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Step Study Results Demonstrate Sustained Therapeutic Effects of Percutaneous Tibial Nerve Stimulation at 24 Months Patients treated with Urgent PC over 2 years sustained the benefits experienced after initial 12 weeks of therapy
Par Uroplasty, Inc. on 6 juin 2012
MINNEAPOLIS, June 6, 2012 /PRNewswire via COMTEX/ -- - Uroplasty, Inc.
(NASDAQ:UPI), a medical device company that develops, manufactures and markets innovative proprietary products for the treatment of voiding dysfunctions, today highlighted results of the STEP Study on percutaneous tibial nerve stimulation (PTNS) treatments for overactive bladder (OAB) using Uroplasty's Urgent PC Neuromodulation System. The study will be published in a future print edition of Neurourology and Urodynamics and the abstract is now available on line at.
This multi-center trial, led by Dr. M. Kenneth Peters, Chairman of the Department of Urology at Beaumont Hospital in Royal Oak, Michigan, followed for up to 24 months patients who initially responded to 12 weekly Urgent PC treatments. There were no device related adverse events throughout the study.
With a single Urgent PC treatment at an average of 1.3 times per month, patients continued to experience statistically significant improvements in voiding frequency, urinary urge incontinence episodes, nighttime voids, urgency episodes and voids with moderate to severe urgency, voiding volume and quality of life measures compared to before they began treatment with Urgent PC.
"This publication of long term data demonstrates the durability of PTNS therapy and the continued success that patients experience after their initial 12 weekly treatments," said Dr. Kenneth Peters, lead investigator. "Unlike other treatments for the chronic condition of OAB that require continuous treatment to maintain their effects, this therapy can be administered at approximately monthly intervals to sustain voiding symptom improvement. It is office-based and minimally invasive making it an ideal therapy option for those patients refractory to OAB drug therapy and other conservative therapy." "We believe these results support the continued use of Urgent PC to sustain the original success these patients experience," said Dave Kaysen, President and Chief Executive Officer of Uroplasty, Inc. "We will use this study as part of our efforts to expand awareness of the benefits of Urgent PC with Medicare and commercial Medical Directors." About the Urgent PC Neuromodulation System The Urgent PC Neuromodulation System is a proprietary, minimally invasive, percutaneous tibial nerve stimulation (PTNS) device designed for office-based treatment of overactive bladder (OAB) and the associated symptoms of urinary urgency, urinary frequency and urge incontinence.
About Uroplasty, Inc.
Uroplasty, Inc., headquartered in Minnetonka, Minnesota, with wholly-owned subsidiaries in The Netherlands and the United Kingdom, is a medical device company that develops, manufactures and markets innovative proprietary products for the treatment of voiding dysfunctions. Our primary focus is the commercialization of our Urgent PC Neuromodulation System, the only FDA-cleared neuromodulation system that delivers percutaneous tibial nerve stimulation for the office-based treatment of overactive bladder and associated symptoms of urgency, frequency and urge incontinence. We also offer Macroplastique Implants, a urethral bulking agent for the treatment of adult female stress urinary incontinence primarily due to intrinsic sphincter deficiency. Please visit Uroplasty, Inc. at
Forward Looking Statements This press release contains forward looking statements that reflect our best estimates regarding future events and financial performance. These forward looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our anticipated results. We discuss in detail the factors that may affect the achievement of our forward looking statements in our Annual Report on Form 10-K filed with the SEC. In particular, we cannot be certain that we will ever achieve sustained profitability; that the rate of reimbursement for PTNS treatments will be adequate to justify the cost of our product; that other Medicare carriers or private payers will provide coverage for this treatment or that existing carriers and payers will not change their coverage decisions; that the rate of adoption of our products by new customers will continue; that we will be able to complete the design and development of, or to manufacture, an implantable device at an effective cost; that clinical trials of that implantable device, or of a fecal incontinence device, will prove favorable; that the data and results of those clinical trials will prove acceptable to the FDA and other regularity bodies or that we will be granted clearance to market the devices; or that even if marketable, we will be able to obtain appropriate reimbursement for the implantable and fecal incontinence devices; or that any of the other risks identified in our 10-K will not adversely affect our expectations as described in these forward looking statements.
