Sacral neuromodulation and Botulinum toxin A for refractory idiopathic overactive bladder: a cost-utility analysis in the perspective of Italian Healthcare System.

OBJECTIVES: To assess the relative cost-effectiveness of two therapeutic strategies: one starting with sacral neuromodulation (SNM) versus one starting with Botulinum toxin A (BTX-A) for the management of refractory incontinent idiopathic overactive bladder (OAB) patients, from the perspective of the Italian National Health Service (INHS). METHODS: Direct medical costs (2011) and benefits (quality-adjusted life years-QALYs) were assessed over a ten-year time frame adapting to the Italian practice a published Markov model. Clinical inputs were based on the published literature and on the expert opinion. Resource consumption rates were provided by clinical experts; unit costs were collected from a single hospital accounting and from standard tariff lists and public prices. Interventional procedures and management of adverse events were costed through a micro-costing approach. The primary outcome was incremental costs per QALYs gained (i.e. differential costs divided by differential benefits). Deterministic (DSA) and probabilistic (PSA) sensitivity analyses were conducted to assess the robustness of the model. RESULTS: Starting with SNM appears to be cost effective (i.e. under 40.000/QALY) from year three (21,259/QALY) onwards and becomes dominant (i.e. more effective and less costly) at year ten: cumulative costs were 32,975 for early SNM and 33,309 for early BTX-A, while cumulative QALYs were 7.52 and 6.93, respectively. At year ten, DSA suggests the results robustness and 99.8 % of the PSA iterations fell within the cost-effectiveness threshold. CONCLUSIONS: A therapeutic strategy starting with SNM may be considered cost effective in the midterm and cost saving in the long-term treatment of idiopathic OAB from the INHS perspective.

Treating erectile dysfunction and central neurological diseases with oral phosphodiesterase type 5 inhibitors. Review of the literature.

INTRODUCTION: Erectile dysfunction (ED) is reported in a high percentage of patients with central neurological disorders (CND). AIM: An up-to-date review on oral phosphodiesterase 5 inhibitors (PDE5): sildenafil, tadalafil, and vardenafil for individuals with CND and ED. MAIN OUTCOME MEASURES: Various questionnaires on ED, such as the International Index of Erectile Function composed of 15 questions. METHODS: Internationally published clinical studies evaluating the efficacy and safety of PDE5 on subjects with CND and ED were selected. RESULTS: Overall, 28 articles on PDE5 used to treat patients with CND and ED were included. With each of the three PDE5 compared to placebo or erectile baseline, literature reported significant statistical improvement (P < 0.01; P < 0.05) only in patients with spinal cord injury (SCI). PDE5 efficacy was documented for SCI patients up to 10 years. The most frequent predicable factor for PDE5 success was the presence of upper motoneuron lesion. Each of the three clinical sildenafil studies documented statistically significant improvement on erectile function in Parkinson's patients (P < 0.01; P < 0.05). Two studies reported discordant results about sildenafil's effectiveness on multiple sclerosis (MS) patients; one on tadalafil showed significant statistical efficacy on erection versus baseline (P < 0.01; P < 0.05). The only spina bifida article determined that sildenafil remarkably improved erectile function. Overall, drawbacks were mostly slight-moderate, except in subjects with multiple system atrophy where sildenafil caused severe hypotension. CONCLUSIONS: PDE5 represent first line ED therapy only for SCI patients, though treatment results through meta-analysis were not possible. Encouraging results are reported for Parkinson's and MS patients. PDE5 use for other CND patients is limited for various reasons, such as ED and concomitant libido impairment caused by depression and/or sexual endocrinology dysfunctions, and because PDE5 may cause a worsening of neurological illness. Medical centers staffed by health professionals able to counsel patients on the possible use of PDE5 are needed.

[Standard pharmacological treatment and new therapies for overactive bladder]. / Terapia farmacologica standard e nuove terapie per la vescica iperattiva.

The prevalence of overactive bladder (OAB) in adult males varies from 10.2% to 17.4%, and in females from 7.7 to 31.3. 16.5% of the adult population presents symptoms consistent with OAB; of these, 37.2% are actually affected. The OAB has a significant effect on the quality of life. Initial treatment includes behavioral therapy, physiotherapy and antimuscarinic drugs. In patients where behavioral modifications fail, treatment is associated with antimuscarinics. The antimuscarinic agents used to treat OAB showed some efficacy, but adverse events too, such as dry mouth, constipation, headache and blurred vision. In selected cases unresponsive to antimuscarinic therapy, it is possible to use second-line treatments represented by sacral neuromodulation and botulinum toxin type A both for idiopathic detrusor overactivity, where it is still an experimental treatment, and for neurogenic cases with 2011 FDA approval. Surgical options represent the last choice for selected cases.