Viveca Biomed Launches Contrelle To Create ‘Revolution’ In Tackling Stress Urinary Incontinence

Viveca Biomed has launched an innovative and clinically-proven bladder support device, Contrelle that offers women immediate relief from stress urinary incontinence (SUI) and provides community pharmacy contractors with a way to build a new consumer base, customer loyalty and sales margins. The product, named ‘Contrelle Activgard’, has already recorded millions of sales in Scandinavia over a decade. Read more.

Source: Pharmacy Business, August 24, 2022

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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

pelvic vaginal mesh stress urinary incontinence Polypropylene vaginal mesh

Newer Mesh Slings for Stress Incontinence a Safe, Effective Option for Women: Study

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: HealthDay News, March 31, 2022

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Renovia, ObvioHealth Conclude Fully Virtual Medical Device Trial in Urogynaecology

Virtual Research Organisation (VRO) ObvioHealth may have completed the first ever fully virtual urogynaecology study, in the form of a medical device clinical trial of Renovia’s digital intravaginal device Leva for female stress urinary incontinence.  Urinary incontinence is unintentional passing of urine, which affects one in four women, particularly 75% of women above the age 65 reporting urine leakage. Pelvic floor muscle training (PMFT), commonly known as Kegels, is the standard among noninvasive approaches for urinary incontinence. However, 75% of women perform the exercises incorrectly by engaging wrong muscle groups or following a wrong routine. Leva is designed to help users how to preform Kegels more effectively. Read more.

Source: Clinical Trials Arena, March 17, 2022

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Caldera Medical Announces FDA Clearance for New Desara® TVez for Stress Urinary Incontinence

Caldera Medical, a medical device company that develops best-in-class surgical products for the treatment of Stress Urinary Incontinence, Pelvic Organ Prolapse, and Polyps announced the launch of Desara® TVez, an expansion to their Desara® Family of products.  Caldera Medical, a medical device company that develops best-in-class surgical products for the treatment of Stress Urinary Incontinence, Pelvic Organ Prolapse, and Polyps announced the launch of Desara® TVez, an expansion to their Desara® Family of products. Read more.

Source: Business Wire, December 2, 2021

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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

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First Patients Enrolled in Uromedica’s Adjustable Continence Therapy (ACT®) for Female Stress Urinary Incontinence (SUI) Trial

Uromedica, Inc. announces the initiation of its FDA Investigational Device Exemption trial for ACT® to evaluate its safety and efficacy for treatment of female SUI.  Stress urinary incontinence is the accidental leakage of urine that can occur when sneezing, coughing, or performing physical activity. The investigational intent of the ACT trial, a post-operatively adjustable, minimally invasive outpatient procedure, is to assess safety and efficacy for women who suffer from moderate or severe SUI. Read more.

Source: Business Wire, March 10, 2021

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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

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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

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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