For Further Information: Uroplasty, Inc. EVC Group David Kaysen, President and CEO, or Jenifer Kirtland (Investors) Medi Jiwani, Vice President, CFO, and Treasurer, 415.568.9349 952.426.6140 Chris Gale (Media) 646.201.5431 SOURCE Uroplasty, Inc.
Copyright (C) 2012 PR Newswire. All rights reserved -0- KEYWORD: Minnesota INDUSTRY KEYWORD: MEQ
Afraid to Speak Up at the Doctor’s Office
Par PAULINE W. CHEN, M.D. on 31 mai 2012
A friend of mine, a brilliant and accomplished academic in her 70s who once specialized in history and literature, recently phoned to ask for medical advice after being discharged from the hospital for what sounded like a mini-stroke. Ever eager to learn something new, she pressed me on “the latest research” and asked what doctors around the country were doing for her condition.
We discussed a few research studies, diagnostic tests and treatment options, but when I suggested she speak with her primary care doctor and perhaps a neurologist, her end of the line went silent. I wondered if my cellphone had dropped the connection or, for a single harrowing second, if my friend was having another strokelike event.
When she finally spoke again, her once-confident voice sounded nearly childlike. “I don’t really feel comfortable bringing it up,” she said. While her doctor was generally warm and caring, “he seems too busy and uninterested in what I feel or want to say.”
“I don’t want him to think I’m questioning his judgment,” she added. “I don’t want to upset him or make him angry at me!”
For over a generation now, efforts to make health care more patient-friendly have focused on getting patients and doctors to work together to make decisions about care and treatment. Numerous research papers, conferences and advocacy organizations have been devoted to this topic of “shared decision-making,” and even politicians have clambered aboard the train, devoting several provisions in the Affordable Care Act to “preference-sensitive care.”
But one thing has been missing in nearly all of these earnest efforts to encourage doctors to share the decision-making process. That is, ironically, the patient’s perspective.
Now a study published in the most recent issue of Health Affairs has begun to uncover some of that perspective, and the news is not good. In our enthusiasm for all things patient-centered, we seem to have, as the saying goes, taken the thought of including patient preferences for the deed.
The researchers conducted several focus groups with 48 patients from five primary care physicians in the San Francisco Bay area. First, they showed the patient participants a short video on several equally effective but very different treatment approaches for a heart ailment. Then, they asked them questions about what they did with their own doctors when faced with a choice among several treatment options that might be equally effective but could differ in lifestyle effects, cost or range of complications. Finally, the researchers asked the participants if they were comfortable asking doctors about different treatments, discussing their values and preferences or disagreeing with their doctors’ recommendations.
The participants responded that they felt limited, almost trapped into certain ways of speaking with their doctors. They said they wanted to collaborate in decisions about their care but felt they couldn’t because doctors often acted authoritarian, rather than authoritative. A large number worried about upsetting or angering their doctors and believed that they were best served by acting as “supplicants” toward the doctor “who knows best.” Many also believed that they could depend only on themselves for getting more information about treatments or diseases. Some even said they feared retribution by doctors who could ultimately affect their care and how they did.
The findings fly in the face of previous optimistic assumptions about shared decision-making that were based mostly on studies that examined physicians’ intent, but not patient perceptions. “Many physicians say they are already doing shared decision-making,” said Dominick L. Frosch, lead author of the new study and an associate investigator in the Department of Health Services Research at the Palo Alto Medical Foundation Research Institute in California. “But patients still aren’t perceiving the relationship as a partnership.”
Interestingly, most participants in this study were over 50, lived in affluent areas and had either attended or completed graduate school. “It’s hard to think that people from more disadvantaged backgrounds would find it any easier to question doctors,” Dr. Frosch said.
While understanding health care issues and making themselves heard in discussions were not difficult in general for the participants in the study, the skills and confidence they had in other settings appeared to have little relevance once they were in their doctors’ offices. They could not speak as easily as they normally did. “People experience a different sense of self in the doctor-patient interaction,” Dr. Frosch observed. “The clinical context creates a reluctance to be more assertive.”
Dr. Frosch and his colleagues are working on a larger study examining the extent to which patients feel constrained. And they have plans to study whether there are better ways to encourage patient engagement.
