Clinical Trials On Gemtesa
FDA approval of GEMTESA was based on a 12-week, double-blind, randomised, placebo-controlled, and active-controlled clinical trial named EMPOWUR.
A total of 1,515 OAB patients were randomised in 5:5:4 ratio to receive either GEMTESA 75mg , placebo or active control orally once daily for 12 weeks.
The patients with signs of OAB for at least three months with an average of eight or more micturitions a day and at least one UUI a day, or an average of eight or more micturitions a day and at least three urgency episodes a day were eligible to enter the trial.
The study population included OAB opioid-naive patients, as well as patients who had undergone previous OAB drug therapy.
The co-primary endpoints of the trial were changes in micturition frequency and UUI episodes at week 12.
At 12 weeks, micturition reduced by an adjusted mean of 1.8 episodes a day in patients receiving GEMTESA compared to 1.3 episodes a day for placebo and 1.6 episodes a day for tolterodine.
In incontinent patients, urge incontinence episodes decreased by an adjusted mean of two episodes a day for GEMTESA versus 1.4 for placebo and 1.8 for tolterodine.
GEMTESA was also substantially superior to placebo for secondary endpoints including the number of urgency episodes, volume per urination, and proportion of incontinent patients with a 75% or higher reduction in the urge incontinence episode.
Overactive Bladder Causes And Symptoms
Overactive bladder is a clinical condition that happens when the muscles of the bladder contract involuntarily. When the bladder muscle contracts too frequently or at the wrong time, the person might have signs of an OAB.
The condition is marked by a sudden need to urinate that is difficult to manage with or without accidental urinary discharge and typically with elevated urinary frequency. Unintentional urinary leakage due to urgency is referred to as UUI. Excessive urination and nocturnal symptoms are some of the other symptoms of OAB.
More than 30 million people in the US suffer from troubling symptoms of OAB, which can significantly hamper the day-to-day activities of the patients.
Types Of Urinary Incontinence
There are different types of incontinence:
- Stress incontinence occurs when urine leaks as pressure is put on the bladder, for example, during exercise, coughing, sneezing, laughing, or lifting heavy objects. Its the most common type of bladder control problem in younger and middle-age women. It may begin around the time of menopause.
- Urge incontinence happens when people have a sudden need to urinate and cannot hold their urine long enough to get to the toilet. It may be a problem for people who have diabetes, Alzheimers disease, Parkinsons disease, multiple sclerosis, or stroke.
- Overflow incontinence happens when small amounts of urine leak from a bladder that is always full. A man can have trouble emptying his bladder if an enlarged prostate is blocking the urethra. Diabetes and spinal cord injuries can also cause this type of incontinence.
- Functional incontinence occurs in many older people who have normal bladder control. They just have a problem getting to the toilet because of arthritis or other disorders that make it hard to move quickly.
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Medication For Incontinence In The Elderly
Anticholinergics. These medications can calm an overactive bladder and may be helpful for urge incontinence. Examples include oxybutynin , tolterodine , darifenacin , fesoterodine , solifenacin and trospium chloride. Mirabegron .Mar 9, 2021
Urinary incontinence medications for elderly
- TREATMENT OF URGE INCONTINENCE. The anticholinergic agents oxybutynin and tolterodine are used widely to treat urge incontinence. These medications are not, however, the most effective therapies. Behavior therapies are more effective, and theynot medicationsshould be first-line treatment.
Medication for incontinence in the elderly Medications are frequently used in combination with behavioral therapies. Here are some commonly prescribed options: Anticholinergic or antispasmodic drugs
A Mans Guide To Overactive Bladder
Incontinence and overactive bladder can be potentially embarrassing conditions for men. Before using meds, find out about alternate therapies for relief.
They are problems that many men dont want to talk about out of potential embarrassment. Still, many men have to contend with overactive bladder and urinary incontinence in laymans terms, when control over urination is lost which can be an indication of bigger problems. Just as important, it can lead to emotional issues and impact a mans social life.
