared to baseline on the standardized 1-hour Pad Weight Test at 12 months post-treatment in the active treatment group versus the sham control group. Read more.

Source: Accesswire, January 17, 2023