Systemic changes to increase shared decision-making must be addressed as well. Care organizations and doctors’ practices must be restructured to allow more in-depth conversations; clinicians need to be reimbursed for the time required for more meaningful conversations; and health care systems must adopt rigorous quality standards that measure and value real patient engagement in decisions.
“We urgently need support of shared decision-making that is more than just rhetoric,” Dr. Frosch said. “It may take a little longer to talk through decisions and disagreements; but if we empower patients to make informed choices, we will all do much better in the long run.”
New York Times Well Blog
Percutaneous Tibial Nerve Stimulation Included in the American Urological Association's Overactive Bladder Clinical Treatment Guidelines Source: PR Newswire (http://s.tt/1cpdI)
Par Unknown on 21 mai 2012
MINNEAPOLIS, May 21, 2012 /PRNewswire/ -- Uroplasty, Inc. (NASDAQ: UPI), a medical device company that develops, manufactures and markets innovative proprietary products for the treatment of voiding dysfunctions, today announced that the American Urological Association (AUA) issued a clinical guideline titled "Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults," which includes percutaneous tibial nerve stimulation (PTNS) as an integral part of the care path for overactive bladder (OAB) treatment. The AUA's evidence-based guidelines are intended to promote the highest standards of clinical care. Uroplasty's Urgent® PC Neuromodulation System is the only FDA cleared device that delivers PTNS.
"It is noteworthy that the world's most prestigious urology society has recognized the clinical significance of PTNS in their OAB treatment guidelines," said David Kaysen, President and CEO of Uroplasty. "We will present these guidelines to the medical directors of U.S. private payers and Medicare carriers as we continue our efforts to expand coverage for our Urgent PC Neuromodulation System."
About Uroplasty, Inc.
Uroplasty, Inc., headquartered in Minnetonka, Minnesota, with wholly-owned subsidiaries in The Netherlands and the United Kingdom, is a medical device company that develops, manufactures and markets innovative proprietary products for the treatment of voiding dysfunctions. Our focus is the continued commercialization of our Urgent PC system, which we believe is the only FDA-approved minimally invasive nerve stimulation device designed for office-based treatment of urinary urgency, urinary frequency and urge incontinence – symptoms often associated with overactive bladder.
We also offer Macroplastique Implants®, an injectable urethral bulking agent for the treatment of adult female stress urinary incontinence primarily due to intrinsic sphincter deficiency. For more information on the company and its products, please visit Uroplasty, Inc. at www.uroplasty.com.
This press release contains forward-looking statements that reflect our best estimates regarding future events and financial performance. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our anticipated results. We discuss in detail the factors that may affect the achievement of our forward-looking statements in our Annual Report on Form 10-K filed with the SEC. In particular, we cannot be certain that we will ever achieve sustained profitability, that the rate of reimbursement for PTNS treatments will be adequate to justify the cost of our product, that other Medicare carriers or private payers will provide coverage for this treatment or that existing carriers and payers will not change their coverage decisions, that the rate of adoption of our products by new customers will continue, or that any of the other risks identified in our 10-K will not adversely affect our expectations as described in these forward-looking statements.
For Further Information:
David Kaysen, President and CEO, or
Medi Jiwani, Vice President, CFO, and Treasurer,
Jenifer Kirtland (Investors)
Chris Gale (Media)
Source: PR Newswire (http://s.tt/1cpdI)
OAB Sufferers Less Physically Active
Par Stephan Cho on 19 mai 2012
ATLANTA—Men and women with overactive bladder (OAB) are significantly less likely to achieve recommended physical activity levels than those with no or minimal symptoms (NMS) of OAB, according to a poster presentation at the American Urological Association 2012 annual meeting.
Based on responses to an Internet survey conducted in June 2010, Karin S. Coyne, PhD, MPH, of United BioSource Corporation in Chevy Chase, Md., and colleagues compared 2,323 individuals with OAB (818 men and 1,505 women) and 3,472 with NMS.
OAB sufferers were significantly more likely to have a higher body mass index compared with NMS subjects. They also were significantly less likely to report moderate and vigorous physical activity levels compared with subjects with NMS (42.5% vs. 52.5% and 30.6% vs.43.9%, respectively).
