Urinary incontinence

GRAMINEX®, L.L.C. Final Publication of a Peer Reviewed Clinical Trial with Graminex® Flower Pollen Extract Focusing on Women’s Urinary Incontinence in Current Urology.

Retrieved on: 
月曜日, 5月 13, 2024
Health, Consumer, Women, General Health, Clinical Trials, Pharmaceutical, Vitamins, Supplements, RCT, Urology, Woman, L.L.C, Urinary incontinence, Karger Publishers, CBO, Trial of the century, Menopause

is pleased to announce publication of a peer reviewed clinical study with Graminex® Flower Pollen Extract for women’s urinary incontinence and urinary health in Current Urology.

Key Points: 
  • is pleased to announce publication of a peer reviewed clinical study with Graminex® Flower Pollen Extract for women’s urinary incontinence and urinary health in Current Urology.
  • The study was conducted as a randomized, double-blind, placebo-controlled study to investigate the effectiveness of Graminex® Flower Pollen Extracts in 114 healthy women with urinary incontinence.
  • A full version is available at: Current Urology - Original Article
    “Many women experience urinary incontinence throughout their lives during postpartum, menopause, and the natural aging process.
  • There is limited natural support to help improve the symptoms of urinary incontinence currently on the market.

Sumitomo Pharma Announces FDA Acceptance of Supplemental New Drug Application for Vibegron in Men with Overactive Bladder Symptoms Receiving Pharmacological Therapy for Benign Prostatic Hyperplasia

Retrieved on: 
月曜日, 5月 13, 2024
New Drug Application, Patient, SMPA, Food, Vibegron, Shanda, Urine, FDA, Safety, PDUFA, OAB, Ageing, Week, Urinary incontinence, Overactive bladder, Urination, BPH, Nocturia, Pharmaceutical industry

MARLBOROUGH, Mass., May 13, 2024 /PRNewswire/ -- Sumitomo Pharma America, Inc. (SMPA), announced today the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for vibegron (GEMTESA®), a beta-3 adrenergic receptor (β3) agonist, dosed once-daily (75 mg), for the treatment of men with overactive bladder (OAB) symptoms receiving pharmacological therapy for benign prostatic hyperplasia (BPH). If approved, vibegron will be the first and only beta-3 agonist for the treatment of men with OAB symptoms receiving pharmacological therapy for BPH. The FDA has set a target action date in Q3 of FY2024, under the Prescription Drug User Fee Act (PDUFA).

Key Points: 
  • MARLBOROUGH, Mass., May 13, 2024 /PRNewswire/ -- Sumitomo Pharma America, Inc. (SMPA), announced today the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for vibegron (GEMTESA®), a beta-3 adrenergic receptor (β3) agonist, dosed once-daily (75 mg), for the treatment of men with overactive bladder (OAB) symptoms receiving pharmacological therapy for benign prostatic hyperplasia (BPH).
  • If approved, vibegron will be the first and only beta-3 agonist for the treatment of men with OAB symptoms receiving pharmacological therapy for BPH.
  • The FDA has set a target action date in Q3 of FY2024, under the Prescription Drug User Fee Act (PDUFA).
  • "We are pleased the FDA has recognized the strength of the Phase 3 data for vibegron in the URO-901-3005 study within our application.

Pelvital Appoints Dr. Wanda Filer To Its Board of Directors

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木曜日, 5月 9, 2024
Medtech, FDA, American Academy, Public, UI, Flyte, Urinary incontinence, Woman, Policy, Health, Chairperson, MD, FAAFP, Public policy, Science, Incontinence, Manager, MBA

EAGAN, Minn., May 9, 2024 /PRNewswire-PRWeb/ -- Pelvital, the women's health MedTech company on a mission to transform the standard of care for urinary incontinence, is pleased to announce the election of Wanda Filer, MD, MBA, FAAFP, to its Board of Directors as an independent director, effective April 29, 2024. Dr. Filer brings a wealth of leadership experience in clinical family medicine practice, health and public policy, and national advocacy for transformative care and underserved populations.

Key Points: 
  • Dr. Filer brings a wealth of leadership experience in clinical family medicine practice, health and public policy, and national advocacy for transformative care and underserved populations.
  • Dr. Filer shared her excitement about joining Pelvital's Board of Directors.
  • "We are thrilled to welcome Dr. Filer to Pelvital's Board of Directors," says Lydia Zeller, CEO and President of Pelvital.
  • Dr. Filer's appointment reflects Pelvital's devotion to assembling a diverse and accomplished Board of Directors to usher the company on an exciting phase of innovation, increased visibility, and market access expansion.

