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

Simpler Surgery May Work As Well As Standard For Women With Incontinence

For women with frequent urine leakage, a newer and simpler “sling” surgery works as well as the standard version, according to a new clinical trial. The study involved women with stress urinary incontinence, where movement that puts pressure on the abdomen — such as running, lifting, coughing or laughing — causes urine leakage. When the condition is severe, surgery may be recommended. Read more.

Source: UPI, April 1, 2022

Individual Pessaries For More Successful Treatment Of Stress Incontinence Through 3D Printing

Simply Standing up, doing sports, or just laughing, it’s extremely unpleasant whenever urine suddenly leaks uncontrollably. Colloquially referred to as a ‘weak bladder’, it’s known as Stress Urinary Incontinence in medical terms. Although about one in three women suffers from uncontrolled urine leakage, incontinence is still taboo. Initially merely a physical problem, it also quickly weighs on the soul. For fear of unpleasant situations, those affected often withdraw and avoid social activities with families and friends. 3D printed pessaries may relieve the burden. Read more.

Source: The Science Times, November 14, 2021

Axonics® Expands into Stress Urinary Incontinence with the Acquisition of Bulkamid®

Axonics Modulation Technologies, Inc. (Nasdaq: AXNX), a medical technology company that has developed and is commercializing novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, today announced that it has acquired privately-held Contura Ltd. and its flagship product, Bulkamid, a best-in-class urethral bulking agent for women with stress urinary incontinence (SUI). Read more.

Source: Business Wire, February 25, 2021

Atlantic Therapeutics Announces FDA Clearance for Over-the-Counter Use of INNOVO®

Atlantic Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted over-the-counter (OTC) clearance to INNOVO^®, a non-invasive, clinically proven and wearable device that treats the root cause of bladder weakness, known clinically as stress urinary incontinence (SUI). INNOVO^® was previously available in the U.S. by prescription, with more than 3.5 million safe and successful therapy sessions delivered worldwide. Read more.

Source: Yahoo! Finance, February 6, 2020

Elidah Announces the Launch of ELITONE® – A New Non-Invasive Treatment for Women’s Incontinence

Elidah, Inc (https://elitone.com/), a woman-owned medical device company, today announced the launch of ELITONE®, the first and only patented medical device providing non-invasive treatment for stress urinary incontinence in women. ELITONE is the first product of its kind launched under a newly created FDA product category for non-invasive incontinence therapy. Stress urinary incontinence is the loss of bladder control when activities such as exercising, coughing, laughing or sneezing increase the internal pressure placed on the abdominal cavity and pelvic floor muscles. Read more.

Source: PRNewswire, August 20, 2019

Tepha Initiates Clinical Evaluation of P4HB Regenerative Scaffold for Stress Urinary Incontinence

Tepha has announced the initiation of a pilot clinical evaluation of the Company’s P4HB regenerative polymer scaffold for the surgical treatment of stress urinary incontinence (SUI). The study was initiated in Cape Town, South Africa in partnership with the Pelvic Floor Foundation of South Africa(“PFFSA”) and the University of Cape Town. The first procedures were performed by co-principal investigators, Dr. Stephen Jeffery of the University of Cape Town and Professor Jan-Paul Roovers of the Academic Medical Center, Amsterdam, The Netherlands. The Cape Town SUI study represents the first clinical application of Tepha’s P4HB polymer technology in the field of urogynecology. Based in Lexington, MA, Tepha is the pioneer developer and exclusive supplier of the P4HB polymer for medical applications that include hernia repair, plastic surgery, tendon & ligament repair, and wound closure. Read more.

Source: Compelo, February 28, 2019

Renovia Launches “REDUCE” – a Multi-Center Randomized Controlled Trial to Study Next-Generation leva® Pelvic Digital Therapeutic System for Urinary Incontinence

Renovia Inc. (“Renovia”), a company dedicated to discovering and delivering first-line digital therapeutic and diagnostic devices for women with pelvic floor disorders, today announced it has launched a large, multi-center randomized controlled trial (RCT) to study the efficacy of a first-line non-surgical digital therapeutic for the treatment of stress-dominant urinary incontinence (UI). Pelvic floor muscle exercises (PFME), also known as Kegel exercises, are the widely accepted first-line conservative treatment for pelvic floor disorders including stress, urgency, and mixed UI within the urogynecology, urology and physical therapy communities. However, many women have trouble identifying and contracting the correct muscles when performing these exercises, and remembering to perform the exercises regularly can be challenging. Read more.

Source: Business Wire, November 12, 2018

Stress Incontinence – A Hidden Disease Finds Some Light

While many of us have seen the ads for Attends, the problem being treated, urinary stress incontinence in women, is rarely mentioned [1]; and that is odd for a problem that by some reports effects 25% of women over age 25. (The incidence of breast cancer is about 12%). A recent article in the American Journal of Obstetrics and Gynecology sheds light on this somewhat unmentioned disease. Urinary incontinence is the involuntary passing of urine, frequently associated with coughing, laughing or any activity that causes a person to bear down. It is a result of the loss of support for the bladder, rectum, and vagina – all the structures of the pelvis and is most often seen in women after childbirth. For all the beauty and miracles of birth, passing an eight-pound object through the vagina causes some wear and tear. But physicians know little about the natural history and progression of this loss of pelvic support (clinically termed prolapse). The study provides a better understanding of the course of the disease and some possible milestones. Read more.

Source: American Council on Science and Health, April 3, 2018

GTx Announces Positive Results from Enobosarm Phase 2 Clinical Trial

GTx, Inc. (Nasdaq: GTXI) today announced top-line clinical trial results demonstrating that a daily dose of enobosarm 3 mg (GTx-024) substantially improved stress urinary incontinence (SUI) in women, as well as related quality of life measurements. In this open-label clinical trial, all 17 patients completing 12 weeks of treatment saw a clinically significant reduction (50 percent or greater) in stress leaks per day, compared to baseline. Mean stress leaks decreased by 83 percent from baseline over 12 weeks, and the reductions in daily stress leaks following completion of treatment have been sustained as patients are being followed for up to 7 months post-treatment to assess the durability of treatment effect. No patient has relapsed to her baseline levels. These results were presented at the International Continence Society (ICS) Annual Meeting currently being held in Florence, Italy from September 12-15, 2017. Read more.

Source: Business Wire, September 13, 2017