The mean hours of time spent sitting were significant higher for both men and women with OAB (mean 7.5 hours for both) than for men and women with NMS (mean 6.6 and 6.9 hours, respectively), according to investigator Tamara Bavendam,, MD, who presented study findings.
“More research is needed to further evaluate the relationship of OAB with physical activity and health status,” the authors concluded. “Longitudinal studies that assess physical activity based on contemporary guidelines and include assessments of comorbid conditions would offer the most useful information."
Renal & Urology News
Bacteria study may change how urinary tract infections are diagnosed
Par Leslie Mann on 16 mai 2012
For years, doctors have believed that urine is germ-free, so examining it for bacteria has been the standard procedure for diagnosing various maladies, including urinary tract infections.
But researchers at Loyola University Chicago Stritch School of Medicine have debunked this myth by determining that among women, even healthy patients have bacteria in their urinary systems. These bacteria, however, are not necessarily identified by conventional urine cultures.
Urinary tract infections, or UTIs, are common and can occur anywhere along the urinary tract, according to the National Institutes of Health. They are more common among women than men and tend to occur more often after menopause.
"This tells us we have to develop better diagnoses and treatment," said Dr. Linda Brubaker, urogynecologist at Loyola and co-author of the study. "Antibiotics are not always the answer. We need to do more research to know what bacteria are normal in the urinary system and what are abnormal."
In addition to UTIs, the study will affect the diagnosis and treatment of other urinary conditions, Brubaker said. Overactive bladder is a common condition among men and women, she said, and causes urinary urgency and often incontinence. The typical treatments — behavioral changes and oral medications — only help in half of the cases. "It may be that our finding of bacteria in the bladder is an important clue as to the cause of this condition, which is otherwise poorly understood," she said.
The study begins to explain why some women feel UTI symptoms but test negative with urine cultures, while others feel no UTI symptoms but test positive for bacteria in the bladder, Brubaker said. "When tests come back negative, doctors can be stumped for a diagnosis and struggle to provide long-term symptom relief," she said. "Our study may open a new line of investigation that can help these patients and their doctors."
The study included urine collected by urinating in cups and urine collected through catheters. Catheters provided more accurate testing.
For now, though, the urine-cup test will remain the standard UTI test, Brubaker said. "But this study will lead to improved diagnoses, patient-specific treatments and prevention through better understanding of bacteria," she said.
Doctors already knew that healthy people have bacteria in other parts of their bodies, including their mouths and bowels and on their skin, Brubaker said. "But we didn't think we had bacteria in the healthy bladder," she said. "Now we know we do."
The study may result in a new definition of "infection," Brubaker said. "We used to think that in the bladder, bacteria equaled infection," she said. "Now, not necessarily so. More research will be needed to fully understand this important finding."
The study was published in the April issue of the Journal of Clinical Microbiology.
Journal of Clinical Microbiology
AltheRx Presents Positive Phase II Results of Solabegron in Overactive Bladder at the American Urological Association Annual Meeting Read more: http://www.pharmiweb.com/pressreleases/pressrel.asp?ROW_ID=58890#ixzz1vcutPo8G
Par AltheRx Pharmaceuticals on 14 mai 2012
AltheRx Pharmaceuticals, a privately-held clinical development company, presented positive results from its Phase II study of Solabegron in overactive bladder (OAB) at the American Urological Association Annual Meeting (Abstract # 520). Solabegron is a novel beta3-adrenoceptor agonist with high affinity and selectivity that is in late stage clinical development for the treatment of OAB and irritable bowel syndrome (IBS).
The Phase II multi-center, randomized, double-blind, placebo-controlled, parallel group study compared two dosage strengths of Solabegron (50 mg and 125 mg) to placebo in 258 women with moderate to severe OAB symptoms (averaging 4.5 incontinence episodes per day), more than half of whom had unsuccessful prior treatment with muscarinic agents. Solabegron 125 mg, dosed twice daily over 8 weeks, produced a 65.6 percent reduction from baseline in incontinence episodes, a statistically significant adjusted mean difference from placebo of 21 percent (p=0.025). Patients treated with Solabegron also reported a significant reduction in the frequency of urination (-0.8; p=0.036), and a marked and significant increase in the volume of urine voided (+27%; p<0.001) both compared to placebo.
