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

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

How OnabotulinumtoxinA “Revolutionized” Treatment of Urologic Conditions

Urology Times® is celebrating its 50th anniversary in 2022. To mark the occasion, we are highlighting 50 of the top innovations and developments that have transformed the field of urology over the past 50 years. In this installment, Melissa R. Kaufman, MD, PhD, FACS, discusses the significance of onabotulinumtoxinA treatment in patients with overactive bladder. Dr. Kaufman is a Professor of urology, Patricia and Rodes Hart Endowed Chair of Urologic Surgery, and Chief of Reconstructive Urology and Pelvic Health at Vanderbilt University Medical Center, Nashville, Tennessee. Read more.

Source: Urology Times, February 16, 2022

EvidenceNOW: Managing Urinary Incontinence

In February 2022, AHRQ launched the Improving Nonsurgical Treatment of Urinary Incontinence among Women in Primary Care (INTUIT-PC). The initiative builds on AHRQ’s EvidenceNOW Model of external support to help primary care practices implement patient-centered outcomes research (PCOR) on effective nonsurgical interventions for UI such as behavioral approaches, medications, and neuromodulation. The initiative will help close the gap between evidence and primary care practice in care for UI in women. Read more.

Source: U.S. Agency for Healthcare Research and Quality, February 2022

New Study Finds More Than 60% of Adult Women in the U.S. Experience Urinary Incontinence

Axonics, Inc., a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, today highlighted the publication of a new study that provides updated estimates of urinary incontinence (UI) prevalence in the U.S. The study, titled “Updated Prevalence of Urinary Incontinence in Women: 2015-2018 National Population-Based Survey Data,” was published in the peer-reviewed journal Female Pelvic Medicine & Reconstructive Surgery, the official journal of the American Urogynecologic Society (AUGS). Study authors at the University of Wisconsin School of Medicine and Public Health utilized publicly available data from the 2015-2018 National Health and Nutrition Examination Survey (NHANES) sample and included over 5,000 women who completed mobile examinations and computer-assisted personal interviews with standardized UI questions. Read more.

Source: Business Wire, January 25, 2022