There are treatment options available for the condition, though many doctors will first turn to prescription medication, especially if the leakage is the result of an overactive bladder. Drugs such as Ditropan XL , Detrol , VESIcare , Avodart and Flomax are just some of the ones used. But did you known that there are a host of side effects that are associated with them?
If taking medication doesnt sound like a great prospect to you and the possibility of wearing pads makes you anxious, dont panic. The good news is there are plenty of non-pharmacological treatments available that have good outcomes with fewer side effects. One of them is even a simple exercise you can do at home.
But before we get into treatments, lets start with a primer on urinary incontinence and what could put you at risk for suffering from it.
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Fda Approves New Drug For Uti Two Devices For Oab/incontinence
The FDA approved cefiderocol in patients 18 years of age or older who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections , including pyelonephritis, caused by the following: susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex.
The approval of cefiderocol is based on data from the pivotal APEKS-cUTI study, a multinational, multicenter, double-blind clinical trial that evaluated the drugs efficacy and safety versus imipenem/cilastatin in patients with cUTI, according to a statement from Shionogi & Co., Ltd., the drugs manufacturer. Study results showed the response rates for the composite endpoint of microbiological eradication and clinical response at the test of cure were significantly higher in the cefiderocol arm compared to the IPM/CS arm.
In the study, 72.6% of patients in the cefiderocol arm met the primary endpoint versus 54.6% in the IPM/CS arm at TOC. The adjusted difference between the groups was 18.58% . Clinical response rates at the TOC visit were similar between cefiderocol and IPM/CS.
Serious adverse events were reported for 4.7% of patients who received cefiderocol and 8.1% of patients who received IPM/CS.
Shionogi said it anticipates making the drug commercially available in early 2020.
Botulinum Toxin Injections For Oab
To treat incontinence, doctors inject botulinum toxininto the bladder muscle. This is done with a needle that is inserted via a long tube called a cystoscope that goes up into the bladder. “The goal is to reduce the over-activity of the bladder muscle so that the patient has better control, but still allow enough muscle contraction to empty the bladder,” Rames says. The effects generally last for about 9 months. So far there don’t seem to be any major side effects from botulinum toxin, although it’s only recommended if your symptoms aren’t controlled with behavioral therapies, medications, or a combination of both.
Linda Brubaker, MD, professor, department of obstetrics & gynecology and urology, Loyola University Chicago Stritch School of Medicine, Chicago.
Ross Rames, MD, associate professor of urology, Medical University of South Carolina, Charleston.
UpToDate: “Treatment of Urinary Incontinence.”
National Association for Continence: “Overactive Bladder Treatment.”
Duthie JB. Cochrane Summaries, Dec. 7, 2011.
National Association for Continence: “Urgency Urinary Incontinence/Overactive Bladder.”
News release, FDA.
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‘clear Need For New Drugs’
Urologist Elizabeth Kavaler, MD, of Lenox Hill Hospital in New York City, says there is a clear need for new types of drugs that work in new ways to treat overactive bladder.
She says the previously approved prescription medications available in the U.S. all work in the same way.
“These drugs are very effective — around 90% of patients who take them respond,” she tells WebMD. “The problem is that many patients find they can’t or don’t want to take these drugs.”
She says that’s because of common side effects that include:
Kavaler recommends that people with overactive bladder first try making changes in behavior. These changes can include limiting or eliminating bladder irritants such as:
People with OAB can also reduce drinking all fluids and practice Kegel exercises to strengthen pelvic muscles.
If these lifestyle changes do not improve symptoms, medication may be needed, she says.
Kavaler says Myrbetriq may prove to be easier to tolerate for patients who either can’t take the previously available drugs or who find the side effects intolerable.
“Clearly, we have a huge need in this area, as evidenced by the fact that so many companies are marketing what is essentially the same drug,” she says. “It will be nice to have something different to offer.”