“The results are encouraging, particularly for patients who found no relief from, or could not tolerate, standard therapy,” said Roger R. Dmochowski, M.D., Professor, Department of Urology Vanderbilt University Medical Center. "With a novel mechanism of action, Solabegron may offer an important new treatment modality in OAB that may help us improve patients' symptoms and quality of life. Results of future Phase III clinical trials are awaited to further assess the therapeutic benefits of this compound."
Study results also demonstrated that Solabegron 125 mg was safe and well-tolerated. Adverse events did not differ between the placebo and active treatment groups. Headache and nasopharyngitis were the most frequently reported adverse events across treatment groups with no notable changes in any cardiovascular parameters measured by 24 hour ambulatory blood pressure, clinical chemistry, hematology, or ECG parameters. Urinary retention was not observed.
A Phase IIb/III study of Solabegron in OAB is planned to start enrolling later this year.
About Overactive Bladder
Overactive bladder (OAB) is a common bladder control problem that affects an estimated 80 million people worldwide, including more than 35 million Americans. The symptoms of OAB include an urgent need to urinate, frequent urination, and sometimes leaking urine before reaching the toilet, a condition also known as urge incontinence. The condition can have an extremely negative impact on a person’s quality of life, affecting work, social activities, sexual intimacy and self-esteem.
About AltheRx Pharmaceuticals
Formed in 2010, AltheRx Pharmaceuticals is a privately held development company whose business model is to advance projects through clinical development and create partnerships with biopharmaceutical companies for commercialization. The Company’s first product, Solabegron, is a highly selective and potent beta3-adrenoceptor agonist in development for the reduction of symptoms of Overactive Bladder and Irritable Bowel Syndrome. For more information, visit www.altherx.com.
Touch of Life Technologies' New Cystoscopy and Bladder Injection Simulator Offers Urologists Training on Use of BOTOX(R) (onabotulinumtoxinA) as Treatment for Urinary Incontinence in Adults With Neurological Conditions
Par Unknown on 8 mai 2012
DENVER, CO, May 08, 2012 (MARKETWIRE via COMTEX) -- Touch of Life Technologies (ToLTech) has developed a virtual reality-based cystoscopy simulator to train and evaluate urologists on the procedure of injecting BOTOX(R) (onabotulinumtoxinA) into the detrusor muscle of the bladder to treat leakage of urine (incontinence) in adults with overactive bladder due to neurologic condition. Candidates would include adults with conditions such as multiple sclerosis (MS) or spinal cord injury (SCI) -- who still have leakage or experience too many side effects after trying an anticholinergic medication.(1) BOTOX(R) was approved in August of 2011 by the United States Food and Drug Administration (FDA) for this indication.
"The cystoscopy and injection trainer manipulates image data to simulate the look and feel of a human bladder so that the physician/user actually 'feels' the resistance to the needle as it penetrates the detrusor muscle of the bladder wall," said Vic Spitzer, CEO of ToLTech. "The bladder is the proper volume and is inflated to the appropriate wall tension that would exist in candidates for this procedure. The simulator provides urologists with a realistic and accurate training method to help them become experienced at injecting BOTOX(R) into the bladder."
Newest Medical Procedure Simulator The cystoscopy trainer is the latest in a series of anatomically detailed, high-end medical procedure simulators from ToLTech. The simulator was developed to support global health care company Allergan's commitment to educate and train urologists on the proper technique for injecting BOTOX(R) to treat incontinence in adults with overactive bladder due to neurologic condition as a second-line treatment when anticholinergic medications have failed or were intolerable. The simulator and injection procedures comply with the instructions for use outlined in the product label approved by the FDA for this BOTOX(R) indication.
"Allergan's commitment to bringing forth novel treatment options for urologists and their patients extends to providing comprehensive physician education and hands-on training," said Lori Lyons, Allergan Senior Director of Marketing, Urology. "We are pleased to have the ToLTech training simulator as a part of Allergan's overall training platform as it provides urologists with a technologically-advanced method to gain experience with injecting BOTOX(R) into the detrusor muscle of the bladder as a treatment for refractory urinary incontinence in adults with overactive bladder due to an underlying neurological condition."
