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

pelvic vaginal mesh stress urinary incontinence Polypropylene vaginal mesh

Newer Mesh Slings for Stress Incontinence a Safe, Effective Option for Women: Study

For women with frequent urine leakage, a newer and simpler “sling” surgery works as well as the standard version, according to a new clinical trial.  The study involved women with stress urinary incontinence, where movement that puts pressure on the abdomen — such as running, lifting, coughing or laughing — causes urine leakage. When the condition is severe, surgery may be recommended. Read more.

Source: HealthDay News, March 31, 2022

business buildings

Medtronic Kicks Off Pivotal Study of Tibial Neuromodulation Implant for Overactive Bladder

After receiving an FDA approval last month in bladder and bowel incontinence for its neuromodulation device implanted in the lower back, Medtronic isn’t resting on its laurels.  It has begun a clinical trial of a similar system placed near the ankle, which the company described as a more convenient option that may make the therapy available to more people. The medtech giant announced that its first patients have received implants in the pivotal study, with neurostimulators that tap into the posterior tibial nerve running up the back of the leg, to transmit electrical pulses that aim to help regulate an overactive bladder. Read more.

Source: Fierce Biotech, March 25, 2022

business buildings

Renovia, ObvioHealth Conclude Fully Virtual Medical Device Trial in Urogynaecology

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

clinical medical

Urovant Sciences Announces Positive Topline Results of Phase 2a Trial of its Potential Novel Gene Therapy, URO-902

Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., today announced positive topline results from its Phase 2a, double-blind, placebo-controlled exploratory study of URO-902, an investigational, novel, locally injected gene therapy product (plasmid human cDNA encoding maxi-K channel), in patients with overactive bladder (OAB), who were not well managed by oral therapies. Read more.

Source: Pharmiweb.com, March 7, 2022

product approval introduction

FDA Authorizes Study Exploring Novel Device for Bladder Incontinence

The FDA has approved the launch of an investigational device exemption trial exploring a novel implantable tibial neuromodulation (TNM) device designed to relieve symptoms of bladder incontinence.  The trial, known as the TITAN 1 Feasibility Study, is a multicenter, prospective trial aiming to enroll 20 patients at 8 clinical sites in the United States. The patients will have the device implanted in the posterior tibial nerve near the ankle. They will be followed for 12 months to assess the feasibility of the product. Enrollment for the trial is expected to commence in May. Medtronic currently offers several products for bladder control, including the InterStim sacral neuromodulation systems and the NURO percutaneous tibial neuromodulation (PTNM). Read more.

Source: Urology Times, April 27, 2021

exercise women

First Patients Enrolled in Uromedica’s Adjustable Continence Therapy (ACT®) for Female Stress Urinary Incontinence (SUI) Trial

Uromedica, Inc. announces the initiation of its FDA Investigational Device Exemption trial for ACT® to evaluate its safety and efficacy for treatment of female SUI.  Stress urinary incontinence is the accidental leakage of urine that can occur when sneezing, coughing, or performing physical activity. The investigational intent of the ACT trial, a post-operatively adjustable, minimally invasive outpatient procedure, is to assess safety and efficacy for women who suffer from moderate or severe SUI. Read more.

Source: Business Wire, March 10, 2021

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

drugs for overactive bladder (OAB)

First Big Test Approaches for Urovant

Investors who backed Urovant’s $140m flotation last September will soon find out whether the money was well spent. Before the end of March the company will release topline pivotal data on the overactive bladder project vibegron, a β3-adrenergic receptor agonist licensed from Merck & Co, and a positive result should allow regulatory filings to follow.  It seems likely that the trial will hit: Merck successfully conducted a large phase IIb study of vibegron a few years ago, and a similar compound is already on the market in the shape of Myrbetriq, which has been sold by Astellas since 2011. This well-established product has only four years of US patent life left, so if Urovant has any chance of building vibegron into a similarly large product it needs to prove that its contender is both safer and more effective.   Read more.

Source: Evaluate, March 12, 2019