Below you will find news and press releases from industry, government, and academia regarding product developments and medical/scientific research news.
Want to pee all the time, or been told to drink cranberry juice because it burns when you pee? If so, you might have experience with urinary tract infections or UTIs. UTIs happen when certain types of bacteria get into part of your urinary tract, like your bladder, and create an infection. Researchers estimate that 60% of women and 10% of men will get a UTI in their lifetime. Typically, people are told to avoid UTIs by bettering their personal hygiene—peeing before and after sex, wiping properly, ceasing douching—and drinking more water. Because of this, many people may feel ashamed or embarrassed when they get a UTI, thinking it was their fault. But about one in four women experience recurring UTIs, which is defined as having at least two infections in six months or three in a year. Even when these patients do everything right, they still get infections. Read more.
Source: NPR, September 6, 2023
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
I find often when trying to help providers improve their quality and operational performance metrics, most of the time they are overlooking or ignoring a major foundational concept. Two-thirds of the clinical pathways or critical elements that CMS has sent forth often involve the incontinence ecosystem (See Figure 1). Incontinence, as stated in some of my previous articles, needs to be taken seriously when trying to improve overall quality. Read more.
Source: McKnight’s Long Term Care News, August 9, 2023
According to a recent study published in the American Journal of Obstetrics & Gynecology, vaginal estrogen is effective in preventing recurrent urinary tract infections (UTIs) in women with hypoestrogenism. Over 60% of women are impacted by UTIs in their lives, costing over $2 billion per year in the United States. Breakthrough infections even while on active antibiotic suppression are reported in 70% to 80% of recurrent UTI cases. Read more.
Source: Contemporary OB/GYN, August 10, 2023
Benign prostatic hyperplasia — or BPH, more commonly known as an enlarged prostate — is common among older men. As many as 30% of those aged 80 or more years have severe enough symptoms — including urinary incontinence — to require treatment. One nonsurgical solution, balloon dilation, can be used to widen the urinary tract and has been around for several decades, but an innovative version of this tool recently received federal clearance and now is being used commercially. Read more.
Source: McKnight’s Senior Living, August 7, 2023
To help bring therapies for rare muscle diseases in children to market sooner, the Berlin-based start-up MyoPax, a spin-off from the Max Delbrück Center and Charité – Universitätsmedizin Berlin, has now received a boost from the U.S. Food and Drug Administration (FDA). The company has been granted the FDA’s orphan drug designation (ODD) and rare pediatric disease designation (RPDD), both of which offer multiple regulatory and financial advantages – including fast-track approval status and, eventually, market exclusivity. Read more.
Source: Eurekalert, July 26, 2023
The American Urological Association (AUA) and the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) has updated their 2017 clinical practice guideline on the surgical treatment of female stress urinary incontinence (SUI). This amendment is based on their review of 24 studies published through February 2022. No changes were made to the patient evaluation and cystoscopy and urodynamics testing sections and only a minor update was made to patient counseling. Read more.
Source: Renal and Urology News, June 16, 2023