ToLTech's interactive products are based on photographic images from the National Library of Medicine's Visible Human Project(R) and similar higher resolution images. The sensation of feeling is provided by Geomagic (formerly Sensable Technologies) Phantom(R), a highly-developed force-feedback device interacting with these high-resolution images using custom-developed ToLTech algorithms. The simulator is designed to be lightweight for portability and incorporates an all-in-one computer with the ToLTech interface to the clinical cystoscope.
About ToLTech Touch of Life Technologies is a medical education company that develops and sells interactive software and medical procedure simulators. ToLTech products provide a virtual learning environment combining state-of-the-art interactive technology with real anatomy from the National Library of Medicine's Visible Human Project(R) as well as higher resolution images. In business more than a decade, Touch of Life Technologies ( www.toltech.net ) collaborates with professional medical societies, educators and practicing professionals to create and test next-generation tools to educate and train a wide range of healthcare professionals and students. For more information, visit www.toltech.net or call 720-859-4140.
BOTOX(R) Indication(1): BOTOX(R) is a prescription medicine that is injected into the bladder muscle and used to treat leakage of urine (incontinence) in adults 18 years and older with overactive bladder due to neurologic disease who still have leakage or experience too many side effects after trying an anticholinergic medication.
IMPORTANT SAFETY INFORMATION BOTOX(R) may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX(R):
-- Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months -- Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing. If thishappens, do not drive a car, operate machinery, or do other dangerousactivities
Do not take BOTOX(R) if you: are allergic to any of the ingredients in BOTOX(R) (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc(R) (rimabotulinumtoxinB), Dysport(R) (abobotulinumtoxinA), or Xeomin(R) (incobotulinumtoxinA); have a skin infection at the planned injection site.
Do not take BOTOX(R) for the treatment of urinary incontinence if you: have a urinary tract infection (UTI) or cannot empty your bladder on your own and are not routinely catheterizing.
The dose of BOTOX(R) is not the same as, or comparable to, another botulinum toxin product.
Serious and/or immediate allergic reactions have been reported. These reactions include itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or get medical help right away if you experience any such symptoms; further injection of BOTOX(R) should be discontinued.
Tell your doctor about all your muscle or nerve conditions such as amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease), myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including severe dysphagia (difficulty swallowing) and respiratory compromise (difficulty breathing) from typical doses of BOTOX(R).
Tell your doctor if you have any breathing-related problems. Your doctor will want to monitor you for any breathing problems during your treatment with BOTOX(R) for detrusor overactivity associated with a neurologic condition. The risk of pulmonary effects in patients with compromised respiratory status is increased in patients receiving BOTOX(R).
Autonomic Dysreflexia and Urinary Retention in Patients Treated for Detrusor Overactivity Associated With a Neurologic Condition
Autonomic dysreflexia associated with intradetrusor injections of BOTOX(R) could occur in patients treated for detrusor overactivity associated with a neurologic condition and may require prompt medical therapy. In clinical trials, the incidence of autonomic dysreflexia was greater in patients treated with BOTOX(R) 200 Units compared with placebo (1.5% versus 0.4%, respectively).
In clinical trials, 30.6% of patients (33/108) who were not using clean intermittent catheterization (CIC) prior to injection, required catheterization for urinary retention following treatment with BOTOX(R) 200 Units as compared to 6.7% of patients (7/104) treated with placebo. The median duration of post-injection catheterization for these patients treated with BOTOX(R) 200 Units (n=33) was 289 days (minimum 1 day to maximum 530 days) as compared to a median duration 358 days (minimum 2 days to maximum 379 days) for patients receiving placebo (n=7).
Among patients not using CIC at baseline, those with MS were more likely to require CIC post-injection than those with SCI.
Due to the risk of urinary retention, only patients who are willing and/or able to initiate catheterization post-treatment, if required, should be considered for treatment.
In patients who are not catheterizing, post-void residual (PVR) urine volume should be assessed within 2 weeks post-treatment and periodically as medically appropriate up to 12 weeks. Catheterization should be instituted if PVR urine volume exceeds 200 mL and continued until PVR falls below 200 mL. Patients should be instructed to contact their physician if they experience difficulty in voiding as catheterization may be required.
