Below you will find news and press releases from industry, government, and academia regarding product developments and medical/scientific research news.
Atlantic Therapeutics, a global manufacturer of innovative, garment-based pelvic floor muscle strengthening and nerve stimulation products, exhibits data highlighting comparable safety and efficacy of its INNOVO® therapy, an externally worn electrical muscle stimulation device for the treatment of stress urinary incontinence, with greatly reduced risk of infection and improved user tolerability over existing intravaginal probe devices1. Presented as a poster at the 48th Annual Meeting of the International Continence Society, the data was the result of an FDA designed clinical trial, with patients whose condition had not improved using pelvic floor muscle training. Supporting Atlantic Therapeutics’ FDA approval via the De Novo route for INNOVO®. Designed for at home use and worn as a close-fitting pair of shorts, INNOVO® was compared with an existing FDA approved intravaginal stimulation product as control. Read more.
Source: PRNewswire, August 28, 2018
TARIS, a biopharmaceutical company developing transformational therapies to treat people with debilitating urological disorders, today announced positive preliminary safety and efficacy data from its clinical study of TAR-302 for the treatment of patients with idiopathic overactive bladder (OAB) refractory to oral therapy. Subjects in the Phase 1b study received a single TAR-302 system, which provides continuous local dosing of the approved antimuscarinic agent trospium into the bladder. Subjects who were experiencing an average of more than five daily urge incontinence episodes demonstrated a reduction in mean daily episodes of 75% following dosing for 42 days (p=0.0049). Based on the unmet need in this disease state and the efficacy demonstrated in this study on established endpoints, TARIS plans to rapidly advance this program into later stage trials. “The results of this study suggest TAR-302 may come to represent an innovative new approach to treating overactive bladder,” said Michael J. Kennelly, M.D., FACS, Professor of Urology at Carolinas Medical Center, Medical Director of the Charlotte Continence Center and Women’s Center of Pelvic Heath, and Principal Investigator of the TAR-302 clinical studies. “There is a substantial need for alternative options in the management of OAB when patients fail oral therapies. The compelling efficacy observed to date with TAR-302, in the absence of side-effects, represents a potentially significant advance in the development of improved therapies for these patients.” Read more.
Source: PRNewswire, August 28, 2018
The 10 charities, including Alzheimer’s Society, Age UK, Marie Curie, warned that the taboo around the topic forces those affected to struggle in silence and more research is needed. As a result, the organisations held a workshop where common problems and solutions for incontinence issues were discussed by patients, carers, researchers and clinicians. Others involved include Parkinson’s UK, Guts UK, the Urology Foundation, Devices for Dignity, the National Institute for Health Research, and the James Lind Alliance. A report based on the meeting – titled My bladder and bowel own my life and published today – recommends tackling the stigma and funding research into the issue. Read more.
Source: Nursing Times, August 22, 2018
Patients with spinal cord injuries report that in addition to paralysis the lack of bladder control is one of the most troubling issues. At University of California Los Angeles, researchers have shown that they were able to restore significant bladder control to five men that suffered through spinal cord injuries years prior to treatment. The researchers used transcutaneous magnetic spinal cord stimulation as their technique, delivering pulses of focused magnetic fields to the site of the injuries. Similar technology was just cleared in the United States to treat obsessive compulsive disorder. Read more.
Source: Medgadget, August 22, 2018
Analysis of PeriCoach real-world data conducted by an independent biostatistician reveals significant improvements in pelvic floor strength in five weeks, and reduction in urine volume and leakage episodes in only three weeks. The post-approval, all-comers observational study, reviewed women using the version 3 PeriCoach system. PeriCoach version 3, released May 2017, comprises a state-of-the-art biofeedback system combined with a structured treatment programme. The market-leading features include real-time technique feedback to assist with proper pelvic floor muscle contraction, and force-sensors that measure the muscles that matter. During initial set-up, new users are invited to participate in a structured exercise regime and record urinary habits in the app-based bladder diary. The PeriCoach “8 Week Challenge” provides users with reminders to exercise a minimum of five sessions a week, enter information into the bladder diary three days a week, and respond to a quality of life survey at onset, four and eight weeks. Read more.
Source: PRNewswire, August 21, 2018
Recommendation on screening for urinary incontinence in women by the Women’s Preventive Services Initiative (WPSI), a national coalition of women’s health professional organizations and patient representatives. The WPSI’s recommendations are intended to guide clinical practice and coverage of services for the Health Resources and Services Administration and other stakeholders. The target audience for this recommendation includes all clinicians providing preventive health care for women, particularly in primary care settings. This recommendation applies to women of all ages, as well as adolescents. Read more.
Source: Annals of Internal Medicine, August 14, 2018
Urinary incontinence occurs in nearly 1 in 2 women aged 45 years and older, a new study suggests. The study examined survey results from 143,096 women at baseline (2006–2009) and 59,060 women who participated in a follow-up survey (2012–2015). The prevalence of urinary leakage reported in these surveys was 44% and 44.6%, respectively, Kristine Concepcion, MD, MPH, of Family Planning NSW Ashfield in New South Wales, Australia, and colleagues reported in Neurourology and Urodynamics. Read more.
Source: Renal and Urology News, August 2, 2018