Incontinence and Shame

“At the height of laughter, the universe is flung into a kaleidoscope of new possibilities.” – Jean Houston

Incontinence and Shame, Submitted by – Lianna

Introduction

I don’t remember the first time I felt shame for my incontinence, but I remember the last time. It was just over a year ago. I had been laughing at something a coworker said, though I can’t recall what it was that I thought was so funny. That’s when it happens, you see, only when the force of the humor is so strong that I am completely overtaken with gut-bursting laughter, doubled over, my body curving in on itself as if it were trying to hold on to something invisible, some last tether to solidity, while everything else in me isContinue reading

microbiologist at laboratory work

An Emerging Link Between the Urinary Microbiome and Urinary Incontinence

Most people know that microorganisms live on our skin, and in other places in the body such as the digestive tract. However, traditional thinking and medical teaching was that there was no such microbiome in the urinary tract. Many people may still believe that urine is sterile. Advanced detection methods such as enhanced urine cultures and DNA sequencing have shown that this is not true. Read more.

Source: Harvard Health Blog, August 12, 2020

product approval introduction

FDA Approves New Devices for Bladder and Bowel Control Conditions

The FDA has approved the InterStim Micro neurostimulator and InterStim SureScan MRI leads for the treatment of patients with bladder and bowl control conditions, according to Medtronic plc, the manufacturer of the devices.  InterStim Micro treats patients with overactive bladder, fecal incontinence, and non-obstructive urinary retention by delivering sacral neuromodulation (SNM) therapy. SNM sends “electrical impulses to the sacral nerves located in the lower back to improve bladder and bowel control. Read more.

Source: Urology Times, August 6, 2020

clinical medical

Viveve Announces FDA Approval to Conduct PURSUIT Trial for Improvement of Stress Urinary Incontinence

Viveve, Inc. (NASDAQ:VIVE), a medical technology company focused on women’s intimate health, announced today that the Company has received approval of its Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin a stress urinary incontinence (SUI) multicenter, randomized, double-blinded, sham-controlled clinical trial entitled PURSUIT – Prospective U.S. Radiofrequency SUI Trial. The trial is designed to evaluate the safety and efficacy of Viveve’s Cryogen-cooled Monopolar Radiofrequency (CMRF) treatment versus an inert sham tip for the improvement of SUI in women. Read more.

Source: BioSpace, July 7, 2020

product approval introduction

Rigicon Launches Two New Artificial Urinary Sphincter Systems for Incontinence Treatment

Rigicon announces that ContiClassic® Artificial Urinary Sphincter and the ContiReflex® Artificial Urinary Sphincter models have recently received CE Mark Approval and is initially available in all major European markets.  ContiClassic® Artificial Urinary Sphincter and ContiReflex® Artificial Urinary Sphincter are implant devices that treat Urinary Incontinence (UI). Conti® Artificial Urinary Sphincter Systems are indicated to treat urinary incontinence due to intrinsic sphincter deficiency in cases such as incontinence following prostate surgery. Conti® Artificial Urinary Sphincter Systems are designed to restore the function of the normal (healthy) urinary sphincter that restricts urine flow out of the bladder. Read more.

Source: PRWeb, May 7, 2020

computer typing contact us

ProvenMed Launches Online Store for Easy and Private Access to Its Innovative Incontinence Devices

UAE-based medical devices company ProvenMed Global FZ-LLC announced today that its online store, shop.provenmed.com, is now open for business. The company is also offering a limited time-only discount up to 40% on all products purchased via the online store.  ProvenMed specializes in urinary continence innovation and is renowned for their flagship suite of products called ActivGo®. It was the world’s first reusable and washing system-integrated urinary external catheter for male incontinence management. Read more.

Source: ProvenMed, April 12,2020

business buildings

StimGuard Announces Corporate Name Change to Micron Medical and Appointment of CEO as part of Expansive Executive Management Team

StimGuard LLC, a privately-held medical device company engaged in the development, manufacture and pre-commercialization of innovative wireless, injectable electroceutical device solutions for urological conditions, today announced that it is changing its corporate name to Micron Medical Corporation. In addition, effective immediately, Stephen Deitsch has been appointed as Chief Executive Officer (CEO) and will join the Company’s board of directors. Co-founder Laura Tyler Perryman will now assume the role of Chief Operating Officer (COO) in order to focus on product development, regulatory and clinical affairs efforts.  Read more.

Source: StreetInsider, April 3, 2020

business buildings

Essity Acquires Smart Ultrasound Technology for Incontinence Care

Hygiene and health company Essity is strengthening its offering in incontinence products through the acquisition of the Dutch company Novioscan. The company develops a wearable ultrasound technology that monitors the bladder and enables continence control. The purchase price is approximately SEK 70m (EUR 6.5m) on a debt-free basis.  The SENS-U innovation is a wearable ultrasound sensor that measures the level in the bladder. It sends a discrete notification that allows the user to empty their bladder in time. A version of SENS-U for children is already available in the market and an adult version is under development. Read more.

Source: PRNewswire, April 1, 2020

drugs for overactive bladder (OAB)

Urovant Sciences Announces U.S. FDA Acceptance of New Drug Application for Vibegron for the Treatment of Overactive Bladder

Urovant Sciences (Nasdaq: UROV) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application (NDA) for once-daily 75 mg vibegron for the treatment of patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.  The NDA has been assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 26, 2020. In addition, the FDA has communicated that they are not currently planning to hold an Advisory Committee meeting to discuss the application. Read more.

Source: Businesswire, March 5, 2020

exercise women

Viveve Completes Enrollment in Short-Term Feasibility Study for Stress Urinary Incontinence

Viveve Medical, Inc. (VIVE), a medical technology company focused on women’s intimate health, announced today that it has completed enrollment in its three-arm, three-month feasibility study to compare Viveve’s Cryogen-cooled Monopolar Radiofrequency (CMRF) treatment and a cryogen-only sham treatment to an inert sham treatment for the improvement of stress urinary incontinence (SUI) in women. The Investigational Testing Application (ITA) study, approved by the Canadian Ministry of Health, was initiated in January 2020. Read more.

Source: Yahoo Finance!, March 4, 2020