MemorialCare Cancer Institute Revolutionizes Prostate Cancer Treatment: Hot Water Potential Solution to Prostate Cancer

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火曜日, 5月 7, 2024
Radiation, Cancer, Prostate cancer, Urinary incontinence, Surgeon, American Cancer Society, Urology, Research, Water, Oncology, Erectile dysfunction, Disease, Nursing, Patient, Social, Quality of life, Medical imaging

LAGUNA HILLS, Calif., May 7, 2024 /PRNewswire/ -- MemorialCare Cancer Institute at Saddleback Medical Center is the only location in Orange County – and one of only two in California – to offer a new, innovative way to treat prostate cancer patients with water vapor. This study, VAPOR 2, utilizes a minimally invasive and nonsurgical procedure that employs water vapor to target and destroy the walls of the cancer cells while minimizing damage to the surrounding healthy prostate tissue.

Key Points: 
  • A clinical trial tests if hot water vapor can attack cancer cells, in new non-surgical approach to prostate cancer treatment
    LAGUNA HILLS, Calif., May 7, 2024 /PRNewswire/ -- MemorialCare Cancer Institute at Saddleback Medical Center is the only location in Orange County – and one of only two in California – to offer a new, innovative way to treat prostate cancer patients with water vapor.
  • As the second most common cancer in U.S. men, the American Cancer Society estimates one in eight American men will be diagnosed with prostate cancer during their lifetime.
  • Prostate cancer is a serious disease often treated with therapies that cause complications, such as urinary incontinence and erectile dysfunction.
  • "We believe clinical trials are the front line in winning the battle against cancer," says Elizabeth "Liz" Acord, vice president, clinical integration, MemorialCare Cancer Institute.

Bridging Healthcare Gaps: The Wonder Woman Collective Unveils a New Vision for Women's Health

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金曜日, 5月 3, 2024
PCOS, Health equity, Urinary incontinence, Wonder, Infertility, Health, McKinsey & Company, Partnership, Human, Research, Pelvic floor dysfunction, Pelvic floor, Grammatical mood, Hypothyroidism, IVF, Entrepreneurship, Mental health, Patient, Work, Mother, Diagnosis, Migraine, Menopause, Quality of life, Nursing

With a shared commitment to innovation and excellence, this is the start of a foundation where future companies can join and redefine the standard of care in women's health. "With this initiative, we forge a new path in healthcare - one where comprehensive care, innovation, and patient-centricity are not just ideals, but realities. This is where the future of women's health begins." said Elizabeth Burstein, Co-Founder and CEO of Neura Health. Tina Keshani, Founder and CEO of Seven Starling adds "Women deserve specialized and tailored healthcare solutions to address their unique needs -- and no one company can do it all. "

Key Points: 
  • Five leading women's health companies, Paloma Health, Neura Health, LEVY Health, Seven Starling and Origin, have joined forces to announce The Wonder Woman Collective.
  • This strategic partnership addresses critical gaps in women's healthcare, focusing on improving healthcare outcomes, promoting health equity, reducing costs, and enhancing women's health.
  • "Addressing the Women's Health Gap is not just an option but a critical necessity.
  • "Through The Wonder Woman Collective, we are unifying diagnostic expertise and specialized care, enhancing the patient's journey and offering timely, comprehensive solutions," said Caroline Mitterdorfer, Co-Founder and CEO of LEVY Health.

Implantable Tibial Nerve Stimulation added as Treatment Option within AUA/SUFU 2024 OAB Guideline

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木曜日, 5月 2, 2024
Leg, FDA, Physician, Society, Patient, Diagnosis, Urinary incontinence, American Urological Association, Health, OAB, Treatment, AUA, Fascia, SUFU, Guideline, Quality of life, PMA, Female, Nursing

The eCoin® ITNS device is the only fully implantable FDA PMA approved device for treating urge urinary incontinence (UUI), the primary symptom of OAB.

Key Points: 
  • The eCoin® ITNS device is the only fully implantable FDA PMA approved device for treating urge urinary incontinence (UUI), the primary symptom of OAB.
  • This highlights the significant need for evolutionary treatment options to address the growing burden of a largely underserved OAB population.
  • "Valencia Technologies is humbled and honored to have the opportunity to take a lead role in the implantable tibial nerve stimulation space."
  • The eCoin® device contains a primary-cell battery that once activated, automatically delivers intermittent stimulation to the tibial nerve to reduce UUI symptoms.

