WHAT IS OVERACTIVE BLADDER?
Overactive Bladder (OAB) is a common, sometimes disabling condition often associated with a considerable impact on patients.1 An estimated 39 million Americans currently have OAB.2 Overactive bladder is a urological condition. The hallmark symptom of OAB is urgency to urinate, but other symptoms are included in the diagnosis: urinary frequency, with or without urgency urinary incontinence.3
WHAT CAUSES OVERACTIVE BLADDER?
OAB occurs when nerves are affected (or damaged),4 and:
- Send signals to the bladder at the wrong time, causing the muscle to squeeze without warning;
- Cause the bladder to spasm uncontrollably, creating leakage, the strong sudden need to "go," and going too often.
HOW IS OVERACTIVE BLADDER TREATED?
Often times, treatment begins with lifestyle changes, such as reduction of fluid intake, decreased amounts of caffeine, bladder control strategies and pelvic floor muscle training.3
Oral anticholinergic medications are often prescribed by physicians to manage OAB in adults.3 However, in one study of 1,117 patients, 73.5 percent stopped taking their OAB therapy within one year.5 According to two separate surveys, the top reasons OAB patients discontinue anticholinergics are poor tolerability and/or lack of efficacy.6,7
There are treatment options beyond pills. BOTOX® (onabotulinumtoxinA) treatment was approved in January 2013 to treat overactive bladder symptoms, such as a strong need to urinate with leakage, urgency and frequency in adults when another type of medication (anticholinergic) does not work well enough or cannot be taken.
Other treatment options may include surgery (e.g., a peripheral or surgically-implanted neuromodulation device, or bladder augmentation surgery).4
HOW DOES BOTOX® WORK?
BOTOX® is a different treatment option that takes another approach to targeting the source of OAB: the bladder muscle itself. In the body, certain chemicals travel from nerve cells to muscle cells to make the bladder contract so one can urinate. With OAB, these muscles contract uncontrollably and the person frequently feels like they have to empty their bladder.4
BOTOX® treatment works by calming the nerves that trigger the overactive bladder muscle, helping to:
- Reduce daily leakage episodes;
- Treat the strong need to urinate right away;
- Reduce the number of times needed to empty the bladder daily.
WHAT CAN OAB PATIENTS EXPECT WITH BOTOX®?
The following results were reported in two 24-week studies after patients received BOTOX® treatment for their OAB. By week 12:8
- About three times fewer accidents were experienced by patients who received BOTOX® than those who did not.
- On average, people who received BOTOX® reduced their bathroom visits by two times a day.
- The amount people urinated was increased by an average of about 25 percent per bathroom visit.
One BOTOX® treatment can last up to 6 months before the effects wear off.8 Patients should be considered for re-injection when the clinical effect of the previous injection diminishes, but no sooner than 12 weeks from the prior bladder injection.
WHAT ARE THE SIDE EFFECTS ASSOCIATED WITH BOTOX® TREATMENT?
The most common adverse reactions with BOTOX® treatment are urinary tract infections (UTI) (18 percent vs. 6 percent in placebo), dysuria (painful or difficult urination) (9 percent vs. 7 percent in placebo), and urinary retention (temporary inability to fully empty the bladder following treatment) (6 percent vs. 0 percent in placebo).8 This is not a complete list of side effects. Patients should see the Important Safety Information and talk to their doctor about any concerns they may have.
If a patient experiences retention, they can use a disposable self-catheter to drain the urine until the bladder starts emptying normally again.9 Unlike a larger hospital catheter, this catheter is about the size of a thin, short straw, like a coffee stirrer, fits in a handbag, and can be used in any bathroom.8,9 The catheter is inserted when the patient needs to drain urine and then it is removed after use.10,11 Retention is not a permanent condition and one’s doctor can advise on how long it may last.8 In general, adverse reactions occur within the first week following injection of BOTOX® and, while generally transient, may have a duration of several months or longer.8
HOW ARE OAB PATIENTS TREATED WITH BOTOX®?
BOTOX® should be given by a qualified urologist or urogynecologist who has been trained to administer the treatment. Patients should not receive BOTOX® if they have a urinary tract infection. Patients will be given a preventative antibiotic to help prevent infection. For patient comfort, a local anesthetic may be administered as a numbing agent and patients may also be provided with a sedative, all of which can be performed in a qualified specialist’s office.
Once the bladder is numb, BOTOX® is injected into the bladder muscle using a cystoscope, a specialized tube with an optical lens at the end that is used to see inside the bladder. A cystoscope is placed into the bladder via the urethra, the natural opening where urine comes out.
BOTOX® then goes through the cystoscope and is administered with a small needle into multiple areas of the bladder muscle. The treatment takes approximately 20-30 minutes (20 injections) to administer and then the patient is observed for about 30 minutes to ensure that the patient can empty the bladder before he/she leaves the office.
