women exercising

FDA Grants DeNovo Clearance to Atlantic Therapeutics for INNOVO® Therapy Device to Treat Stress Urinary Incontinence

Atlantic Therapeutics, a global manufacturer of innovative, garment-based pelvic floor muscle strengthening and nerve stimulation products, announced today (13.11.18) that the U.S. Food and Drug Administration (FDA) has granted a DeNovo clearance for its INNOVO® therapy device, an externally worn electrical muscle stimulator for the treatment of stress urinary incontinence in adult females. INNOVO® is the first transcutaneous electrical stimulation continence device to be cleared by the FDA, following results of two randomized controlled trials (RCTs) demonstrating it to be an effective and low-risk device for the treatment for stress urinary incontinence (SUI) in adult females.  Read more.

Source: Business Wire, November 13, 2018

hormones change as women age

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

doctor male discussion

Most Transient SUI After HoLEP Resolves Within 6 Weeks

Most men who experience transient stress urinary incontinence (SUI) following holmium laser enucleation of the prostate (HoLEP) recover full bladder control within the first 6 weeks after the procedure, according to study findings presented at the International Continence Society’s 2018 annual meeting.  In addition, the study identified prostate size larger than 100 g and catheter dependency prior to HoLEP, and longer operative time as risk factors for transient SUI.  A retrospective review of 515 patients who underwent HoLEP showed that 53 (10.3%) experienced transient SUI, Jenny Guo, BS, and colleagues at Sidney Kimmel Medical College at Thomas Jefferson University in Philadelphia, reported. Transient SUI resolved within the first 6 weeks post-operatively in 47 (88.6%) of these patients and within 6 week to 3 months in 6 patients (11.3%). Read more.

Source: Renal and Urology News, August 30, 2018

stress urinary incontinence Polypropylene vaginal mesh

Government Agrees to Temporarily Ban Vaginal Mesh Implants for Women with Urinary Incontinence

The [UK] government has accepted a recommendation to temporarily ban vaginal mesh implants for women with urinary incontinence.  The Independent Medicines and Medical Devices Safety Review concluded there must be an immediate pause in the use of surgical mesh to treat stress-urinary incontinence (SUI) – a condition where urine leaks out when the bladder is under pressure.  It comes after the National Institute for Health and Care Excellence (NICE) ruled last year against vaginal mesh as a treatment for pelvic organ collapse, but stated devices could still be used to treat SUI and to repair hernias in men or women. Read more.

Source: Independent, July 9, 2018

business buildings

LABORIE Medical Technologies and Cogentix Medical Announce Completion of Acquisition

LABORIE Medical Technologies (“LABORIE”) and Cogentix Medical, Inc. (NASDAQ: CGNT) (“Cogentix”) today announced the completion of the acquisition by LABORIE of Cogentix through LABORIE’S affiliate Camden Merger Sub, Inc. (“Merger Sub”), a wholly owned subsidiary of LM US Parent, Inc. (“Parent”). After the previously announced completion of the tender offer for all of the outstanding shares of Cogentix, LABORIE completed the second step merger under Delaware law, resulting in Cogentix becoming a wholly owned subsidiary of Parent. At the effective time of the merger, all shares of Cogentix common stock not purchased in the tender offer (excluding those shares for which holders properly exercised appraisal rights under Delaware law and those held by Cogentix) were converted into the right to receive US$3.85, net to the seller in cash without interest thereon and subject to any required withholding tax, which is the same price that was paid for shares of Cogentix common stock purchased in the tender offer. Cogentix common stock will no longer be listed on the Nasdaq Capital Market or any other securities exchange. Read more.

