Valencia Tech wins FDA nod for eCoin neurostim overactive bladder trial

Valencia Technologies said today it won FDA investigational device exemption approval to launch a pivotal trial of its eCoin neurostimulation device exploring its ability to treat overactive bladder. The system, which is approximately the size of a nickel, is designed to implanted in a 10 minute procedure and send electrical impulses to the tibial nerve to stimulate the part of the brain that controls bladder response, the New York-based company said. “There is great excitement for a therapy that delivers more than modest improvement in overactive bladder symptoms while avoiding the side-effects of drugs,” urologist Roger Dmochowski said in a press release. The trial, which is slated to be conducted at 20 centers in the US, aims to explore whether the device is superior to the leading drug designed to treat overactive bladder, Valencia Technologies said. “eCoin will change the way overactive bladder is treated because it is minimally invasive, has no side effects, and may prove to be superior in effectiveness to drugs and alternative therapies,” Valencia founder Jeff Greiner said in a prepared statement. In October 2016, Valencia said it won investigational device exemption approval from the FDA to begin a trial of its eCoin neurostimulator for treating drug-resistant hypertension. The post Valencia Tech wins FDA nod for eCoin neurostim overactive bladder trial appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Food & Drug Administration (FDA) Neuromodulation/Neurostimulation Regulatory/Compliance Valencia Technologies Source Type: news

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Conclusions: WML is associated with age and is common in the elderly population. Mild WML is subclinical, with no obvious neurological and urinary symptoms. Our cohort did not demonstrate a relationship between WML and lower urinary tract symptoms. PMID: 30155303 [PubMed]
Source: Journal of Aging Research - Category: Geriatrics Tags: J Aging Res Source Type: research
ConclusionsThe relief of key OAB symptoms produced by mirabegron 50 mg is significantly better than placebo, and similar to a range of common antimuscarinics, with the benefit of significantly fewer bothersome anticholinergic side effects such as dry mouth. Combination treatment of solifenacin 5 mg plus mirabegron 25 or 50 mg appears to provide an efficacy benefit compared with mirabegron 50 mg, with the expected side effects of individual antimuscarinics.Patient summaryThis study assessed the efficacy and tolerability of different drug treatments for OAB. Mirabegron 50 mg was as effective as antim...
Source: European Urology - Category: Urology & Nephrology Source Type: research
Mirabegron is a β3-adrenoreceptor agonist used for the treatment of overactive bladder syndrome. We evaluated the cardiovascular safety of mirabegron using pooled data from 13 studies. The analysis included 13,396 patients who received ≥1 dose of mirabegron (25 mg/50 mg) or comparator antimuscarinics (solifenaci n 2.5 mg/5 mg/10 mg or tolterodine extended release 4 mg) as monotherapies, or placebo. We focused on changes in blood pressure and cardiovascular adverse events. Baseline cardiovascular risk factors had an imbalanced effect on subsequent cardiovascular adverse events.
Source: Journal of the American Society of Hypertension - Category: Cardiology Authors: Tags: Research Article Source Type: research
ConclusionsNocturia is a common and bothersome condition affecting a large proportion of men and women aged ≥ 40 years in China, South Korea, and Taiwan. Factors associated with nocturia included age, sex, comorbid conditions, and LUTS.Trial registrationThis study is registered at ClinicalTrials.gov: NCT02618421.
Source: World Journal of Urology - Category: Urology & Nephrology Source Type: research
Conclusions A paradigm of ambulatory BP monitoring analysis designed to test BP safety of noncardiovascular drugs showed that solifenacin plus mirabegron combination therapy during 12 weeks produced no meaningful changes in BP or heart rate.
Source: Blood Pressure Monitoring - Category: Cardiology Tags: Analytical Methods and Statistical Analyses Source Type: research
Conclusions The relief of key OAB symptoms produced by mirabegron 50mg is significantly better than placebo, and similar to a range of common antimuscarinics, with the benefit of significantly fewer bothersome anticholinergic side effects such as dry mouth. Combination treatment of solifenacin 5mg plus mirabegron 25 or 50mg appears to provide an efficacy benefit compared with mirabegron 50mg, with the expected side effects of individual antimuscarinics. Patient summary This study assessed the efficacy and tolerability of different drug treatments for OAB. Mirabegron 50mg was as effective as antimuscarinic therapy, with few...
Source: European Urology - Category: Urology & Nephrology Source Type: research
Authors: Rosa GM, Baccino D, Valbusa A, Scala C, Barra F, Brunelli C, Ferrero S Abstract INTRODUCTION: Overactive bladder (OAB) syndrome is common in the general population, particularly in elderly patients. Antimuscarinic drugs (AMs) are considered the mainstay pharmaceutical treatment of OAB whereas β3-adrenoceptor agonists, such as mirabegron, represent a good alternative. Owing to the important role of muscarinic and β3 receptors in cardiovascular (CV) tissue and to the fact that OAB patients often have CV comorbidities, the safety-profile of these drugs constitute an important challenge. Area covered...
Source: Expert Opinion on Drug Safety - Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research
ConclusionsMirabegron was not inferior effective in improving OAB symptoms compared with antimuscarinic agents. In addition, mirabegron presented lower incidence of dry mouth and not higher risk for hypertension. Therefore, mirabegron has potential to be an alternative therapeutic option for OAB control.
Source: World Journal of Urology - Category: Urology & Nephrology Source Type: research
ABSTRACT Dysfunction of the autonomic nervous system afflicts most patients with Parkinson disease and other synucleinopathies such as dementia with Lewy bodies, multiple system atrophy, and pure autonomic failure, reducing quality of life and increasing mortality. For example, gastrointestinal dysfunction can lead to impaired drug pharmacodynamics causing a worsening in motor symptoms, and neurogenic orthostatic hypotension can cause syncope, falls, and fractures. When recognized, autonomic problems can be treated, sometimes successfully. Discontinuation of potentially causative/aggravating drugs, patient education, and n...
Source: Movement Disorders - Category: Neurology Authors: Tags: Review Source Type: research
This study aimed to quantify the impact of OAB on healthcare costs and assess the potential moderating effects of OAB on the costs of patients with chronic comorbidities. MethodsAdults with evidence of OAB/OAB‐related therapy between 1/1/2008‐12/31/2013 were identified from two large, administrative claims databases. Per‐patient‐per‐month (PPPM) expenditures for OAB cases were estimated and compared to those of propensity score‐matched subjects without OAB. Costs were modeled using ordinary least squares regression including main effects and interactions of chronic depression, dementia, diabetes, hypertension, ...
Source: Neurourology and Urodynamics - Category: Urology & Nephrology Authors: Tags: ORIGINAL BASIC SCIENCE ARTICLE Source Type: research
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