Bladder > Bladder Treatments > Botulinum Toxin

Botulinum Toxin

Botulinum toxin is a powerful neurotoxin made by a bacterium Clostridium botulinum. It works by blocking the transmission of the electrical impulse from a nerve which makes a muscle contract. Thus injecting Botulinum toxin into a muscle causes muscle paralysis. The blockade is permanent and recovery is dependant on the cells making new receptors, a process that takes around 12 weeks. This is why, when used cosmetically, the effects of botulinum toxin wear off at around 3 months.

Botulinum toxin is currently unlicensed for non neurogenic detrusor overactivity, and as such may not be funded as it is an "off licence" application. However in many hospitals in the UK it will be used, but this should only be after all licensed or conventional treatments have been tried and as either part of an audited series or in a trial setting.

Currently results are awaited from the largest randomised trial (RCT) comparing Botulinum toxin to "placebo" (or dummy medication). Botox itself is also currently undergoing another RCT for regulatory purposes. It is expected that Botox will be licensed within probably 2-3 years. One of the challenges is to identify the correct dosing to maximise symptom relief but reduce the risk of problems emptying the bladder or recurrent infections. Despite not having a licence yet it is acknowledged as a possible treatment option by NICE

There is a growing body of research evidence supporting the use of Botulinum toxin in treating nonneurogenic detrusor overactivity (overactive bladder). It is not a treatment for stress incontinence (leaking with coughing/sneezing/exertion). Botulinum toxin has also been used to treat bladder pain .

Consultants are at liberty to use Botulinum toxin "off licence" and pragmatically it is reasonably widely used in secondary care. However with funding constraints it may well not be funded routinely and case selection will lead to rationing. As indicated above the licensed treatments should be tried first including PTNS, a type of electrical therapy which has just received NICE approval in October. In terms of private practice this may be available but again funding may be an issue with patients needing to pay themselves rather than the insurance companies. Some insurers will fund initial treatment but not longer term.

The Botulinum toxin injection is given directly into the bladder muscle (detrusor). A telescope is passed through the urethra into the bladder and a fine needle is used to inject the muscle under direct vision. Usually 20 small injections are given scattered over the bladder wall. This procedure can be done under either general or local anaesthetic in a daycase setting or in a clinic under local anaesthetic. It does not require overnight admission to hospital as a rule. When the effects of the Botulinum toxin wear off, the injection can be repeated. This may be after 9-12 months.

When the procedure is performed under a local anaesthetic recovery is immediate. After a general anaesthetic, you should be fit to go home after 2-3 hours. The effect of the drug should be noticeable within 3-4 days.

The side effects of the procedure include passing blood in the urine and urinary tract infection. The side effects of the Botulinum toxin include voiding difficulty in 10-20% and more rarely a reaction to Botulinum toxin (flu like symptoms, generalised muscle weakness). If you develop voiding difficulty you will need to learn intermittent self catheterisation and may need to perform this several times a day for the first few weeks until the detrusor muscle starts to work more effectively again.

Success can be measured in different ways and to some extent depends on the expectations of the patient and clinician. 70-80% of patients will find the injection beneficial

You need to have had detrusor overactivity diagnosed on urodynamic testing and should have tried conventional treatments such as bladder retraining and anticholinergic medication (eg oxybutynin, solifenacin, fesoteradine or trospium). You need to be prepared to learn to self catheterise in case you develop problems emptying your bladder. This would not be a permanent problem. There are a few medications that interact with Botulinum toxin - including nifedipine, diltiazem, verapamil and amlodipine. It is not safe to have Botulinum toxin therapy if you are pregnant, if you are allergic to egg albumin or if you suffer from any of the following conditions: Myasthenia gravis, Eaton-Lambert Syndrome or amyotrophic lateral sclerosis.

Your general practictioner will need to refer you to a urologist or urogynaecologist for consideration of the treatment.

Your local urology or urogynaecology clinic can give you more information if they offer the procedure.

This information has been provided by:

Philip Toozs-Hobson, Clinical Director, Gynaecology Consultant, Urogynaecologist
Birmingham Women's Hospital

Claire Burton, Subspeciality Trainee Urogynaecology, Department of Pelvic Floor Medicine, Birmingham Women's Hospital