From the Guidelines
Yes, both onabotulinumtoxinA (Botox) and sacral neuromodulation are FDA-approved treatments for overactive bladder. According to the most recent guideline, onabotulinumtoxinA (Botox) and sacral neuromodulation are recommended as treatment options for patients with overactive bladder who have an inadequate response to, or have experienced intolerable side effects from, pharmacotherapy or behavioral therapy 1. The treatment effects of Botox generally last 6-9 months, after which retreatment may be necessary, while sacral neuromodulation involves implanting a small device that delivers mild electrical impulses to the sacral nerves that control bladder function. Key considerations for these treatments include:
- Patient preference
- Comorbidities
- Physician expertise
- Potential side effects, such as urinary retention with Botox, as noted in previous studies 1. However, the most recent guideline 1 provides the strongest evidence for the use of these treatments in clinical practice.
From the FDA Drug Label
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 when another type of medicine (anticholinergic) does not work well enough or cannot be taken to treat leakage of urine (incontinence) in adults with overactive bladder due to neurologic disease when another type of medicine (anticholinergic) does not work well enough or cannot be taken.
The FDA drug label for onabotulinumtoxinA (Botox) indicates that it is FDA-approved for the treatment of overactive bladder symptoms. However, there is no information in the provided drug label about sacral neuromodulation.
- OnabotulinumtoxinA (Botox) is FDA-approved for overactive bladder treatment.
- There is no information about sacral neuromodulation in the provided label 2.
From the Research
FDA Approval Status
- OnabotulinumtoxinA (Botox) and sacral neuromodulation are both considered for the treatment of overactive bladder.
- According to the studies, sacral neuromodulation has FDA approval for use in OAB patients 3, 4, 5.
- OnabotulinumtoxinA (Botox) also has FDA approval for use in OAB patients, as mentioned in 3.
- However, an earlier study in 2010 stated that only sacral neuromodulation with InterStimTM therapy had FDA approval for use in OAB patients at that time 4.
- It can be inferred that both treatments have been approved by the FDA for the treatment of overactive bladder, with sacral neuromodulation being approved earlier 3, 5.
Treatment Options
- Sacral neuromodulation and onabotulinumtoxinA (Botox) are minimally invasive and reversible alternatives for the treatment of refractory overactive bladder 3, 4.
- Both treatments have been shown to be effective in improving symptoms of overactive bladder, with varying side-effect profiles 6, 3, 5.
- The choice of treatment may depend on individual patient characteristics and preferences, as well as the severity of symptoms 7.