Defining The Medical Need: Tolerability
Safety and tolerability are key considerations in the treatment of non-life-threatening disorders, such as OAB. Although muscarinic receptor antagonists are generally considered to be well tolerated, AEs are one of the leading causes of discontinuation. The most frequently observed AE in patients receiving treatment with a muscarinic receptor antagonist is dry mouth. Other relevant AEs include constipation, increases in heart rate and impairments of central nervous system functions. Among the latter, impaired cognition probably is the most important, but impaired sleep is also relevant. Although the reported incidence of impaired cognition is low in most studies, this probably represents an underestimation, because most studies of muscarinic antagonists were not designed to systematically capture such events and/or were underpowered for meaningful results. Furthermore, many medications unrelated to OAB, but potentially present in such patients as comedications, also have antimuscarinic effects. These include anti-allergic, anti-emetic, obstructive airway and gastrointestinal drugs, as well as those targeting central nervous disease, such as anti-Parkinson and psychopharmacological medications. Therefore, the full impact of muscarinic antagonists on central nervous function can only be appreciated when the total antimuscarinic load is considered.
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Overactive Bladder In The Vulnerable Elderly
Accepted for publication 26 June 2014
3 October 2014Volume 2014:6 Pages 131138
Urinary symptoms such as urgency/frequency and incontinence become increasingly prevalent with aging.1,2 A large multinational population-based survey estimated the prevalence of overactive bladder in Europe and Canada to be 12.8% in women and 10.8% in men.2 The NOBLE study showed similar trends in the USA, with OAB being twice as prevalent in individuals over 65 years of age than in those aged 45 years or younger.3 Urinary symptoms have a considerable negative impact on quality of life and health in the elderly,4,5 and have been shown to be associated with increased risk of falls and fractures.6,7 Costs associated with urinary symptoms in the aged are significant.8,9 With the aging of the population, it is estimated that by 2025 there will be 52 million adults in the USA with lower urinary tract symptoms.10 Thus, the burden of these symptoms on society is increasing.
Vulnerable or frail elderly
Evaluating OAB in the vulnerable elderly
Figure 1 Conceptual relationship of clinical factors.Notes: Symptoms, measurable function, and morbidity related pathophysiology, their evaluation and any treatments are related concerns which must be identified, clarified, and prioritized. While this sometimes-subtle distinction is always important, it assumes greater importance in the vulnerable elderly.
Who is the patient?
What are feasible treatment options?
What Causes Interstitial Cystitis
In some people with the condition, the bladder is inflamed, ulcerated, scarred or stiff.
There are several theories about the possible cause of the condition.
- damage to the bladder lining, which may mean pee can irritate the bladder and surrounding muscles and nerves
- a problem with the pelvic floor muscles used to control peeing
- your immune system mistakenly attacking your bladder
- an allergic reaction
Its also been suggested that interstitial cystitis may be a symptom of a more widespread problem, as its been associated with conditions such as fibromyalgia, chronic fatigue syndrome , irritable bowel syndrome and lupus.
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How To Cope With Side Effects
What to do about:
- feeling sick â try taking mirabegron with a meal or snack. It may also help if you stick to simple meals and avoid rich or spicy food.
- constipation â eat more high-fibre foodsâ¯such as fresh fruit, vegetables and cereals, and drink plenty of water.â¯Try to exercise more regularly, for example, by going for a daily walk or run. If this does not help, talk to your pharmacist or doctor.â¯Watch this short video about how to treat constipation.
- diarrhoea â drink lots of fluids, such as water or squash, to avoid dehydration. Signs of dehydration include peeing less than usual or having dark strong-smelling pee. Do not take any other medicines to treat diarrhoea without speaking to a pharmacist or doctor.
- urinary tract infection â if you think you have a UTI, ask a pharmacist or doctor to recommend a treatment. Tell them that you are taking mirabegron.
- headache â make sure you rest and drink plenty of fluids. Do not drink too much alcohol. Ask a pharmacist to recommend a painkiller. Talk to your doctor if the headaches continue or are severe.
- feeling dizzy â stop what you’re doing and sit or lie down until you feel better. Do not drive, ride a bike or operate machinery until it passes. If you are still having dizzy spells after a week, speak to your doctor.
