Cost of Sacral Neuromodulation

General Issues in Urge Incontinence Costs

Urinary incontinence and urinary retention are a costly illness that affect personal resources, medical treatment and quality of life. The overall prevalence of overactive bladder is similar between men (16.0%) and women (16.9%), but sex specific prevalence differed substantially by severity of symptomes [150]. Anatomic differences increase the frequency of urge incontinence linked to bladder overactivity among women compared with men. In women, prevalence of urge incontinence increase with age from 2.0% to 8.9%, and in men from 0.3% to 19%. Moreover, symptome occurrence is later in age in men. United States most recent estimates of the annual direct costs of incontinence in all ages are approximately $16 billion:$11 billion in community and $5 billion in nursing home (1994 dollars) [59]. These costs estimate increased by 250% over 10 years [86], greater than can be accounted by medical inflation. Data from the National Overactive Bladder Evaluation (NOBLE) survey in the United States had shown that the estimated total economic cost of overactive bladder was $12.02 billion in 2000, with $9.17 and $2.85 billion incurred in the community and institutions, respectively. NOBLE program in the US surveyed approximately 5,000 adults. The average cost per community-dwelling person with overactive bladder was $267 per year [87]. A prospective population study in US suggested that total urinary incontinence expense is as high as $16.3 billion, with 78% of cost issued from women and 22% from men. Overall surgical cost of incontinence (all techniques) represent 4 years of pads and care. Similar findings were shown in several non USA studies issued from European and Autralian studies [86]. Apart from the cost to the health system there is also the burden to the patient and his/her family [76]. Urinary incontinence may also affect individual's lost work time or interfere with job performance and productivity. Embarrassment, shame, need to change clothing altered social interactions, loss of self esteem, depression are frequent. Given the large number of patients (mainly younger women) and the relatively high prevalence of incontinence, future efforts to objectively quantify such impact is needed.

Expected Cost per Patient of Sacral Nerve Stimulator Implant Treatment

The initial expense of the therapy, especially measured over the 7-10 year life of any neurostimulator should be considered in relation to the potential savings to the healthcare system and to the effect on the patient's quality of life. Abrams et al. [3] examine the benefit-risk profile of neuromodulation in treating refractory urge incontinence and other voiding disorders. They feel that both efficacy and safety have improved beyond the earlier studies as the development of new percutaneous technology and the minimally invasive placement of leads have improved the technique.

No studies of the cost-effectiveness of sacral nerve stimulator implant treatment were found in the literature, but some economic data looking at direct costs up to 12th month post implantation are available. Cost of equipment (percutaneous nerve evaluation and sacral nerve stimulator) is approximately of 9000 € per patient. It may be higher if bilateral stimulation is chosen. Surgery and re-surgery costs have been evaluated nearly to 8000€ in Australian review [117]. Oral anticholinergic treatment cost is much lower (200€ per year) but neuromodulation is usually used in refractory cases to these therapies. Reduction of pads and laundry for urge incontinence and catheterization for urinary retention is the main factor of cost reduction [131]. Unfortunately, studies have showed significant consummation variability of these equipments and some may have overestimated this data [86]. Over six months, sacral nerve stimulator implant treatment has an estimated cost per patient initiated to treatment with percutaneous sacral nerve evaluation of approximately 18 700€. These costs include medical treatment and re-operations arising from complications, for both indications (incontinence, urinary retention) [117].

Capellano et al. [37] reported economical and social impact of sacral nerve modulation therapy in 62 patients with lower urinary tract dysfunction. These patients were enrolled in the economic session of the Italian Sacral Nerve Modulation Registry from February 2000 to September 2002. 41 were incontinent patients (61% female) and 21 were affected by chronic urinary retention (71% female). A quarterly based analysis comparing the baseline data to the last follow-up (12th month) was performed. Visits to the general practitioner decreased from 1.1 to 0.05 (p < 0.01), visits to the urologist did not change significantly from baseline (1.5 to 1.2). Diagnostic tests decreased from 2 to 0.8 (p < 0.01). In the use of pads a major change was observed from a daily use of 2.1 (three months expenses per patient of €120.96) to 0.5 (three months expenses per patient of €28.8) (p = 0.08); and for urinary retention the use of catheters decreased from 1.1 baseline (three months expenses per patient of €178.2) to 0.1 at 12 months (three months expenses per patient of €16.2) (p = 0.09). Costs of drug consumption decreased significantly (p < 0.05) from €47.24 to €10.53. This study suggests that sacral nerve modulation therapy is efficient to improve the economic management of patients with lower urinary tract dysfunction. Furthermore, the reduction in the use of pads and catheters has also a positive effect on quality of life and patients' social interaction [36].

It has been suggested that the implant may last for up to five years. Over the long term the total cost saving in incontinence products is likely to increase if the device continues to be effective, but further revision sur-

gery may also be required. Optimal treatment can be define at the end of a fine tuning process which could take several months, during which specialist visits decrease progressively, allowing some cost reduction. A longer follow-up is therefore requested in order to evaluate long term costs after implant therapy is stabilized.

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