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Viveve Announces Topline Results from Pivotal U.S. PURSUIT Trial for Treating Female Stress Urinary Incontinence

Viveve Medical, Inc. , a medical technology company focused on women’s health and the treatment of female stress urinary incontinence (SUI), today announced topline result from the U.S. Pivotal PURSUIT clinical trial. PURSUIT was a multicenter, randomized, double-blinded, sham-controlled U.S. study to evaluate the safety and efficacy of the Viveve treatment for SUI in women. The results were obtained by the company on Friday evening, January 13, 2023.  The PURSUIT study did not meet its primary endpoint of achieving a statistically significant higher proportion of patients who experienced greater than a 50% reduction in urine leakage compared to baseline on the standardized 1-hour Pad Weight Test at 12 months post-treatment in the active treatment group versus the sham control group. Read more.

Source: Accesswire, January 17, 2023

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UroMems Initiates First-in-Human Study of Its Smart Implant to Treat Stress Urinary Incontinence

UroMems, a global company developing breakthrough, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully completed the first-in-human implant of the UroActive™ System, the first smart automated artificial urinary sphincter (AUS) investigational device to treat SUI. This initial clinical study is a key milestone in the development of UroActive. Read more.

Source: PRNewswire, November 29, 2022

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Urolon, A New Treatment for Female Stress Urinary Incontinence, Launches in the UK

Stress Urinary Incontinence (SUI) is the most common type of urinary incontinence. According to estimations around 1 in 3 women will experience bladder leakage at some point in their life. SUI happens when the sphincter muscle that controls the urethra, the pelvic floor tissues and muscles that are used to keep the urethra closed, weakens. Urolon developed by Netherlands-based AQLANE Medical, is solving for this.  Urolon is a bioresorbable, non-permanent filler that is completely removed from your body over time. The treatment is minimally invasive, takes around 20 minutes and can be performed in a hospital or clinic. Three small injections into the urethral wall restore its closure. Read more.

Source: FemTech Insider, October 6, 2022

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

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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