Human albumin and spread of viral diseases. BOTOX(R) contains albumin, a protein component of human blood. The potential risk of spreading viral diseases (eg, Creutzfeldt-Jakob disease [CJD]) via human serum albumin is extremely rare. No cases of viral diseases or CJD have ever been reported in association with human serum albumin.
Tell your doctor about all your medical conditions, including if you: have or have had bleeding problems; have plans to have surgery; had surgery on your face; weakness of forehead muscles, such as trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; have symptoms of a urinary tract infection (UTI) and are being treated for urinary incontinence. Symptoms of a urinary tract infection may include pain or burning with urination, frequent urination, or fever; have problems emptying your bladder on your own and are being treated for urinary incontinence; are pregnant or plan to become pregnant (it is not known if BOTOX(R) can harm your unborn baby); are breastfeeding or plan to breastfeed (it is not known if BOTOX(R) passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. Using BOTOX(R) with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX(R) in the past.
Especially tell your doctor if you: have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc(R), Dysport(R), or Xeomin(R) in the past (be sure your doctor knows exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take anti-platelets (aspirin-like products) or anticoagulants (blood thinners).
Other side effects of BOTOX(R) include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes; urinary tract infection and/or inability to empty your bladder on your own (in people being treated for urinary incontinence).
For more information refer to the Medication Guide or talk with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see BOTOX(R) full Product Information including Boxed Warning and Medication Guide.
BOTOX(R) is a registered trademark of Allergan, Inc. Myobloc(R) is a registered trademark of Solstice Neurosciences, Inc. Dysport(R) is owned by Tercica, Inc., a subsidiary of the Ipsen Group Xeomin(R) is a registered trademark of Merz Pharma GmbH & Co KGaA
Phantom(R) is a registered trademark of Geomagic Haptic Technology Group.
1. BOTOX(R) Prescribing Information
Image Available: http://www2.marketwire.com/mw/frame_mw?attachid=1975951
Few patients stick with overactive bladder drugs
Par David Douglas on 27 avril 2012
NEW YORK (Reuters Health) – Within months, many UK patients give up on antimuscarinics for overactive bladder (OAB), a study there shows.
As Dr. Adrian Wagg, who led the study, told Reuters Health by email, “The recent analysis of GP prescriptions of antimuscarinics for overactive bladder showed generally poor persistence with this class of drugs. Persistence was highest for the drug solifenacin (Vesicare), and in older, rather than younger people.”
“At the moment,” he added, “only in Japan is there licensed a drug from a different class — mirabegron, a beta 3 agonist.” (Earlier this month, a U.S. Food and Drug Administration advisory panel voted to recommend approval of mirabegron, with a final decision expected at the end of June.)
Antimuscarinics have adverse effects, the most common being dry mouth, and several weeks of treatment is needed before they are fully effective. Many people find the balance of adverse effects and benefits to be unsatisfactory and they cease therapy, Dr. Wagg, from Canada’s University of Alberta in Edmonton, and colleagues noted in a report online March 12 in BJU International.
The report analyzes 12 months of prescription data on 4,833 patients who started treatment for OAB in 2007. The most prescribed drug was tolterodine extended release (Detrol LA; 1,758 patients) and the least prescribed was darifenacin (Enablex in the US and Canada, Emselex in Europe; 23 patients).
At three months, 58% of those prescribed solifenacin continued to take it. For darifenacin, the proportion was 52%, for tolterodine extended release (ER) 47%, for propiverine ((Detrunorm) 47% and for tolterodine immediate release (IR) 46%. For oxybutynin ER (Ditropan XL) the proportion was 44%, for trospium (Sanctura) 42%, for oxybutynin IR it was 40% and for flavoxate (Urispas), it was 28%.
At 12 months, compliance had fallen further, to 35% for solifenacin, 28% for tolterodine ER, 27% for propiverine, 26% for oxybutynin ER, 26% for trospium, 24% for tolterodine IR, 22% for oxybutynin IR, 17% for darifenacin, and 14% for flavoxate.
The drug people took the longest was solifenacin (mean duration of therapy, 187 days). The average persistence with other agents ranged from 77 to 157 days. Subgroup analysis showed that patients at least 60 years old were more likely than younger patients to persist with their treatment.
