UroMems Announces Results of First-Ever Smart Artificial Urinary Sphincter Implant in Female Patient to Treat Stress Urinary Incontinence

UroMems, a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully met the six-month primary endpoint for the first-ever female patient implanted with the UroActive™ System, the first smart automated artificial urinary sphincter (AUS) to treat SUI. This milestone indicates a new era for millions of women suffering from SUI, and signals an exciting transition for surgeons treating SUI not only in France, where the female patient was treated, but also across Europe and the U.S. Read more.

Source: PRNewswire, February 14, 2024

clinical medical

UroMems Reaches Significant Milestone: Successful Results in Clinical Feasibility Study of UroActive™ Smart Implant for Stress Urinary Incontinence Treatment

UroMems, a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today it has reached a significant milestone: the complete treatment cohort in the first-of-its-kind clinical feasibility study has successfully reached the six-month primary endpoints.  The feasibility assessment of the UroActive System was completed through a prospective multicenter clinical study. UroActive is the first smart automated artificial urinary sphincter (AUS) to treat SUI, and the only one to reach this critical milestone.  Read more.

Source: PRNewswire, December 13, 2023

drugs for overactive bladder (OAB)

Versameb AG Announces FDA Clearance of IND Application for VMB-100 in the Treatment of Stress Urinary Incontinence

Versameb AG (“Versameb”), a pre-clinical stage company focused on transforming RNA therapeutics to treat unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application of VMB-100, a potency enhanced messenger ribonucleic acid (mRNA) encoding human insulin-like growth factor-1 (IGF-1), for the treatment of stress urinary incontinence (SUI).  Following this clearance, Versameb plans to launch a Phase 2a open label, first-in-human dose ascending study in the first half of 2024. The study will evaluate the safety, tolerability, and efficacy of VMB-100 in female subjects with stress urinary incontinence, a highly common condition resulting in involuntary leakage of urine due to a weakened urinary sphincter muscle. Read more.

Source: Pharmaweb.com, November 17, 2023

Higher Rate of Bladder Neck Incompetence in Mixed Urinary Incontinence

Patients with mixed urinary incontinence (MUI) have a higher rate of bladder neck incompetence (BNI), according to a study published online Sept. 29 in the World Journal of Urology.  Yu-Chen Chen, from the Kaohsiung Medical University in Taiwan, and colleagues conducted a retrospective analysis involving 184 patients with stress UI (SUI), MUI, urge UI (UUI), or dry overactive bladder (OAB) who underwent transrectal ultrasound between 2017 and 2022. In all included patients, the presence of BNI and urethral incompetence was recorded. Read more.

Source: Medical Xpress, November 1, 2023

clinical medical

UroMems Announces Results of First Patient in Smart Implant Study to Treat Stress Urinary Incontinence

UroMems, a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully met the primary endpoints for the initial male patient in its SOPHIA study. SOPHIA is the first-in-man study of the UroActive™ System, the first smart automated artificial urinary sphincter (AUS) to treat SUI. The results of this clinical study will support design and implementation of UroMems’ pivotal clinical trial in Europe and the U.S. Read more

Source: PRNewswire, June 6, 2023

AUA, SUFU Release an Amendment to the Female Stress Urinary Incontinence Guideline

Today, the American Urological Association (AUA), in partnership with the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU), released the 2023 clinical practice guideline amendment for the surgical treatment of female stress urinary incontinence (SUI).  SUI is a common problem experienced by many women. About 1 in 3 women suffer from SUI at some point in their lives, and the chance of having urinary incontinence increases with age. The updated guideline has 24 recommendations that provide a clinical framework for the assessment and treatment of SUI in women. Read more and access the new guideline.

Source: PRNewswire, April 25, 2023

business buildings

UroMems Granted Safer Technologies Program Designation from FDA for Smart Implant to Treat Stress Urinary Incontinence

UroMems, a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that they have received Safer Technologies Program (STeP) designation from the U.S. Food and Drug Administration (FDA) for UroActive Smart Continence Therapy. STeP is a collaborative program intended to help reduce the time it takes to develop and obtain marketing authorization for eligible devices. Read more.

Source: PRNewswire, April 20, 2023

business buildings

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

operating room surgery

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

woman

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