Urinary Incontinence, Urge

TUESDAY, Sept. 3, 2024 -- Four weeks of low-frequency repeated transcranial magnetic stimulation (rTMS) positively impacts poststroke urinary incontinence, according to a study published online Aug. 8 in Scientific Reports . Jialu Chen, from the Second Affiliated Hospital of Chongqing Medical University in China, and colleagues investigated the therapeutic effect of low-frequency rTMS on the contralesional primary motor cortex (M1) in 100 patients with poststroke urinary incontinence. The analysis included patients randomly assigned to the rTMS group or a sham-rTMS group. The researchers found that after four weeks of intervention, the maximum cystometric capacity, maximum detrusor pressure, residual urine output, overactive bladder score (including frequency, urgency, and urgency urinary incontinence), and the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form improved significantly in the rTMS group versus the sham-rTMS group. No changes in pelvic floor muscle electromyography were detected in patients in either group. "Future clinical experiments aimed at determining the effectiveness of rTMS for poststroke urinary incontinence patients should be based on the timing and degree of damage, which could result in more effective rTMS programs," the authors write. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical study data to evaluate the safety and efficacy of the Neuspera System for the treatment of urinary urge incontinence (UUI) will support the FDA submission for regulatory approval SAN JOSE, Calif., July 23, 2024 /PRNewswire/ -- Neuspera Medical, Inc., a neuromodulation company pioneering the Neuspera Implantable Sacral Neuromodulation (SNM) System, announced it has reached a significant milestone: All implanted patients have completed the 6-month primary endpoint visit in the SANS-UUI pivotal trial of the Neuspera System. The Neuspera System is a discreet, minimally invasive, ultra-miniaturized implant designed to provide patients personal control and relief from urinary urge incontinence (UUI), a symptom of overactive bladder (OAB). The clinical data will support the U.S. Food and Drug Administration (FDA) submission for regulatory approval of the Neuspera System to treat OAB symptoms. "We're grateful to every physician and patient who participated in the clinical trial, and we're excited that our uniquely differentiated technology will help millions of patients when it is FDA-approved for treatment of OAB symptoms," said Steffen Hovard, CEO of Neuspera Medical. "The fact that the market is only 5% penetrated at this time is a clear indication that patients are looking for something different than what's available today. The Neuspera System delivers true innovation." OAB is a common medical disorder affecting roughly one in six adults. OAB symptoms include a sudden, uncontrolled need or urge to urinate, urine leakage, and/or the need to pass urine many times during the night and day. These symptoms can make it difficult to work, socialize, exercise and lead a normal, active life which can lead to depression, self-esteem and social stigma issues. This milestone comes on the heels of the American Urological Association (AUA) and Society for Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction's (SUFU) recently published 2024 Guideline on the Diagnosis and Treatment of Idiopathic Overactive Bladder. The guideline promotes a shared decision-making process between the patient and physician that weighs the patient's comorbidities along with expressed values, preferences, and treatment goals in order to help them make an informed decision regarding treatment. This new guideline will facilitate OAB patient access to the therapy that best meets their particular needs and goals without requiring a lengthy stepwise approach through multiple levels of therapy. SNM is recognized as the "gold standard" neuromodulation therapy for OAB. With a dramatically smaller implant and incision size than anything else on the market, and efficacy comparable to the best SNM data[1], Neuspera is expected to benefit greatly from the new guideline's consultative approach providing accelerated patient access to minimally invasive therapies that were previously considered "third line." The SANS-UUI multi-center, single-arm clinical study was designed to demonstrate the safety and efficacy of the Neuspera System and gain FDA approval in the U.S. Patients were screened and implanted with the device at 26 centers across the U.S. and Europe. Patients who participated in the Phase One clinical trial – and who have been finding relief using the Neuspera System to successfully control their UUI symptoms for up to 3.5 years – have called the Neuspera System "life-changing," "the miracle," and "easy to do." "I love that there is no battery implant compared to traditional devices and that it's outside of my body and I'm in charge of it," said one patient who participated in the Phase One clinical trial. "It's improved my life so much that I tell everybody about it," another patient said. "Reaching the final patient's primary endpoint visit for the clinical trial is an important milestone in Neuspera's journey towards revolutionizing the way physicians utilize SNM therapy," said Dr. Steve Siegel, chief medical officer of Neuspera Medical. "This will be a great solution for patients who want a high degree of symptom control with the smallest implantable neurostimulator available, designed to empower patients and provide ultimate discreetness putting control of life-altering symptoms in patients' hands." "As the coordinating investigator for the SANS-UUI clinical trial, based on my experience with the Neuspera System and how patients are responding, I'm excited to soon be able to offer an OAB treatment option that truly gives patients control of their bladders in the least invasive way with the ability to self-administer their therapy when it's convenient for them, and nobody else can see or feel it," said Dr. Osvaldo Padron with Florida Urology Partners. The Neuspera System has FDA clearance for treating chronic pain of peripheral nerve origin and is currently an investigational device for treating UUI, a symptom associated with OAB. About Neuspera Medical Neuspera Medical, Inc. is committed to developing implantable medical devices that will improve the lives of patients battling chronic illnesses. The Neuspera platform is designed to provide patients and physicians with new, and potentially earlier, treatment options that are less invasive and more adaptable. These therapeutic alternatives aim to help patients restore their health and well-being for a better quality of life. For more information, please visit . The Neuspera System is the least invasive sacral neuromodulation device and includes an ultra-miniaturized pulse generator attached to an electrode array. It is designed to be discreet and fit within the protected space of the sacral foramen, so patients typically don't feel any lump or bulge and the tiny 4-5 mm scar from the implant procedure is usually barely perceptible, even if you know where to look. This design eliminates the need for more invasive tunneling and a separate pocket for an implanted battery, avoiding issues that negatively affect patient satisfaction with traditional SNM systems while empowering patients to regain control of their OAB symptoms and life. 1 Based on outcomes of the SANS-UUI Phase I clinical data; Padron et al. (2021). TREATMENT OF URINARY URGENCY INCONTINENCE (UUI) WITH AN ULTRA-MINIATURIZED SACRAL NERVE MODULATION (SNM) SYSTEM: PRELIMINARY OUTCOMES OF THE SANS-UUI STUDY. Journal of Urology. 2021 Sep 1;206(Supplement 3):e1158. Media Contact: Shelli Lissick Bellmont Partners 651-276-6922 [email protected] SOURCE Neuspera Medical, Inc.

