Recurring UTIs: The Infection We Keep Secretly Getting

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’s Revi™ System Secures U.S. FDA De Novo Classification Grant for the Treatment of Urgency Incontinence

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

Incontinence Management: A Crisis In Plain Sight

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

Vaginal Estrogen Effective Against Recurrent UTIs

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

Drug-coated Balloon Gets FDA Clearance for Treating Enlarged Prostate

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

New Muscle Therapy Gets Fast-Track Boost

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

AUA/SUFU Updates Guideline on Surgical Treatment of Female Stress Urinary Incontinence

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

TENA Launches Sensitive Care™ Pads with its SkinComfort Formula™

Today, Essity, a leading global hygiene and health products company and the maker of TENA incontinence and skin care products, announced the launch of Sensitive Care^TM Pads, the first ever bladder weakness pads enriched with its gentle SkinComfort Formula. TENA Sensitive Care Pads are now available in-store and online at retailers across the U.S. Seventy-seven percent of women with bladder weakness claim to experience skin irritation and discomfort while wearing incontinence protection.¹ That’s why TENA is addressing intimate skin health with its SkinComfort Formula which incorporates TENA’s skin friendly layer in combination with soft and 100% breathable materials, to help protect intimate skin. Read more.

Source: PRNewswire, June 13, 2023

High Dry Night Rate for Users of New Bedwetting AI Alarm

High compliance users of the new bedwetting alarm, GOGOband, which utilizes real-time heart rate variability analysis and applies artificial intelligence (AI) to create an alarm to wake the user, have a 93 percent dry night rate, according to a study published online April 28 in the Journal of Pediatric Urology. Israel Franco, M.D., from the Yale University School of Medicine in New Haven, Connecticut, and Jon Coble, from GoGoband Inc. in Richmond, Virginia, evaluated a new bedwetting alarm, GOGOband, and assessed the efficacy in the first 18 months of use. All 54 individuals (mean age, 10.1 years) who used the system for more than 30 nights from Jan. 1, 2020, to June 2021, were included. Read more.

Source: Health Day, May 30, 2023

Axena Health Begins First-of-Its-Kind Global Study of Female Incontinence

Axena Health, Inc. (Axena Health), a women’s health medical device company focused on scalable treatments for female pelvic health, announced today a large-scale study that will investigate the burdens of incontinence on women in low- and middle-income countries to support equitable access to treatment. The first-of-its-kind study will examine how women could access treatment within local healthcare delivery systems and in a manner that accommodates cultural norms. Study results will be available in late 2023 and will inform the development of new treatment options based on the Leva^® Pelvic Health System, a digital health treatment for urinary incontinence (UI) with published studies supporting its effectiveness, including durable, long-term symptom relief. Read more.

Source: Yahoo! Finance, May 19, 2023