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May 08, 2012 at 16:12 PM EDT
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

DENVER, CO -- (Marketwire) -- 05/08/12 -- Touch of Life Technologies (ToLTech) has developed a virtual reality-based cystoscopy simulator to train and evaluate urologists on the procedure of injecting BOTOX® (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® 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® 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® 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® 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® 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® and similar higher resolution images. The sensation of feeling is provided by Geomagic (formerly Sensable Technologies) Phantom®, 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® 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® Indication(1):
BOTOX® 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
® 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®:

  • 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 this happens, do not drive a car, operate machinery, or do other dangerous activities

Do not take BOTOX® if you: are allergic to any of the ingredients in BOTOX® (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.

Do not take BOTOX® 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® 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® 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®.

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® 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®.

Autonomic Dysreflexia and Urinary Retention in Patients Treated for Detrusor Overactivity Associated With a Neurologic Condition
Autonomic dysreflexia associated with intradetrusor injections of BOTOX® 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® 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® 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® 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® 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® can harm your unborn baby); are breastfeeding or plan to breastfeed (it is not known if BOTOX® passes into breast milk).

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. Using BOTOX® 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® 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®, Dysport®, or Xeomin® 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® 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® full Product Information including Boxed Warning and Medication Guide.

BOTOX® is a registered trademark of Allergan, Inc.
Myobloc® is a registered trademark of Solstice Neurosciences, Inc.
Dysport® is owned by Tercica, Inc., a subsidiary of the Ipsen Group
Xeomin® is a registered trademark of Merz Pharma GmbH & Co KGaA

Phantom® is a registered trademark of Geomagic Haptic Technology Group.

Reference

1. BOTOX® Prescribing Information

Image Available: http://www2.marketwire.com/mw/frame_mw?attachid=1975951

Contact:

Peggy Gonder
303-321-3465
Gonder Public Relations
Email Contact

Karen Storck
720-859-4140
Touch of Life Technologies
Email Contact

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