sacral nerve stimulation

Medtronic Touts 5-Year Data on InterStim Neuromod Device for OAB

Medtronic today touted 5-year results from the InSite study of its InterStim neuromodulation treatment for overactive bladder syndrome.  InterStim is designed to stimulate the sacral nerve to treat OAB, meaning urinary urge incontinence and/or urgency-frequency. The InSite study enrolled 340 patients, of which 272 were implanted with an InterStim device, comparing treatment with the device with standard drug therapy. The primary safety endpoint was to “demonstrate that the upper bound of the 95% CI for the cumulative five-year rate of adverse events related to the tined lead that require surgery is less than 33%” at 5 years, according to ClinicalTrials.gov. The primary efficacy endpoint was superior improvement in OAB symptoms at 6 months. Read more.

Source: MassDevice Today, July 17, 2017

doctor male discussion penile clamp

Uromedica Wins CMS Coverage for ProAct Continence Therapy Device

Uromedica said today it won a reimbursement code from the Centers for Medicaid and Medicare Services for its ProAct adjustable continence therapy for men, and that it launched the device in the US.  The ProAct system has FDA approval and is indicated for treating adult men with stress incontinence from intrinsic sphincter deficiency of at least 12 months following radical prostatectomy or TURP who have failed ot respond to conservative therapy, the Plymouth, Minn.-based company said. “The issuance of these codes will allow Uromedica to deliver its safe and effective therapy to improve the quality of life for men struggling with Stress Urinary Incontinence,” prez & CEO Tim Cook said in a press release. Read more.

Source: MassDevice Today, July 12, 2017

stem cells

Engineering Digestive System Tissues: Significant Progress

Researchers at Wake Forest Institute for Regenerative Medicine have reached important milestones in their quest to engineer replacement tissue in the lab to treat digestive system conditions — from infants born with too-short bowels to adults with inflammatory bowel disease, colon cancer, or fecal incontinence.  Reporting today in Stem Cells Translational Medicine, the research team verified the effectiveness of lab-grown anal sphincters to treat a large animal model for fecal incontinence, an important step before advancing to studies in humans. And last month in Tissue Engineering, the team reported success implanting human-engineered intestines in rodents. Read more.

Source: Science Daily, July 5, 2017

Acupuncture

Consider Acupuncture for Incontinence

Acupuncture, a 3,000-year-old healing technique, received mixed reviews in two new studies from China — one focusing on incontinence and the other on a cause of female infertility.  A research team found acupuncture did improve symptoms of stress incontinence — an involuntarily loss of urine, such as when a woman sneezes or coughs.  But in a separate study, another team of researchers determined that acupuncture did not help women who were infertile because of polycystic ovary syndrome (PCOS). Women with PCOS have a hormonal imbalance that keeps them from releasing an egg (ovulating) during the menstrual cycle. Read more.

Source: HealthDay News, June 27, 2017

business buildings

RDD Pharma Receives Orphan Designation for RDD-0315 in Spinal Cord Injury Patients

RDD Pharma, a leader in developing treatments for anorectal disorders, announced today the European Medicines Agency’s Committee for Orphan Medicinal Products has granted orphan designation for RDD-0315, an investigational drug for the treatment of fecal incontinence in patients with spinal cord injury.   The committee recognized that RDD-0315 may be of significant benefit to spinal cord injury patients affected by fecal incontinence. “We are pleased the EMA recognized the clinically significant benefit that RDD-0315 may offer spinal cord injury patients,” stated Jason Laufer, Chief Executive Officer, RDD Pharma.  ‘We have the potential to positively impact the health, well-being and quality of life in this patient population. ‘  Read more.

Source: PRNewswire, July 5, 2017

 

business buildings

Astellas Submits Supplemental New Drug Application for Mirabegron

Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the use of mirabegron in combination with solifenacin succinate 5 mg for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. In the United States, mirabegron and solifenacin succinate are marketed as Myrbetriq® and VESIcare®, respectively. Each is approved by the FDA as a monotherapy for the treatment of OAB with symptoms of urge urinary continence, urgency and urinary frequency.  Read more.

Source: PRNewswire, June 29, 2017

hurrying with overactive bladder

Identifying Overactive Bladder Syndrome

An interview with Dr Michael Kennelly, urologist and Medical Director for the Charlotte Continence Center at Carolinas Medical Center, conducted by April Cashin-Garbutt, MA (Cantab)  What are the main symptoms of overactive bladder syndrome (OAB)?  Symptoms of OAB include leakage, the strong sudden need to “go right away,” and going to the bathroom too often. Read more.

Source: News-Medical.Net, June 28, 2017

business buildings

Essity: A Hygiene And Health Powerhouse Is Spun-Off

Sweden’s Svenska Cellulosa Aktiebolaget or SCA dates back to 1929 as a holding company for ten forestry businesses. Over the proceeding decades, SCA began acquiring various hygiene businesses although they remain the largest private land owner of forest land in Europe holding roughly 2.6 million hectares (6.4 million acres). Separating these two businesses made sense and hopefully will allow the true value of each to be realized.  In 2016, Essity (OTC:ESSYY) accounted for 86% ($11.5 billion) of SCA’s total revenue so while SCA was originally founded as a forest products company, in reality, it was a health and hygiene business and had been for many years. It earned around $480 million and generated $790 million in owner earnings last year. Read more.

Source: Seeking Alpha, June 19, 2017

drugs for overactive bladder (OAB)

GTx Announces Preliminary Results with Enobosarm

GTx, Inc. (Nasdaq: GTXI) today announced release of preliminary clinical data from its ongoing, open-label, Phase 2 clinical trial of enobosarm 3 mg (GTx-024) in postmenopausal women with stress urinary incontinence (SUI). An abstract entitled “Kegels In A Bottle”: Preliminary Results Of A Selective Androgen Receptor Modulator (GTx-024) For The Treatment Of SUI In Post-Menopausal Women, summarizing clinical data from the first seven patients completing 12 weeks of treatment with enobosarm, is now available on the International Continence Society’s website. This proof-of-concept clinical trial is the first of its kind to evaluate an orally-administered selective androgen receptor modulator (SARM) for SUI. Read more.

Source: BusinessWire, June 12, 2017

women friends

Low Estrogen May Contribute to Incontinence in Women

Significantly lower levels of oestrogen in peri-menopausal and post-menopausal women could increase their risk of stress urinary incontinence, according to Austrian researchers.  They noted that sex steroid levels changed markedly during menopause, and oestrogen deficiency after menopause caused changes within the urogenital tract.  Their study included 47 women with stress urinary incontinence who were matched with 47 controls.  The findings suggested that low levels of circulating sex steroids might have a negative impact on the function of the lower urinary tract and on mechanisms involved with continence.  Read more.

Nursing Times, June 8, 2017