Myrbetriq Plus Pelvic Floor Exercises Fail to Ease Overactive Bladder

Combining Myrbetriq (mirabegron) with modifications like pelvic floor exercises failed to ease overactive bladder symptoms in people with Parkinson’s disease in a pilot clinical trial, the study’s main goal.  But the treatment, approved for overactive bladder, when used with such behavioral modifications did increase the amount of urine patients were able to expel with each urination, relative to patients using only pelvic floor exercise. But this benefit was temporary. Read more.

Source: Parkinson’s News Today, December 7, 2022

clinical medical

Neuspera Medical® Announces First Successful Implant of the Nuvella™ System in the Second Phase of Its SANS-UUI IDE Clinical Trial

Neuspera® Medical, a medical device company developing implantable devices for patients battling chronic illnesses, today announced the first patient successfully implanted with the Nuvella™ system in its pivotal clinical trial (SANS-UUI). The procedure was performed by Dr. Jodi Michaels of Minnesota Urology, St. Paul, MN. The study will evaluate the safety and efficacy of the Nuvella system, designed to treat overactive bladder (OAB) with sacral neuromodulation (SNM) in patients with urinary urgency incontinence (UUI) symptoms. Read more.

Source: PRNewsire, October 10, 2022

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Medtronic Kicks Off Pivotal Study of Tibial Neuromodulation Implant for Overactive Bladder

After receiving an FDA approval last month in bladder and bowel incontinence for its neuromodulation device implanted in the lower back, Medtronic isn’t resting on its laurels.  It has begun a clinical trial of a similar system placed near the ankle, which the company described as a more convenient option that may make the therapy available to more people. The medtech giant announced that its first patients have received implants in the pivotal study, with neurostimulators that tap into the posterior tibial nerve running up the back of the leg, to transmit electrical pulses that aim to help regulate an overactive bladder. Read more.

Source: Fierce Biotech, March 25, 2022

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Axonics® Receives FDA Approval for Recharge-Free Sacral Neuromodulation System

Axonics, Inc. (Nasdaq: AXNX), a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, today announced that the U.S. Food and Drug Administration (FDA) has approved its newly developed, long-lived, recharge-free sacral neuromodulation (SNM) implantable neurostimulator (INS).  Read more.

Source: Business Wire, March 7, 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

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Medtronic Receives FDA Approval for InterStim X™ System

Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced it received approval from the U.S. Food and Drug Administration (FDA) for InterStim X™ ― the next generation of the InterStim™ portfolio’s recharge-free device – and it is available immediately. InterStim systems are the standard of care in advanced therapy options, and the most personalized system, to deliver sacral neuromodulation (SNM) therapy. Now the only SNM system backed by 90+ clinical studies, 1,000+ clinical articles, 350,000 patients treated and 25 years of experience, also offers patients a decade or more of treatment with either the new recharge-free InterStim X device, or the rechargeable InterStim™ Micro device. Both devices are used in the treatment of overactive bladder (OAB), chronic fecal incontinence (FI), and non-obstructive urinary retention. Read more.

Source: PRNewswire, February 22, 2022

product approval introduction

Tibial Nerve Stimulator Is Safe, Effective, and Durable, 12-month Data Indicate

A nickel-sized tibial nerve stimulator offers overactive bladder (OAB) patients with urgency urinary incontinence long-term outcomes comparable to other treatment options, including percutaneous tibial nerve stimulation.  Findings of a study published in Urology1 imply OAB treatment with the investigational eCoin (Valencia Technologies Corp) device is safe and achieves a durable response, says the study’s lead author, urologist Peter Gilling, MD, of Tauranga Urology Research Ltd, Tauranga, New Zealand. Read more.

Source: Urology Times, July 15, 2021

product approval introduction

FDA Authorizes Study Exploring Novel Device for Bladder Incontinence

The FDA has approved the launch of an investigational device exemption trial exploring a novel implantable tibial neuromodulation (TNM) device designed to relieve symptoms of bladder incontinence.  The trial, known as the TITAN 1 Feasibility Study, is a multicenter, prospective trial aiming to enroll 20 patients at 8 clinical sites in the United States. The patients will have the device implanted in the posterior tibial nerve near the ankle. They will be followed for 12 months to assess the feasibility of the product. Enrollment for the trial is expected to commence in May. Medtronic currently offers several products for bladder control, including the InterStim sacral neuromodulation systems and the NURO percutaneous tibial neuromodulation (PTNM). Read more.

Source: Urology Times, April 27, 2021

product approval introduction

Urovant Sciences Announces U.S. FDA Approval of GEMTESA® (vibegron) 75 mg Tablets for the Treatment of Patients with Overactive Bladder (OAB)

Urovant Sciences, Inc (Nasdaq: UROV) announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for once-daily 75 mg GEMTESA® (vibegron), a beta-3 adrenergic receptor (β3) agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults. Read more.

Source: BioSpace, December 23, 2020