AUA/SUFU Guideline on the Treatment of Overactive Bladder Allows Access to ReviTM System Earlier in Treatment Journey

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月曜日, 4月 29, 2024
FDA, Commercial software, Society, Risk, Urinary incontinence, Food, De novo, American Urological Association, Paruresis, Pharmacotherapy, MMHC, Guideline, OAB, Deficit spending, Prescription, Patient, Neuromodulation, Physician, AUA, Ankle, Diagnosis, SUFU, Anticholinergic, Female

The revised guidelines are a major affirmation of the importance of Revi as a therapy for patients with UUI.

Key Points: 
  • The revised guidelines are a major affirmation of the importance of Revi as a therapy for patients with UUI.
  • First, the guidelines were updated to include iTNM as an acceptable minimally invasive therapy.
  • "We are delighted to witness the transformation of the new OAB treatment guideline by the AUA/SUFU.
  • This guideline represents a significant turning point in physicians' approach to OAB management," commented Dan Lemaitre, Chief Executive Officer of BlueWind Medical.

Affluent Medical : 2023 financial results and update on clinical activities under development.

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金曜日, 5月 3, 2024
Medtech, FDA, Risk, De novo, Death, Mitral regurgitation, Doctor of Philosophy, Wound healing, Mitral valve annuloplasty, Boston Scientific, Ticker, Wealth, Urinary incontinence, Woman, Christophe, Food, Neurostimulation, Myocardial infarction, Aix-en-Provence, DSM-IV codes, LCEA, Mitral valve, TAVI, Minerva, Certification, Heart, Quality assurance, System, Anatomy, Exercise, NYHA, Dry, Marketing, Clinical trial, American College, Development director, MD, Endocarditis, Medtronic, Patient, Tricuspid valve, Acquisition, Medical device

Affluent Medical : 2023 financial results and update on clinical activities under development.

Key Points: 
  • Affluent Medical : 2023 financial results and update on clinical activities under development.
  • Affluent Medical estimates that KaliosTM would avoid repeat surgery for 30-40% of patients within five years of their operation.
  • In September 2023, the Company presented interim data on 20 patients treated in five clinical centers in Europe after one year of implantation.
  • In July 2023, Affluent Medical announced the appointments of Christophe de Vregille as Chief Financial Officer and Benjamin Renault as Development Director.

Zydus launches Mirabegron Extended-Release Tablets in the US

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月曜日, 4月 22, 2024
Biotechnology, General Health, Pharmaceutical, Health, Zydus Lifesciences, USP, Patient, Overactive bladder, USFDA, Mirabegron, Urinary incontinence, OAB, Generic drug

Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) announces the launch of Mirabegron Extended-Release Tablets, 25 mg in the US market.

Key Points: 
  • Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) announces the launch of Mirabegron Extended-Release Tablets, 25 mg in the US market.
  • The company had earlier received final approval from the United States Food and Drug Administration (USFDA) to market Mirabegron Extended-Release Tablets USP 25 mg and 50 mg (USRLD: Myrbetriq® Extended-Release Tablets).
  • Zydus is among the first suppliers to launch the generic version of Mirabegron Extended-Release Tablets, USP 25 mg in the US market and is prepared to launch Mirabegron Extended-Release Tablets, 50mg imminently.
  • Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency.

Axena Health receives two additional positive insurance coverage decisions for Leva

Retrieved on: 
木曜日, 4月 11, 2024
Medical Devices, Women, FDA, Health Technology, Health Insurance, Biotechnology, Health, Consumer, Pharmaceutical, UI, Urinary incontinence, Woman, BCBS, Food, Cigna, The Institute, Leva, MD, Highmark, Life, Pelvic floor, Female, Pelvic organ prolapse, Privacy, Incontinence, Overactive bladder, Storey, MBA, FACOG, Food and Drug Administration, HCPCS, Nursing

Both positive coverage decisions became effective on April 1, 2024.

Key Points: 
  • Both positive coverage decisions became effective on April 1, 2024.
  • “Axena Health is focused on providing evidence-based solutions through both formal clinical trials with world-class academic institutions and published real-world evidence.
  • “Two more positive coverage decisions for the Leva System means more women can access effective, first-line treatment for UI.
  • Highmark BCBS and BCBS of ND have joined Cigna in demonstrating their clear commitment to women’s health.