CONSENSUS STATEMENT FOR THE TREATMENT OF OVERACTIVE BLADDER OUTSIDE THE OPERATING THEATRE USING BOTOX®
Overactive bladder (OAB) is a clinical condition comprising symptoms of urgency, frequency and nocturia, with or without, urge urinary incontinence. There are no current figures on the epidemiology of OAB in Australia but its prevalence has been reported as approximately 16% in some European and American cohorts [1,2]. OAB is recognised as a common disorder affecting quality of life (QOL) and there is also a significant economic cost involved. In Australia in 2010, the total financial cost of urinary incontinence (UI) (excluding burden of disease) was estimated to be nearly $43 billion .
Botulinium Toxin A, here on referred to as Botox®, (the proprietary Allergan product listed on the Pharmaceutical Benefits Schedule in Australia for use in urinary incontinence secondary to OAB and neurogenic detrusor overactivity) is well established in the treatment of OAB that is refractory to medical management with oral or topical agents. This is reflected with Botox® being recommended as a standard therapy in refractory OAB in Australian, UK, European and US guidelines (4).
The traditional procedural environment in Australia for the injection of Botox® has been the operating theatre. In the private sector this has been largely borne out of a traditional model of care centered around visiting urologists admitting patients to a private hospital to perform procedures. Small procedures, such as intravesical Botox® injections, are usually not performed in the rooms/outpatient environment as most consultant rooms in Australia have minimal equipment for performing minor procedures, particularly as there are no financial incentives to perform in rooms procedures given that there isn't any available funding from the private health insurance sector.
There are substantial compliance and equipment costs that are borne by the proceduralist if procedures are carried out in the private rooms environment. The business case for a procedural rooms model in the current environment of procedural remuneration structured around the Medical Benefits Schedule is weak. The cost of capital purchases, nursing support, cleaning and sterilizing, in addition to disposable items such as needles, local anaesthetic and cystoscopy sheaths, is considerable which makes cystoscopic injection of Botox® a challenge in the rooms. A facility fee for accredited practices would appear to be a worthwhile initiative if this is to develop.
The procedure for cystoscopic administration of Botox® lends itself to an outpatient or lower acuity model than the standard operating theatre. Owing to restricted access to theatre in the public sector, a model of local anaesthetic instillation for Botox® administration has been successful, and whilst the incentive for this in the public sector is strong, the same cannot be said for the private sector, where theatre availability is not limited and procedural remuneration is higher in a private hospital due to the ability to claim the procedural cost against the patient’s private health insurance.
The model of local anaesthetic procedural administration in an outpatient setting is practiced widely in North America and European centres, with many publications and guidelines confirming efficacy, successful patient outcomes and acceptance of this technique.
Cost sharing via a facility fee to practices would appear to increase the chances of the administration of Botox® and other types of minor procedures being viable in rooms. Large urology group practices also would appear to have a better chance of reaching a suitable financial arrangement, as the cost sharing of expensive equipment would obviously bring the set up costs down. This would have substantial benefits for patients in terms of cost, particularly those with large private insurance excesses, and there may also be incentive for uninsured patients to have an in rooms procedure with an out of pocket cost, especially as there is often a long wait for this relatively minor procedure in the public sector.
It should be noted that not all patients are suitable for treatment outside the operating theatre. It is important that a new funding model does not prevent or preclude in hospital treatment, as for some patients this is required.
Those patients that require sedative anaesthesia or greater peri-operative monitoring, need to still be able to access Botox® administration in a more traditional operating theatre environment. This is particularly an issue for spinal cord injured patients at risk of autonomic dysreflexia.
As professional organizations, USANZ and UGSA support the initiative of Allergan in working towards a proposal of a different model of funding to allow rooms based procedures to be performed in a more cost effective way. This would have substantial benefits for patients in terms of cost and patient satisfaction, and then additional flow on effects for the broader community in terms of reduced procedural costs and increased accessibility to treatment.
- Milsom I, Abrams P, Cardozo L, Roberts RG, Thuroff J, Wein AJ. How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int 2001; 87: 760–6
- Stewart WF, Van Rooyen JB, Cundiff GW et al. Prevalence and burden of overactive bladder in the United States. World J Urol 2003; 20: 327–36
- Deloitte Access Economics. The economic impact of incontinence in Australia. Continence Foundation of Australia. 2011. Available at: http://www.continence.org.au/data/files/Access_economics_report/dae_ incontinence_report__19_April_2011.pdf. Accessed March 2015
- Tse V, King J, Dowling C, English S, Gray K, Millard R, O'Connell H, Pillay S, Thavaseelan J.Conjoint Urological Society of Australia and New Zealand (USANZ) and Urogynaecological Society of Australasia (UGSA) Guidelines on the management of adult non-neurogenic overactive bladder. BJU Int. 2016 Jan;117(1):34-4