coffee

How Switching to Decaf Could Save NHS £85m a Year

In the first-of-its-kind trial, care home residents were offered decaffeinated hot drinks in a bid to reduce falls experienced rushing to the toilet.  Conducted across eight residential Stow Healthcare homes over six months, the simple switch resulted in a 35% reduction in toileting-related falls.  If scaled across the sector, the results, a study suggested, would mean thousands of falls prevented and NHS savings of up to £85 million per year.  This is according to a joint report published today by Care England, Stow Healthcare and University Hospitals of Leicester NHS Trust (UHL).  The trial followed a similar initiative by UHL in 2021. Noticing that many hospital patients were falling on the way to the toilet, Continence Nurse Specialist Sarah Coombes suggested switching to decaffeinated drinks to reduce bladder and bowel urgency in those with an overactive bladder or incontinence. Within three months, toileting-related falls in the hospital were down by 30%.  Read more.

Source: Care Home Professional, April 24, 2024

nurse and patient

Published Data Demonstrate Excellent Safety and Efficacy and Reinforce Patient Satisfaction with Revi™ System in the Treatment of Urge Urinary Incontinence

BlueWind Medical, Ltd., a pioneer in implantable Tibial NeuroModulation (iTNM) and the developer of ReviTM, a patient-centric solution for urge urinary incontinence (UUI), today announced that the peer-reviewed results from the OASIS pivotal trial were published in the Journal of Neurourology and Urodynamics (NAU). OASIS, a prospective, multicenter, single-arm, open-label clinical study of 151 women, was designed to demonstrate the safety and efficacy of Revi in reducing symptoms of overactive bladder (OAB).  The trial results demonstrate a statistically significant improvement with a 78.4% clinical success rate as defined by at least a 50% reduction in UUI at 12 months in the intention to treat (ITT) analysis (p<.0001). Read more.

Source: PRNewswire, April 23, 2024

Higher Rate of Bladder Neck Incompetence in Mixed Urinary Incontinence

Patients with mixed urinary incontinence (MUI) have a higher rate of bladder neck incompetence (BNI), according to a study published online Sept. 29 in the World Journal of Urology.  Yu-Chen Chen, from the Kaohsiung Medical University in Taiwan, and colleagues conducted a retrospective analysis involving 184 patients with stress UI (SUI), MUI, urge UI (UUI), or dry overactive bladder (OAB) who underwent transrectal ultrasound between 2017 and 2022. In all included patients, the presence of BNI and urethral incompetence was recorded. Read more.

Source: Medical Xpress, November 1, 2023

product approval introduction

BlueWind Medical’s Revi™ System Secures U.S. FDA De Novo Classification Grant for the Treatment of Urgency Incontinence

BlueWind Medical, Ltd. today announced that the US Food and Drug Administration (FDA) granted a De Novo marketing request for the Revi System, a transformative tibial neuromodulation therapy for the treatment of the symptoms of urgency incontinence alone or in combination with urinary urgency. Physicians should follow clinical guidelines as applicable and should use their discretion to determine if Revi can be used before patients fail or not tolerate more conservative therapy. The De Novo grant is for men and women with urge urinary incontinence (UUI) and was based on results from the OASIS pivotal trial, in which Revi demonstrated statistically significant improvement in the reduction of symptoms of UUI compared to baseline and a favorable safety profile. Read more.

Source: PRNewswire, August 17, 2023

meeting conference

Clinical Study Results of the BlueWind System for Patients with Overactive Bladder Featured at the 2023 AUA Annual Meeting

BlueWind Medical, Ltd., the developer of a transformative implantable tibial neuromodulation therapy for Overactive Bladder (OAB), today announced results from the OASIS pivotal trial evaluating the safety and efficacy of the BlueWind System in the treatment of OAB. The results were featured in the late-breaking session (LBA01-05) at the American Urological Association (AUA) 2023 Annual Meeting in Chicago on Sunday, April 30th. Read more.

Source: PRNewswire, May 1, 2023

business buildings

Avation Medical Announces US FDA 510(k) Clearance for The Vivally® System

Avation Medical, Inc., the innovator in patient-friendly, closed-loop neuromodulation options to treat life-altering medical conditions, today announced that its Vivally System received US Food and Drug Administration (FDA) 510(k) clearance. Vivally is a non-invasive, bladder control therapy device and mobile application to treat patients with the conditions of urinary urgency and urge urinary incontinence (UUI) caused by overactive bladder (OAB) syndrome, without the need for surgery, drugs, or needle-electrodes. The Vivally System is the only closed-loop, non-invasive neuromodulation system for bladder control cleared for sale in the United States. Closed-loop control objectively confirms activation of the tibial nerve and continuously adjusts therapy parameters to ensure optimal output throughout the session. Read more.

Source: PRNewswire, April 11, 2023

clinical medical

Neuspera Medical® Announces First Successful Implant of the Nuvella™ System in the Second Phase of Its SANS-UUI IDE Clinical Trial

Neuspera® Medical, a medical device company developing implantable devices for patients battling chronic illnesses, today announced the first patient successfully implanted with the Nuvella™ system in its pivotal clinical trial (SANS-UUI). The procedure was performed by Dr. Jodi Michaels of Minnesota Urology, St. Paul, MN. The study will evaluate the safety and efficacy of the Nuvella system, designed to treat overactive bladder (OAB) with sacral neuromodulation (SNM) in patients with urinary urgency incontinence (UUI) symptoms. Read more.

Source: PRNewsire, October 10, 2022

nurse and patient

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

tibial nerve

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

female doctor

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