nurse and patient

Prasterone Shows Promise In Reducing Severity of Urinary Urge Incontinence

Because of a decrease in estrogen, menopause is often accompanied by multiple vaginal and urinary issues. To date, most treatment options focus on vulvar and vaginal atrophy, with fewer options available to treat urinary incontinence. A new study, however, suggests prasterone is effective in improving the severity of urinary urge incontinence. Study results are published online today in Menopause, the journal of The North American Menopause Society (NAMS). Read more.

Source: Newswise, July 27, 2022

clinical medical

Urovant Sciences Announces Positive Topline Results of Phase 2a Trial of its Potential Novel Gene Therapy, URO-902

Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., today announced positive topline results from its Phase 2a, double-blind, placebo-controlled exploratory study of URO-902, an investigational, novel, locally injected gene therapy product (plasmid human cDNA encoding maxi-K channel), in patients with overactive bladder (OAB), who were not well managed by oral therapies. Read more.

Source: Pharmiweb.com, March 7, 2022

drugs for overactive bladder (OAB)

Study Finds Vibegron Has No Adverse Ambulatory Effects in Patients with OAB

It is important for clinicians to perform ambulatory blood pressure monitoring (ABPM) for patients taking new prescribed medications, as they may affect blood pressure or heart rate in detrimental ways. It is especially important to monitor patients with overactive bladder (OAB), as this group has an increasing abundance of novel medicines available to them.  In a recent study presented at the 2021 American Urological Association Annual Meeting,¹ Michael A. Weber, MD, and co-authors assessed the blood pressure and heart rate profiles of the beta 3 adrenergic receptor agonist vibegron (Gemtesa) in treating patients with OAB. Read more.

Source: Urology Times, November 5 2021

clinical medical

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

women friends

Viveve Medical (VIVE) Announces Authorization to Initiate Short-Term Feasibility Study in Stress Urinary Incontinence from Canadian Ministry of Health

Viveve Medical, Inc. (NASDAQ: VIVE), a medical technology company focused on women’s intimate health, announced today that it has received approval of its Investigational Testing Application (ITA) from the Canadian Ministry of Health to conduct a three-arm, three-month feasibility study to compare Viveve’s cryogen-cooled monopolar radiofrequency (CMRF) treatment and a cryogen-only sham to an inert sham treatment for the improvement of stress urinary incontinence (SUI) in women. Read more.

Source: Street Insider, December 18, 2019

meeting conference

Axonics Provides Full One-year Results From ARTISAN-SNM Pivotal Study

Axonics announced the presentation of detailed one-year results from its ARTISAN rechargeable sacral neuromodulation (r-SMN) pivotal study at a plenary session at the joint scientific meeting of the American Urogynecologic Society (AUGS) and the International Urogynecological Association (IUGA). The presentation of positive data, as well as numerous launch activities, highlighted Axonics’ first scientific meeting following the US Food and Drug Administration (FDA) clearance of the Axonics r-SNM System1 in September 2019. During the meeting, more than 350 physicians of the approximate 2,000 at the conference, attended a one-hour symposium at which experienced physician implanters from the ARTISAN-SNM pivotal study discussed their first-hand impressions of the Axonics r-SNM System and post-implant patient feedback. Read more.

Source: Neuro News, October 7, 2019

business buildings

Axonics® Announces Publication of ARTISAN Clinical Study Results in the Journal of Urology

Axonics Modulation Technologies, Inc. (AXNX) a medical technology company focused on the development and commercialization of novel implantable Sacral Neuromodulation (“SNM”) devices for the treatment of urinary and bowel dysfunction, today announced the results from its ARTISAN-SNM study were published online in the peer-reviewed Journal of Urology (https://doi.org/10.1097/JU.0000000000000458).  This is the first journal publication to detail outcomes for patients in the United States treated with a rechargeable sacral neuromodulation system. The study, conducted under a U.S. Food & Drug Administration (FDA) Investigational Device Exemption (“IDE”), found that 90% of all implanted patients with the Axonics r-SNM® System had successful therapy outcomes. Read more.

Source: Business Wire, July 29, 2019

TARIS Announces Presentation of Clinical Data for TAR-302 for Overactive Bladder

TARIS Bio™, a biopharmaceutical company developing transformational therapies to treat people with debilitating urological disorders, announced today that results of the company’s Phase 1b study of TAR-302 for the treatment of overactive bladder (OAB) will be presented in a podium session on Wednesday, September 4th at the Annual Meeting of the International Continence Society (ICS) in Gothenburg, Sweden. The presentation will detail the safety, tolerability, pharmacokinetics and preliminary efficacy data including a durable benefit of TAR-302, which was administered to 11 OAB patients for six weeks. The abstract is available on the ICS website. Read more.

Source: PRNewswire, July 25, 2019

drugs for overactive bladder (OAB)

TARIS Bio Initiates New Clinical Study of TAR-302 in Overactive Bladder

TARIS Bio, a biopharmaceutical company developing transformational therapies to treat people with debilitating urological disorders, announced today the initiation of a new clinical investigation of TAR-302 for the treatment of overactive bladder (OAB). As a new follow-on arm of the company’s previously concluded Phase 1b trial, the study is designed to investigate the safety, tolerability, and preliminary efficacy of a single 12-week dose of the system, doubling the previous treatment experience and representing a duration that better meets the real-world needs of patients with this serious and chronic disease. Read more.

Source: Yahoo! Finance, May 1, 2019