Overactive bladder (OAB) is a condition where bladder muscles squeeze too often, even when your bladder is not full. Some people with OAB may have the following symptoms:
- Sudden, urgent need to pee (urinary urgency)
- Leaking pee (urine incontinence)
- Need to pee more often (frequent urination)
- Waking up at least two times per night to pee (nocturia)
OAB is commonly treated with a class of medicines called anticholinergics or antimuscarinics. These medicines block chemicals in your body that help the bladder to squeeze. By blocking these chemicals, the bladder muscle relaxes and can hold more pee. However, these medicines cause common side effects, like dry mouth, constipation, and memory problems, that limit their use.
Beta-3 adrenergic receptor agonists, like Gemtesa, are newer medicines that are used as alternatives when the anticholinergics or antimuscarinic medicines are not effective or cause side effects that cannot be tolerated. They relax the bladder muscle in a different way to increase the amount of pee the bladder can hold and reduce the urgent need to go pee. These medicines have less side effects and are only taken once daily.
How Does Gemtesa Work?
Gemtesa works directly on the beta-3 adrenergic receptors in the bladder muscle. Receptors are like doors that require a chemical “key” to open them and make reactions happen in the body. Gemtesa is a key for the beta-3 receptors, which allow the bladder muscle to relax and stop squeezing so much. This allows you to hold more pee and decreases the urge to go so often.
How Should I Take Gemtesa?
Gemtesa is an oral tablet taken daily. The tablet is swallowed whole with a full glass of water. It can also be crushed and mixed with 1 tablespoon of applesauce and taken with a full glass of water. It is important to take it as prescribed by your health care provider.
How Was Gemtesa Studied?
The efficacy of Gemtesa was studied in a 12-week, placebo-controlled study called EMPOWUR. Placebo-controlled studies help researchers see differences in benefit or harm of a medicine when compared to no treatment (placebo). Efficacy was defined as a change in urinary frequency and number of urgency incontinence episodes.
Each person took a 7-day survey at weeks 1 and 3 before starting the study and at weeks 2, 4, 8, 12 of the study. The survey included the following information about their OAB symptoms.
- Number of times the person had to urinate each day
- Number of times the person had urine incontinence
- Number of urgent urinations
Everyone had symptoms of OAB (urinary urgency, frequency, and incontinence) for at least 3 months. They were either newly treated with study medicine or had failed other treatments for OAB prior to starting the study. Most of the people in the study were White (78%) and female (85%), with an average age of 60. On average, those in the study had to pee 12 times per day, had four incontinent episodes, and had eight urgency episodes.
What Benefits Were Seen in the Study?
People who used Gemtesa saw the following improvements in their OAB symptoms compared to the people who used placebo. These symptoms included the number of urinations (peeing), urine leaks, and the urgent need to urinate.
Gemtesa | Placebo | |
Urinations each day | ⇓ 1.8 | ⇓ 1.3 |
Urine incontinent (leaks) each day | ⇓ 2.0 | ⇓ 1.4 |
Urgent urinations each day | ⇓ 2.7 | ⇓ 2 |
Almost half of the people (48%) using Gemtesa saw a 75% decrease in the number of incontinent episodes. One quarter of the people had no incontinent episodes. This could lead to a better quality of life with no or reduced leaks.
Your results may differ from what was seen in clinical studies. You and your health care provider should determine if the benefits outweigh any potential risks.
What Are the Signs That Gemtesa Is Working?
It could take up to 3 months to see improvement in your OAB symptoms. However, some people may see improvement in a few weeks. You may notice fewer trips to the bathroom, less leaks, less time peeing at night, and more time between the urge to pee to making it to the bathroom without leaking.
It is important for you to track the following signs of changes and review with your health care provider.
- Number of times going to the bathroom each day
- Number of leaks, changes in pads or underwear each day
- Time between urges and going to the bathroom
- Number of times you wake up and need to go to the bathroom each night
How Can I Prevent and Manage Side Effects?
The most common side effects are headache, nausea, and diarrhea. You may see more infections, like common colds, the flu, or kidney or bladder infections. The best way to prevent infection is to reduce your exposure to germs by washing your hands and avoiding people who are sick.
Some people may experience urinary hesitancy or retention, where it is difficult to pee or hard to completely empty the bladder. This can lead to infections or other kidney and bladder issues. People may be at a higher risk if they have issues or health conditions that make it more difficult to pee, like benign prostatic hyperplasia (BPH) or taking a medication that causes similar side effects. Talk with your health care provider if you have the following symptoms of urinary hesitation or retention:
- Hard time starting to pee or maintaining the stream
- Dribbling pee
- Low back pain
- Swelling of the lower abdomen
- Nausea or vomiting
- Chills or shaking
These are not all of the possible side effects. Talk with your health care provider if you are having symptoms that bother you. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What Types of Drug Interactions Can Happen?
Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vaccines, vitamins/minerals, herbal products, and other supplements you are using. Make sure that you discuss if you are using any or have had any of the following before taking and after stopping treatment.
Gemtesa may increase the blood levels of digoxin, a medicine commonly used to treat heart conditions. If digoxin levels are too high, you may have side effects. Your health care provider will check blood levels of digoxin before starting Gemtesa and during treatment. Talk with your health care provider if you have any of the following symptoms of high digoxin levels:
- Slow or irregular heartbeat
- Dizziness or confusion
- Tiredness
- Blurry vision
- Headache
- Nausea, vomiting, or diarrhea
This is not a complete list of medicines that may interact with Gemtesa. Tell your pharmacist or health care provider about all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken. This will help them determine if there are any interactions or if you need a dosage adjustment.
Is There a Cost Assistance Program?
There is a copay assistance program from the manufacturer that lowers the cost of your prescription. Whether you are eligible depends on if you have prescription insurance and what type of insurance you have. You can find out more gemtesa.com/savings-and-pricing, texting GEMTESA to 436872, or by calling 833-876-8268.
