Latest Research, Industry, Medical and Scientific News
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
Axonics® Receives FDA Approval for Recharge-Free 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 (FDA) has approved its newly developed, long-lived, recharge-free sacral neuromodulation (SNM) implantable neurostimulator (INS). Read more.
Source: Business Wire, March 7, 2022
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
Tailoring Continence Management to Individual Needs in Residential Care
This observational study investigated the benefits of adopting a person-centred approach to the management of urinary incontinence and associated hygiene care. A trial was carried out in 12 residential care homes in the Emilia Romagna region of Italy. Toileting, containment product selection, frequency and timing of changes, and personal hygiene routines were tailored to the needs of individual residents. Skin redness improved, there was less leakage and residents’ wellbeing improved. Containment product changes were easier to carry out, fewer containment products were used, and product costs were reduced. The adoption of person-centred care initiatives was seen to benefit all stakeholders – namely, residents, caregivers and the administration of the residential care facility. Read more.
Source: Nursing Times, March 7, 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
Medtronic Receives FDA Approval for InterStim X™ System
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