What is Botox®?
Botox® is Botulinum Toxin A produced by the bacteria Clostridium Botulinum.
What is used for?
Botox® has been used widely to treat a number of conditions including facial wrinkles, muscle spasms and more recently the overactive bladder. Injection into the bladder wall can partially paralyse the bladder, inhibiting involuntary bladder contractions and treating urinary urgency and urge incontinence. Botox® is approved by the Therapeutic Goods Administration for use in neurogenic and non-neurogenic overactive bladder in Australia.
How does Botox® work?
Botox® works by blocking the release of neurotransmitters (chemicals) at nerve endings. Neurotransmitters are the chemicals released by nerves in order for nerves to function. Botox® causes a localized partial and reversible denervation (loss of nerve supply) to the muscle at the site it is injected resulting in an area of localized muscle paralysis. The effect is not permanent because eventually the nerve endings sprout and grow to re innervate that muscle.
What is done?
Injections into the bladder are done via a cystoscope (telescope) inserted into the urethra. The procedure takes about 15 minutes and can be done as day surgery under general anaesthesia, sedation or local anaesthesia.
What are the alternatives?
For urge incontinence there are other treatments including pelvic floor exercises, bladder training, neurostimualtion and anticholinergic medications such as Ditropan, Amitripylline, Detrusitol, Vesicare, Oxytrol or Betmiga. Other options are sacral neuromodulation, percutaneous tibial nerve stimulation or augmentation cystoplasty.
What tests are usually required beforehand?
A urine test to exclude infection and Fluoroscopic Urodynamic studies. Botox® injections are used in patients who have failed non-surgical treatment options.
Will it work and for how long?
The effect of Botox® is temporary. Injection in the bladder lasts about 9 months (6-12 months). Some patients may not respond to the treatment.
Will the injection work immediately?
It may take 2-4 days to work and the maximum effect may take up to 7 days to occur.
Paralysis of the bladder may result in transient urinary retention – an inability to pass urine. If this occurs you will be taught pass a catheter so you can empty the bladder as required. If retention occurs may take 3 weeks to 3 months to resolve or longer, but usually it resolves within a few weeks.
Patients may also experience;
- Localised pain at the injection site
- Malaise (mild transient flu-like illness) lasting up to six weeks after injection.
- Transient blood in the urine. There is a small risk of troublesome bleeding. Drugs like aspirin, warfarin, clopidogrel or other blood thinners may need to be stopped 3-7 days prior to surgery, as advised, but often there is no need.
- There is a small risk of a urine infection following the procedure.
- Skin rash, itching and allergic reactions have been reported rarely.
- There have been isolated reports of generalized muscle weakness or pain.
- There have been rare reports when injected at sites other than the bladder of difficulty swallowing, pneumonia, heart arrhythmia, heart attack and even death.
- Surgery and general anaesthesia carries some general medical risks including Deep Vein Thrombosis (blood clots in deep leg veins), Pulmonary Embolus (these clots dislodging and going to the lungs), pneumonia, heart attack and stroke.
It is often not possible to warn patients of every possible risk or potential complication with surgery especially if very rare. Yet it is important that you are aware of what risks are involved, especially the more common ones. This information is not meant to alarm you but allow you to make an informed consent to have surgery. It is very rare but unfortunately some patients can suffer complications and end up worse off as a result of their surgery.
Botox® should not be used in patients with;
- Myasthenia Gravis, Eaton Lambert Syndrome or Amyotropic Lateral Sclerosis
- Known hypersensitivity to and ingredient in the formulation
- In the presence of urine infection
- In conjunction with aminoglycoside antibiotics e.g. gentamicin or other drugs that interfere with neuromuscular transmission.
- During pregnancy or breast feeding.
- Haemophilia or other bleeding disorders
The Botox® preparations contains albumin, a derivative of human blood.
Based on effective donor screening and product manufacturing processes, it carries and extremely remote risk of transmission of viral diseases or Creutzfeldt-Jacob disease. No cases of transmission of viral diseases have ever been identified for albumin. It may not be suitable for people who are a Jehovah’s witness.
Can it be repeated?
Yes, after 3 months at the earliest. About 5% of patients lose their response to Botox® over time because they develop antibodies to the Botox®. This is more likely if injection treatments are given more frequently than every 2-3 months. Currently there is no evidence that repeated injections causes damage to the bladder but this is a new treatment and the long term effects of repeated injections is not fully investigated.
You will be given a follow up appointment. If you experience any of the following problems you should seek medical attention;
- Symptoms of a urine infection
- Severe pain not controlled with pain killers
- Inability to pass a catheter if required
- Or any other significant trouble.
If you are taking anticholinergic medication and the treatment is effective you should be able to stop this 2-3 days after surgery.
Version: V3, July 2017