- fast heart rate â lie down and try to relax. This is usually nothing to worry about and will pass. Contact 111 if your heart beat does not slow down after resting, or if you have chest pain.
What Behavioral Changes Can I Make To Help With Overactive Bladder
There are many techniques and changes to your typical behavior that you can try to help with an overactive bladder. These can include:
Keeping a log: During a typical day, write down your fluid intake, the number of times you urinate, the number of accidents and when they occur. Make a note about what happened when the accident happened, like when you:
- Were unable to reach the bathroom in time.
Monitoring your diet: Eliminate or decrease foods or beverages that may worsen your bladder symptoms. These could include:
- Spicy and acidic foods and drinks.
- Foods and drinks that contain artificial sweeteners.
Maintaining bowel regularity: Constipation can place added pressure on the bladder and have a negative effect on your bladder function. By keeping healthy bowel habits, you may be able to avoid constipation and help to lessen bladder symptoms. The following are some suggestions for maintaining bowel regularity:
- Increase your fiber intake by eating foods like beans, pasta, oatmeal, bran cereal, whole wheat bread, and fresh fruit and vegetables.
- Every morning, take 2 tablespoons of this mixture: 1 cup apple sauce, 1 cup unprocessed wheat bran, and Â¾ cup prune juice.
- Exercise regularly to maintain regular bowel movements.
Maintaining a healthy weight: Being overweight can add pressure on your bladder, which may contribute to bladder control problems. If you are overweight, weight loss can reduce the pressure on your bladder.
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Overcoming Barriers To Treatment
Dr. Slopnick says there are a number of reasons why people with overactive bladder problems dont explore all treatment options.
Most of the time, its two or three years before people are diagnosed or even have treatment, she says. Then, after patients try multiple medications without success, they may lose hope for an effective treatment and give up.
But theres no reason to prolong treatment thats not working, she says.
She suggests talking to a urologist after your first failed attempt at treatment with medication. The main point is that if youre having bothersome symptoms, talk to your doctor about them, she says.
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Can Incontinence Be Prevented
Different events throughout your life can lead to many of the things that cause incontinence. The muscles that support your pelvic organs can weaken over time. For women, these muscles can also be weakened by big life events like pregnancy and childbirth. However, in the same way you work out to build strength in your legs or arms, you can do exercises to strengthen your pelvic floor muscles. Doing exercises to strengthen your pelvic muscles may not prevent you from having any issues with incontinence, but it can help you regain control of your bladder. Maintaining a healthy body weight can also help with bladder control. Talk to your healthcare provider about the best ways to maintain strong pelvic floor muscles throughout your life.
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Prescription Drugs For Overactive Bladder
There are several prescription drugs for overactive bladder .
The FDA approved medications, or drugs, currently available on the U.S. market for the treatment of urinary incontinence are for a specific condition called overactive bladder . Some are also used for OAB with urge urinary incontinence . You may have seen advertisements on television or in magazines for these medications. Most of the prescription drugs for OAB partially calm the bladder muscles that cause abnormal contractions, thereby reducing the frequency and severity of the overwhelming urge to urinate. Some of these drugs may also increase the bladders capacity to hold urine and delay the initial urge to void. This class of drugs is referred to as antimuscarinics.
The currently FDA approved antimuscarinic drugs for OAB are: Oxybutynin, Tolterodine, Solifenacin, Hyoscyamine, and Darifenacin. These drugs are sold under the names of: Ditropan, Detrol, Vesicare, Enablex, Levbid, Cytospaz and Oxytrol. Most of these are oral medications and need a doctors prescription. Only one drug will be available over-the-counter as of September 2013, and it is in a skin patch form for women only.
Note: Drugs that are currently approved may be suddenly taken off the market, and new drugs are being introduced. Your healthcare provider and pharmacist can help you know which current drugs on the market may be the best for your circumstances.
Who May Need a Prescription?
Possible Side Effects
Key Points to Remember