The prescription leva Pelvic Health System (Renovia) is the first device to offer a digital therapeutic therapy for pelvic floor muscle training to improve symptoms of urinary incontinence and fecal incontinence. In study findings published in Obstetrics & Gynecology, leva achieved significantly greater urinary incontinence symptom improvement than a standard home pelvic floor muscle training program at 6 and 12 months. Read more.
Source: Contemporary OB/GYN.net, March 8, 2023
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
Zida has recently launched “The Zida Control Sock” to help individuals suffering from overactive bladder and incontinence reduce their symptoms. The Zida Control Sock is an FDA-cleared neuromodulation device that uses transcutaneous tibial nerve stimulation to treat overactive bladder and incontinence. Read more.
Source: Newsfile Corp., January 11, 2023
Weight-loss surgery can have many health benefits, and now a new study suggests that long-term relief from urinary incontinence is one of them. Urinary incontinence (UI) is a common problem, and obesity is among the risk factors for it: Extra pounds put more pressure on the bladder and the muscles supporting it, which can cause urine to leak. Read more.
Source: UPI, December 14, 2022
UroMems, a global company developing breakthrough, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully completed the first-in-human implant of the UroActive™ System, the first smart automated artificial urinary sphincter (AUS) investigational device to treat SUI. This initial clinical study is a key milestone in the development of UroActive. Read more.
Source: PRNewswire, November 29, 2022
People with incontinence who used the Yoga of Immortals mobile app had significant improvement in the frequency and severity of urine leaks in four weeks, a new study shows. The globally used app combines specific yogic postures in the Sanatan tradition with breathing exercises, sound therapy, and meditation. Read more
Source: Futurity, July 27, 2022
Ipsen (Euronext: IPN; ADR: IPSEY) today announced that Dysport® (abobotulinumtoxinA) has received positive opinion in Europe for the management of urinary incontinence (UI) in adults with neurogenic detrusor overactivity (NDO) due to spinal cord injury (SCI) (traumatic or non-traumatic) or multiple sclerosis (MS), who are regularly performing clean intermittent catheterization (CIC). This positive opinion for Dysport® now permits individual European country Health Authorities to grant national approvals, according to their country regulations. In addition, Ipsen is also currently in the process of obtaining approvals in other countries outside the European Union. Read more.
Source: Globe Newswire, June 9, 2022
Virtual Research Organisation (VRO) ObvioHealth may have completed the first ever fully virtual urogynaecology study, in the form of a medical device clinical trial of Renovia’s digital intravaginal device Leva for female stress urinary incontinence. Urinary incontinence is unintentional passing of urine, which affects one in four women, particularly 75% of women above the age 65 reporting urine leakage. Pelvic floor muscle training (PMFT), commonly known as Kegels, is the standard among noninvasive approaches for urinary incontinence. However, 75% of women perform the exercises incorrectly by engaging wrong muscle groups or following a wrong routine. Leva is designed to help users how to preform Kegels more effectively. Read more.
Source: Clinical Trials Arena, March 17, 2022
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
Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced it received approval from the U.S. Food and Drug Administration (FDA) for InterStim X™ ― the next generation of the InterStim™ portfolio’s recharge-free device – and it is available immediately. InterStim systems are the standard of care in advanced therapy options, and the most personalized system, to deliver sacral neuromodulation (SNM) therapy. Now the only SNM system backed by 90+ clinical studies, 1,000+ clinical articles, 350,000 patients treated and 25 years of experience, also offers patients a decade or more of treatment with either the new recharge-free InterStim X device, or the rechargeable InterStim™ Micro device. Both devices are used in the treatment of overactive bladder (OAB), chronic fecal incontinence (FI), and non-obstructive urinary retention. Read more.
Source: PRNewswire, February 22, 2022