Given these findings, Dr. Wagg concluded, “There is much to do to improve adherence with medication for OAB, a very common and troublesome condition and further work to be done to understand the reasons for persistence or non-adherence with treatment.”
Caffeine not tied to worsening urinary incontinence
Par Andrew M. Seaman on 27 avril 2012
NEW YORK — Women with urinary incontinence who also enjoy their regular cup of coffee or tea don’t have to worry about the extra caffeine making their condition worse, suggests a new study.
The new research stands in contrast to the common recommendation that women with leaky bladders stay away from caffeinated foods and beverages.
“If a woman feels she wants to abstain from caffeine that’s completely fine, but based on our results, women with moderate incontinence shouldn’t be concerned,” said Mary Townsend, the study’s lead author from Brigham and Women’s Hospital and Harvard Medical School in Boston.
Still, the findings cannot say whether caffeine might have a shorter-term impact by making women need to urinate soon after eating or drinking something caffeinated.
According to Townsend, there are some biological reasons for women with incontinence to stay away from caffeine — such as that it increases the production of urine and may give some the urge to go.
But it’s been unclear whether a daily caffeine habit is tied to worsening incontinence over the long run.
To try to answer that question, the researchers looked at data on about 21,500 women enrolled in two large studies, each of which tracked the long-term health of U.S. nurses through surveys starting in the 1970s or 1980s.
Townsend and her colleagues selected women with moderate incontinence — defined as leaking urine one to three times per month — from participants who were asked about incontinence and caffeine consumption in 2002 or 2003.
The women were questioned about how much caffeine they ate or drank in the form of coffee, tea, soda or chocolate over the previous few years.
Two years later, when they were again surveyed about incontinence, about 20 per cent of women said their symptoms had gotten worse and they now leaked urine at least once per week. That was consistent regardless of how much caffeine they’d reported eating and drinking.
The researchers also didn’t find a link between women who increased their caffeine consumption between the survey years and worsening urinary symptoms — either for general incontinence or for overactive bladder in particular. Women can also suffer from stress and overflow incontinence, said Dr. Larissa Rodriguez, co-director of the division of female urology, reconstructive surgery and urodynamics at the David Geffen School of Medicine at the University of California, Los Angeles.
Leaks related to stress incontinence can be brought on by any activity that puts stress on the bladder, like sneezing or laughing. Overflow incontinence occurs when the bladder does not empty properly, and urge incontinence or overactive bladder is the sudden need to go the bathroom.
As for treatments, behavioural changes, weight loss and certain exercises may help, said Rodriguez, who wasn’t involved in the new study.
“There are not many effective medications but minimally invasive surgeries can be curative,” she added.
According to the National Institutes of Health, which funded the study, the majority of women can get relief without surgery.
Townsend said most women in the study did not even tell their doctors about their incontinence.
She also said the new findings, published in Obstetrics & Gynecology, need to be confirmed with more research because there’s a possibility that caffeine could make urinary symptoms worse over longer than a few years.
The study was also limited because incontinence symptoms were reported by the women themselves and not measured by a doctor, and the researchers didn’t take treatment for incontinence into consideration.
Addex: PAM du récepteur GABAB (vessie hyperactive) désormais en phase I
Par Addex Therapeutics on 20 avril 2012
Genève (awp) - Addex Therapeutics a réalisé de bons résultats de tests précliniques avec le modulateur allostérique positif (PAM) du récepteur GABAB, l'ADX71441. Le programme de recherche et développement pour le produit candidat destiné à soigner la vessie hyperactive est en bonne voie, a indiqué lundi la société dans un communiqué. La demande d'études cliniques (demande IND) doit être faite avant la fin de cette année.
Les thérapies autorisées à ce jour destinées au traitement de la vessie hyperactive sont peu efficaces et provoquent des effets secondaires importants, précise le communiqué. Aux USA, 11 à 16 mio de femmes souffrent de vessie hyperactive. Selon les estimations, la fréquence chez les hommes devrait être la même.
Addex présentera les données des études précliniques pour les produits candidats au congrès annuel de l'American Urology Association à Atlanta, qui aura lieu du 19 au 23 avril.