product approval introduction

URO-1’s Repris System for Injecting Botox Into Bladder

URO-1, based in Winston-Salem, North Carolina, got FDA approval for its Repris Bladder Injection System. The product is designed for delivering Botox injections into the bladder as a treatment option for overactive bladder. The device, which is supposed to make such procedures easier on the physicians and more comfortable on the patients, will be unveiled at the American Urological Association in San Francisco later this month. Read more.

Source: Medgadget, May 9, 20218

product approval introduction

FDA Approves Myrbetriq Combo Treatment for Overactive Bladder

The Food and Drug Administration (FDA) has approved Myrbetriq (mirabegron extended-release tablets; Astellas) in combination with the muscarinic antagonist solifenacin succinate for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. In clinical trials, the combination of Myrbetriq + solifenacin succinate was associated with greater improvements in the number of incontinence episodes per 24 hours (primary endpoint), the number of micturitions per 24 hours (primary endpoint), and the volume voided per micturition (secondary endpoint) compared to placebo or to individual active components. Long-term data also demonstrated that the effects of combination treatment were maintained throughout a 1-year treatment period. Read more.

Source: MPR, April 30, 2018

drugs for overactive bladder (OAB)

Certain Common Medications Tied to 30% Higher Dementia Risk, Study Finds

Many older adults know that long-term use of certain medications can negatively affect cognition and increase one’s risk of dementia.  But a new study suggests that some classes of anticholinergic drugs — particularly those used to treat depression, Parkinson’s and urinary incontinence — carry a higher risk than others.  Anticholinergic drugs function by blocking the effects of acetylcholine, a chemical released by nerve cells to send signals to other nerves and muscles. They are prescribed to 20% to 50% of older adults in the United States to treat a variety of neurological, psychiatric, gastrointestinal, respiratory and muscular conditions, according to a 2009 study. In the UK, 34% to 48% of older adults take them, another study found.  Read more.

Source: CNN, April 25, 2018

tibial nerve

StimGuard Launches Head-to-Head Trial Against Medtronic’s InterStim

StimGuard yesterday announced plans for a clinical trial comparing its nerve stimulator with the InterStim sacral nerve stimulator made by Medtronic (NYSE:MDT).  Pompano Beach, Fla.-based StimGuard is already running a pivotal study of its technology, a miniature implantable device designed to treat urinary incontinence resulting from refractory overactive bladder syndrome. The device is implanted at the tibial nerve through a needle-sized introducer and uses wireless technology to stimulate the nerve. Read more.

Source: Massdevice, March 1, 2018

hurrying with overactive bladder

Innovus Pharma Announces the Publication of a Successful Clinical Trial in Overactive Bladder and Urine Incontinence Patients for its UriVarx® Product

Innovus Pharmaceuticals, Inc. (“Innovus Pharma” or the “Company”) (OTCQB Venture Market: INNV), an emerging commercial-stage pharmaceutical company that delivers safe, innovative and effective over-the-counter medicine and consumer care products to improve men’s and women’s health and respiratory diseases, today announced that the human clinical trial for the patented formulation in its product UriVarx® product for bladder health was published in the peer reviewed journal, BMC Complementary and Alternative Medicine (Schoendorfer et al. BMC Complementary and Alternative Medicine (2018) 18:42). The study was conducted by the team of Dr. Niikee Schoendorfer in Australia in collaboration with the Company’s UriVarx® licensing partner Seipel Group, Ltd. The outcome of this study demonstrated both statistical significance and clinical relevance in reducing symptoms of Overactive Bladder (“OAB”), urinary frequency and/or urgency and incontinence. Read more.

Source: Digital Journal, February 7, 2018

Botox injection overactive bladder

Sacral Neuromodulation, Botulinum Show Equal Efficacy

In patients with refractory urgency urinary incontinence (UUI), sacral neuromodulation (InterStim) and onabotulinumtoxinA (Botox) produce similar reductions in mean daily UUI episodes, according to 24-month follow-up data on patients treated in a randomized trial.  Investigators in the ROSETTA (Refractory Overactive Bladder: Sacral NEuromodulation versus BoTulinum Toxin Assessment) trial in 2016 reported that botulinum toxin at 6 months of treatment resulted in a “small daily improvement in UUI episodes” that was statistically significant (JAMA 2016; 316:1366–74).  Now, in long-term follow-up data on ROSETTA, NIH investigators reported at the International Continence Society annual meeting in Florence, Italy that the two treatments provide similar reductions in mean daily UUI episodes at 24 months. However, botulinum toxin treatment was more likely to provide complete resolution of episodes 6 months after treatment, and it was associated with higher patient satisfaction and treatment endorsement ratings over the 24 months, reported first author Christopher J. Chermansky, MD, assistant professor of urology at the University of Pittsburgh School of Medicine. Read more.

Source: Urology Times, November 14, 2017

female doctor

Botox Beats Implant for Urinary Incontinence in Women

For women with bladder incontinence who haven’t been helped by medications or other therapies, Botox injections may help control leakage better than an implanted nerve stimulation device, a new study suggests. However, both treatments are effective, according to doctors who treat the condition. In a head-to-head comparison, women given Botox saw their number of daily urgency incontinent episodes decrease by four, on average, compared to three for women who received the implant, called InterStim.  Botox patients also said they had a greater reduction in symptoms and were more satisfied with the treatment, the researchers said.  Read more.

Source: HealthDay News, October 4, 2016

Overactive Bladder (OAB) and Urge Urinary Incontinence (UUI)

hurrying with overactive bladder

You may find yourself hurrying a lot to find a bathroom if you have an overactive bladder.

Overactive bladder (OAB) is a condition in which the bladder can spasm and cause a sudden, intense and frequent urge to urinate. In some cases, these urges can lead to episodes of involuntary urine leakage, which is called urge urinary incontinence (UUI) or “UUI-wet.” Overactive bladder contractions that send you running to the bathroom quite frequently, without any leakage is referred to as “UUI-dry.”Continue reading

Botulinum Toxin (BOTOX®) Injections

doctor writing prescription for BOTOX

You and your doctor need to decide together if trying BOTOX is right for you.

Botulinum toxin (commonly called BOTOX®) is often used in cosmetic procedures.  BOTOX is also a relatively new treatment for severe urge incontinence that has not responded to medical therapy.  It is also for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and frequency.  It is only for use in adults who have had an inadequate response to, or are intolerant of, anticholinergic medication. In this treatment, BOTOX is injected directly into the bladder muscle, relaxing it and allowing the bladder to fill with more urine before the urge to urinate strikes.Continue reading