For patients with OAB, treatment with BOTOX® could take up to one hour in the urologist or urogynecologist’s office two times a year.8
Patients should be considered for re-injection when the clinical effect of the previous injection diminishes, but no sooner than 12 weeks from the prior bladder injection.
BOTOX® (onabotulinumtoxinA) & BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
BOTOX® is a prescription medicine that is injected into muscles and used:
- to treat overactive bladder symptoms such as a strong need to urinate with leaking or wetting accidents (urge urinary incontinence), a strong need to urinate right away (urgency), and urinating often (frequency) in adults 18 years and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken.
- to treat leakage of urine (incontinence) in adults 18 years and older with overactive bladder due to neurologic disease who still have leakage or cannot tolerate the side effects after trying an anticholinergic medication
- to prevent headaches in adults with chronic migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years or older
- to treat increased muscle stiffness in elbow, wrist, and finger muscles in people 18 years and older with upper limb spasticity
- to treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in people 16 years and older
- to treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years and older
BOTOX® is also injected into the skin to treat the symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough in people 18 years and older.
BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults younger than 65 years of age for a short period of time (temporary).
BOTOX® Cosmetic is a prescription medicine that is injected into the area around the side of the eyes to improve the look of moderate to severe crow’s feet lines in adults for a short period of time (temporary).
It is not known whether BOTOX® and BOTOX® Cosmetic are safe or effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine).
It is not known whether BOTOX® is safe or effective to treat increased stiffness in upper-limb muscles other than those in the elbow, wrist, and fingers, or to treat increased stiffness in lower-limb muscles. BOTOX® has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles. Treatment with BOTOX® is not meant to replace your existing physical therapy or other rehabilitation that your doctor may have prescribed.
It is not known whether BOTOX® and BOTOX® Cosmetic are safe or effective for severe sweating anywhere other than your armpits.
IMPORTANT SAFETY INFORMATION BOTOX® and BOTOX® Cosmetic 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® or BOTOX® Cosmetic:
- 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
There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX® has been used at the recommended dose to treat chronic migraine, severe underarm sweating, blepharospasm, strabismus, or when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines or crow’s feet lines.
Do not take BOTOX® or BOTOX® Cosmetic 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.
Due to the risk of urinary retention (not being able to empty the bladder), only patients who are willing and able to initiate catheterization post-treatment, if required, should be considered for treatment.
Patients treated for overactive bladder
In clinical trials, 6.5% of patients (36/552) initiated clean intermittent catheterization for urinary retention following treatment with BOTOX® 100 Units as compared to 0.4% of patients (2/542) treated with placebo. The median duration of catheterization for these patients treated with BOTOX® 100 Units was 63 days (minimum 1 day to maximum 214 days) as compared to a median duration 11 days (minimum 3 days to maximum 18 days) for patients receiving placebo.
Patients with diabetes mellitus treated with BOTOX® were more likely to develop urinary retention than non-diabetics.
Patients treated for overactive bladder due to neurologic disease
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.
The dose of BOTOX® and BOTOX® Cosmetic is not the same as, or comparable to, any other 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® or BOTOX® Cosmetic 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® or BOTOX® Cosmetic.
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 upper limb spasticity or 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®.
Cornea problems have been reported. Cornea (surface of the eye) problems have been reported in some people receiving BOTOX® for their blepharospasm, especially in people with certain nerve disorders. BOTOX® may cause the eyelids to blink less, which could lead to the surface of the eye being exposed to air more than is usual. Tell your doctor if you experience any problems with your eyes while receiving BOTOX®. Your doctor may treat your eyes with drops, ointments, contact lenses, or with an eye patch.
Bleeding behind the eye has been reported. Bleeding behind the eyeball has been reported in some people receiving BOTOX® for their strabismus. Tell your doctor if you notice any new visual problems while receiving BOTOX®.
Bronchitis and upper respiratory tract infections (common colds) have been reported. Bronchitis was reported more frequently in people receiving BOTOX® for their upper limb spasticity. Upper respiratory infections (common colds) were also reported more frequently in people with prior breathing-related problems.
Autonomic dysreflexia in patients treated for overactive bladder due to neurologic disease
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).
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® or BOTOX® Cosmetic can harm your unborn baby); are breastfeeding or plan to breastfeed (it is not known if BOTOX® or BOTOX® Cosmetic passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. Using BOTOX® or BOTOX® Cosmetic 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® or BOTOX® Cosmetic 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
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 anti¬coagulants (blood thinners).
Other side effects of BOTOX® and BOTOX® Cosmetic 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. In people being treated for urinary incontinence other side effects include: urinary tract infection, painful urination, and/or inability to empty your bladder on your own. If you have difficulty fully emptying your bladder after receiving BOTOX®, you may need to use disposable self-catheters to empty your bladder up to a few times each day until your bladder is able to start emptying again.
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.
Please see BOTOX® Cosmetic full Product Information including Boxed Warning and Medication Guide.