Large Study Reports That 65% Of Male Patients With Stress Urinary Incontinence Were Dry At Two Years

A condition that affects over two million men, stress urinary incontinence ( SUI ) is often a disturbing complication that follows surgical removal of prostate. Until now, there have been few options for treatment of this embarrassing condition.

A product called ProACT™ ( Adjustable Continence Therapy ) , studied in recent clinical trials might provide an option for SUI patients. It's not yet approved by FDA, but early clinical trial results are now becoming available. A large sample study conducted outside the United States reports that ProACT™ ( Adjustable Continence Therapy ) , manufactured by Uromedica, Inc. , in United States, has met study criteria used to demonstrate the safety, effectiveness and durability of treatment for male stress urinary incontinence. The long-term study, titled International multi-center evaluation of ProACT for male post prostatectomy stress urinary incontinence by Gilling, P. et al. , and abstract accepted for presentation at 23rd annual European Urology Association ( EAU ) congress, reports that 65% of patients were dry ( <1 pad a day ) at two years. In addition, patients reported a significant improvement in quality of life ( from 41. 6 before procedure to 74. 6 at two years after procedure, on a scale from 0-100 ) . Complications included erosion, migration, or non-response to initial surgery. Device removal was easily performed without adverse sequelae.

First used in 2000 in Austria by Doctor Wilhelm Hübner ( one of co-investigators in this study ) , ProACT device was implanted in 329 male patients in four international centers between 2001 and 2005. These patients suffered from incontinence arising from multiple etiologies ( but predominantly post radical prostatectomy incontinence ) . " The promising results reported here suggest that this may be an appropriate, effective and durable first-line treatment to offer men with stress urinary incontinence after prostatectomy', said Doctor Wilhelm Hübner, Director of Urology Department at Humanis Clinic in Korneuburg. Study findings will be presented at European Association of Urology ( EAU ) Annual Meeting ( March 26-29 ) in Milan, Italy. For information on this and other studies, go to http: //www. uromedica-inc. com.

ProACT™ therapy and ACT� ( Adjustable Continence Therapy ) were developed by Uromedica and approved in Europe in 2002. Based on patented technology, balloon volume can be percutaneously increased or decreased to meet the needs of individual patient. The ProACT was designed to be a first-line treatment for post-prostatectomy urinary incontinence in men, and ACT device treats stress urinary incontinence in women who have not responded to other interventions. The ProACT therapy and ACT are pending investigation in United States and aren't approved for sale by the FDA. This press release isn't intended to make any claims of safety or effectiveness in the use of these devices.

About Uromedica

Uromedica, Inc. was formed in 1997 to develop minimally invasive medical devices that treat unmet medical needs in area of urogenital and related disorders. Fourteen million people suffer from stress urinary incontinence, an embarrassing condition that produces a significant cost to society and a disturbing trend as population increases. To date, around 6000 patients have been implanted with ACT and ProACT minimally invasive devices which can be non-surgically adjusted to best meet individual patient needs. The company is in final stages of clinical studies in United States.

http: //www. uromedica-inc. com.

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May Celebrex help us?

Celebrex: uses Celebrex is a nonsteroidal anti-inflammatory drug ( NSAID ) , specifically a COX-2 inhibitor, which relieves pain and swelling ( inflammation ) . It is used to treat arthritis, acute pain, and menstrual pain and discomfort. The pain and swelling relief provided by Celebrex helps we perform more of your normal daily activities. Celebrex is also used to decrease growths found in the intestines ( colon polyps ) of persons with a family history of this condition.

Celebrex works by blocking enzyme in your body that makes prostaglandins. Decreasing prostaglandins helps to reduce pain and swelling.

Celebrex: how to use Read Medication Guide provided by your pharmacist before you start using Celebrex and each time we get a refill. If you have any questions regarding information, consult your doctor or pharmacist.

Take by mouth, usually once or twice daily, or as directed by your doctor. To decrease chance of stomach upset, Celebrex is best taken with food. Dosage is based on your medical condition and response to therapy. The lowest effective dosage should always be used, and only for prescribed length of time ( see also Warning section ) .

Take Celebrex with a full glass of water ( 8 oz or 240 ml ) unless your doctor directs you otherwise. Don't lie down for 30 minutes after taking Celebrex.

In certain conditions ( e. g. , arthritis ) , it may take up to two weeks, taken regularly, before significant benefits of Celebrex take effect.

If you are taking Celebrex on an " as needed " basis ( not on a regular schedule ) , remember that pain medications work best if they're used as first signs of pain occur. If we wait until the pain has significantly worsened, the medicine may not work as well.

Celebrex: side effects See also Warning section.