Source: The Virginian-Pilot, April 23, 2018

mother post pregnancy

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

drugs for overactive bladder (OAB)

GTx Announced New Data Demonstrating Enobosarm’s Potential to Treat Stress Urinary Incontinence at SUFU 2018

GTx, Inc. (Nasdaq:GTXI) today announced additional results from a Phase 2 proof-of-concept clinical trial of 3 mg enobosarm administered orally in postmenopausal women with stress urinary incontinence (SUI), including magnetic resonance imaging (MRI) results from patients’ pelvic floor muscle. New data in a subset of women also suggests a positive treatment effect of enobosarm for urge incontinence (UI) suggesting a possible treatment effect for women with mixed incontinence. Results from a pre-specified analysis of MRI data demonstrate a statistically significant increase in pelvic floor muscle thickness and urethral muscle diameter after enobosarm treatment. Treatment with enobosarm also reduced mean UI episodes by approximately 68 percent in patients who experienced UI as well as SUI, based on a post hoc analysis of a subset of women with both UI and SUI. These results were outlined during a podium presentation which took place at the Society of Urodynamics, Female Pelvic Medicine, & Urogenital Reconstruction (SUFU) 2018 Meeting on Saturday, March 3, 2018. The presentation included clinical data from all 18 patients completing 12 weeks of enobosarm treatment, which, as previously reported, demonstrated an 81 percent reduction in the number of mean stress leaks per day (the primary endpoint of the clinical trial), as well as additional data demonstrating duration of response following completion of treatment, including nine patients who have now reached seven months post-treatment. Read more.

Source: Business Wire, March 5, 2018

mother post pregnancy

More Than Just a Cosmetic Procedure — ‘Tummy Tuck’ Reduces Back Pain and Incontinence

In addition to restoring the pre-pregnancy shape of the abdomen, abdominoplasty (‘tummy tuck’) surgery with muscle repair can improve back pain and urinary incontinence after childbearing, reports a study in the March issue of Plastic and Reconstructive Surgery®, the official medical journal of the American Society of Plastic Surgeons (ASPS).  Although abdominoplasty is classified as a cosmetic procedure, it also improves two of the most common physical complaints experienced by women after labor and delivery. According to the new research “Abdominoplasty has a proven functional benefit as well as a cosmetic benefit,” comments lead author D. Alastair Taylor, FRACS, of The CAPS Clinic in Deakin, Australia. Read more.

Source: EurekAlert, February 28, 2018

surgeons perform pelvic organ prolapse surgery

Australia Bans Use of Vaginal Mesh Implants for Prolapse

An Australian watchdog has banned the use of controversial vaginal mesh implants for prolapse after a review found “the benefits do not outweigh the risks these products pose to patients”.  The Therapeutic Goods Administration has decided to remove the use of mesh products in the treatment of pelvic organ prolapse and single incision mini-slings which is used to treat urinary incontinence. This move follows the news that NICE, the health watchdog in the UK, will recommend that mesh should be banned as a routine treatment for prolapse, a condition when organs such as the vagina, uterus or bowel fall down or slip out of place. The draft guidance, seen by Sky News and due to be published next month, states that mesh implants for prolapse should now only be used for research purposes. It does not affect the use of mesh for incontinence which accounts for the majority of operations. Read more.

Source: Sky News, November 29, 2017

surgeons perform pelvic organ prolapse surgery

First Patient in Malaysia Successfully Treated with Urolastic™

Urogyn B.V. and Leader Biomedical announce the first patient treated in Malaysia with Urolastic™– an innovative Urinary Stress Incontinence product that is exclusively offered by Leader Biomedical in India and APAC.  We are excited to announce that we have successfully introduced Urolastic™ in Malaysia and treated a female patient suffering from severe Stress Urinary Incontinence (SUI). The patient suffered from the condition, as a result of birth deficiencies and was diagnosed with a short, yet very wide urethra. After previously undergoing a procedure using a bulking agent, the patient went down from using eight pads a day, to five pads a day. Treatment with Urolastic™ earlier this month by Dr. Warren Lo Hwa Loon at Pantai Hospital Kuala Lumpur has improved the patient’s condition, as a result of which she now only uses one pad a day, thus significantly improving her quality of life. Stress Urinary Incontinence is a disease affecting over 200 million people worldwide. Traditionally, SUI is treated with either a sling or injection of a bulking agent, where a sling procedure is an invasive procedure for the patient and the traditional bulking agents are expensive, as they are only effective for a short period and need to be repeated regularly. Read more.

Source: OpenPR, September 26, 2017