Capital from Olympus Innovation Ventures, another strategic investor and several institutional investors will fund through expected PMA approval SAN JOSE, Calif., July 15, 2024 /PRNewswire/ -- Neuspera Medical, Inc., a neuromodulation company pioneering the Neuspera Implantable Sacral Neuromodulation (SNM) System, announced the closing of its Series D funding round raising $23 million and led by Vertex Ventures HC and Treo Ventures with participation by Action Potential Venture Capital, Windham Venture Partners, Olympus Innovation Ventures and another strategic investor. This round will fund the company though expected U.S. Food and Drug Association (FDA) premarket approval (PMA) of the Neuspera System, the discreet, minimally invasive, ultra-miniaturized implant designed to provide patients personal control and relief from urinary urge incontinence (UUI), a symptom of overactive bladder (OAB). "As a partner of choice for innovators in urology, we are thrilled to invest in the Neuspera team as they bring the Neuspera System through FDA approval and to the market," said Gabriela Kaynor, President of Olympus Innovation Ventures and Chief Strategy Officer at Olympus Corporation. "Based on critical unmet market need and patient demand, changes in society guidelines, and positive feedback from patients and physicians in clinical trials, we are excited to invest in the Neuspera team as they build their innovative Neuspera System for OAB." OAB is a common medical disorder affecting roughly one in six adults. OAB symptoms include a sudden, uncontrolled need or urge to urinate, urine leakage, and/or the need to pass urine many times during the night and day. These symptoms can make it difficult to work, socialize, exercise and lead a normal, active life which can lead to depression, self-esteem and social stigma issues.1 "We're excited to bring new partners on board as we approach the next significant milestone of submitting the Neuspera System for regulatory approval," said Steffen Hovard, CEO of Neuspera Medical. "The confidence and conviction of our new and existing investors, like Olympus Innovation Ventures, demonstrates the strength and potential of our platform technology." The Neuspera System is the least invasive sacral neuromodulation device and includes an ultra-miniaturized pulse generator attached to an electrode array. It is designed to be discreet and fit within the protected space of the sacral foramen, so patients typically don't feel any lump or bulge and the scar from the implant procedure is usually barely perceptible, even if you know where to look. This design eliminates the need for more invasive tunneling and a separate pocket for an implanted battery, while empowering patients to regain control of their OAB symptoms and life.2 The Neuspera System has FDA clearance for treating chronic pain of peripheral nerve origin and is currently an investigational device for treating UUI, a symptom associated with OAB. About Neuspera Medical Neuspera Medical, Inc. is committed to developing implantable medical devices that will improve the lives of patients battling chronic illnesses. The Neuspera platform is designed to provide patients and physicians with new, and potentially earlier, treatment options that are less invasive and more adaptable. These therapeutic alternatives aim to help patients restore their health and well-being for a better quality of life. For more information, please visit . About Olympus At Olympus, we are committed to Our Purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states. For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world. For more information, visit olympus-global.com and follow our global X account: @Olympus_Corp. Olympus Innovation Ventures is the venture capital arm of Olympus. OIV invests in customer driven solutions in medical devices, diagnostics and digital health that complement or extend our market leading endoscopic procedures. Get in touch with OIV at [email protected] or . About Vertex Ventures HC Vertex Ventures HC (San Francisco, CA) invests in various sectors of the healthcare industry, including biopharmaceuticals and medical devices. The Vertex portfolio includes companies at all stages of development, from early-stage companies testing transformative technologies to commercial-stage companies seeking additional growth. With a focus on areas with significant unmet need, Vertex seeks to build great companies that improve the health and quality of human life. Vertex will take an active role in their portfolio companies and work with exceptional entrepreneurs, industry partners and fellow venture investors to create value. The global investment professionals at Vertex bring deep scientific, medical and business knowledge to every investment they make. About Treo Ventures The Treo team brings more than 90 years of cumulative healthcare experiences as investors, company founders, and operator, investing globally in more than 45 companies through multiple market cycles. The Treo team has been involved in several premium healthcare companies bringing novel technologies to market that have become the standard of care. With their experiences across both early and commercial stage companies, the Treo team has played active and important roles from founding companies to liquidity via trade sales to multiple strategics and IPOs. Treo's experiences on private and public company boards gives them a unique vantage point in their active involvement with portfolio companies. In addition, their scientific and commercial backgrounds along with global relationships have helped them play an important role in consistently building some of the most successful healthcare companies over last two decades. 1 Stewart et al. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003 May;20(6):327-36. 2 Based on outcomes of the SANS-UUI Phase I clinical data; Padron et al. (2021). TREATMENT OF URINARY URGENCY INCONTINENCE (UUI) WITH AN ULTRA-MINIATURIZED SACRAL NERVE MODULATION (SNM) SYSTEM: PRELIMINARY OUTCOMES OF THE SANS-UUI STUDY. Journal of Urology. 2021 Sep 1;206(Supplement 3):e1158. Media Contact: Hyedi Nelson Bellmont Partners 651-757-7054 [email protected] SOURCE Neuspera Medical, Inc.