Stomach upset or gas may occur while use Celebrex. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed Celebrex because he or she has judged that the benefit to we is greater than the risk of side effects. Many people using Celebrex don't have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur:

Celebrex may rarely cause serious liver disease. If we notice any of following highly unlikely but very serious side effects, stop taking Celebrex and consult your doctor or pharmacist immediately:

In unlikely event we have a serious allergic reaction to Celebrex, seek immediate medical attention. Symptoms of a serious allergic reaction include:

This isn't a complete list of possible side effects. If we notice other effects not listed above, contact your doctor or pharmacist.

Celebrex: precautions Before taking Celebrex, tell your doctor or pharmacist if we are allergic to it; or to sulfa drugs, aspirin, other NSAIDs ( e. g. , ibuprofen ) , other COX-2 inhibitors; or if you have any other allergies.

Celebrex shouldn't be used if we have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have:

Before using Celebrex, tell your doctor or pharmacist your medical history, especially of:

This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and smoking. Consult your doctor or pharmacist for more information.

Caution is advised when using Celebrex in elderly because they may be more sensitive to the side effects of Celebrex, especially stomach bleeding and kidney effects.

Caution is advised when using Celebrex in children with a certain type of arthritis ( systemic onset juvenile rheumatoid arthritis ) because they may be at increased risk for a very serious bleeding/clotting problem ( disseminated intravascular coagulation ) . Seek immediate medical attention if your child develops sudden bleeding/bruising or bluish skin in fingers/toes.

Celebrex should be used only when clearly needed during the first 6 months of pregnancy. It shouldn't be used during last 3 months of pregnancy. Discuss risks and benefits with your doctor.

Celebrex passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding isn't recommended while using Celebrex. Consult your doctor before breast-feeding.

Celebrex: interactions Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring we for them. Don't start, stop, or change dosage of any medicine before checking with them first.

Celebrex shouldn't be used with following medication because very serious interactions may occur while use Celebrex:

If we are currently using the medication listed above, tell your doctor or pharmacist before starting Celebrex.

Before using Celebrex, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of:

Check all prescription and nonprescription medicine labels carefully for other pain/fever drugs ( NSAIDs such as aspirin, Celebrex, ibuprofen ) . These drugs are similar to Celebrex, so taking one of these drugs while also taking Celebrex may increase your risk of side effects. However, if your doctor has prescribed low doses of aspirin to prevent heart attack or stroke ( usually at dosages of 81-325 milligrams a day ) , you should continue to take aspirin. Daily use of NSAIDs ( e. g. , ibuprofen ) may decrease aspirin's ability to prevent heart attack/stroke. Consult your doctor or pharmacist for more details and to discuss other possible treatments ( e. g. , acetaminophen ) for your pain/fever.

This document doesn't contain all possible interactions. Therefore, before using Celebrex, tell your doctor or pharmacist of all products we use. Keep a list of all your medications with you, and share list with your doctor and pharmacist.

Celebrex: overdose If overdose of Celebrex is suspected, contact your local poison control center or emergency room immediately. US residents can call US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include severe stomach pain, coffee ground-like vomit, change in amount of urine, slow or shallow breathing, severe headache or loss of consciousness.

Celebrex: notes Do not share Celebrex with others.

Laboratory and/or medical tests ( e. g. , complete blood count, liver and kidney function tests ) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Non-drug treatment for arthritis that's approved by your doctor ( e. g. , weight loss if needed, strengthening and conditioning exercises ) may help improve your flexibility, range of motion, and joint function. Consult your doctor for specific instructions.

Celebrex: missed dose If we miss a dose Celebrex, use it as soon as we remember. If it's near time of the next dose, skip missed dose and resume your usual dosing schedule. Don't double dose of Celebrex to catch up.

Celebrex: storage Store Celebrex at room temperature at 77 degrees F ( 25 degrees C ) away from light and moisture. Brief storage between 59-86 degrees F ( 15-30 degrees C ) is permitted. Don't store Celebrex in bathroom. Keep all medicines away from children and pets.

Properly discard Celebrex when it's expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Celebrex: warning Rarely, Celebrex can cause serious ( very rarely fatal ) stomach/intestinal bleeding. Also, Celebrex and related drugs have rarely caused blood clots to form, resulting in possibly fatal heart attacks and strokes. Talk to your doctor or pharmacist about the benefits and risks of treatment, as well as other medication choices.

If we notice any of these rare but very serious side effects, stop taking Celebrex and seek immediate medical attention: coffee-ground vomit, black stools, persistent stomach/abdominal pain, chest pain, weakness on one side of body, slurred speech, sudden vision changes.

Celebrex should not be used right before or after heart bypass surgery.

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