product approval introduction

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

nursing home patients

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

Bacteria

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

children pediatric classroom

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

New Survey from Aeroflow Urology Reveals Over 70% of Consumers Struggle to Afford Diapers for Adults and Children

Aeroflow Urology, a nationwide provider of continence care supplies through insurance, announced today the results of a proprietary survey that demonstrates the divide in affordability for diapers and other incontinence products for low-income families in the United States. While legislation has been slowly passing in some states to improve access to diapers by removing taxation and other barriers, many Americans still struggle daily to afford these essential items for both children and adults. To gain a better understanding of the current gaps in affordability around diapers and the repercussions for those who cannot access these items, Aeroflow Urology conducted a third-party administered survey in April 2023 that polled more than 1,200 Americans with a single household income of $25,000 or double household income of $50,000 or less who care for someone needing diapers or incontinence supplies (i.e. kids, children and adults with disabilities, elderly, etc.). Read more.

Source: PRNewswire, July 11, 2023

mother post pregnancy

Missed Opportunities For the One In Five With Anal Incontinence After Childbirth

Researchers are calling for improved care and more awareness of injuries that leave over one in five of those giving birth with anal incontinence. Over one in five women will develop anal incontinence in the first five years after having a vaginal birth. Anal incontinence is common and usually caused by trauma to the pelvic floor, nerve damage and anal sphincter injuries. The timing of symptom onset varies; some women experience anal incontinence onset soon after childbirth (which may or may not resolve), while many develop worsening or new symptoms during the menopause. The University of Warwick-led study, with input from the MASIC Foundation (a national charity to support women who have suffered severe injuries during childbirth), identified missed opportunities in getting a diagnosis of anal incontinence, an absence of clear pathways for those who are referred for treatment, and a lack of awareness of the problem among health care professionals and those who have given birth. Read more.

Source: MedicalXpress, June 28, 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 logo Essity

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 CareTM 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

drugs for overactive bladder (OAB)

Black Patients Less Likely to Fill Prescriptions For Newer, Safer Urinary Incontinence Drugs

Millions of adults take medications to help relieve symptoms of overactive bladder and reduce episodes of urinary incontinence.  But research linking some of those medications called anticholinergic drugs, such as oxybutynin, to memory loss drove recommendations to treat urinary incontinence with beta-3 agonists, drugs that offer the same benefit but without the risk of cognitive decline.  A new study in JAMA Network Open led by Northwestern Medicine and Duke University School of Medicine shows Black patients are less likely to fill prescriptions for newer, safer urinary incontinence drugs compared to white patients, potentially raising their risk for dementia.  Read more.

Source: Duke University School of Medicine, June 12, 2023