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.

A Soft Hand Exoskeleton With a Novel Tendon Layout to Improve Stable Wearing in Grasping Assistance.

We present a novel soft exoskeleton providing active support for hand closing and opening. The main novelty is a different tendon routing, folded laterally on both sides of the hand, and adding clenching forces when the exoskeleton is activated. It improves the stability of the glove, diminishing slippage and detachment of tendons from the hand palm toward the grasping workspace. The clenching effect is released when the hand is relaxed, thus enhancing the user's comfort. The alternative routing allowed embedding a single actuator on the hand dorsum, resulting more compact with no remote cable transmission. Enhanced adaptation to the hand is introduced by the modular design of the soft polymer open rings. FEM simulations were performed to understand the interaction between soft modules and fingers. Different experiments assessed the desired effect of the proposed routing in terms of stability and deformation of the glove, evaluated the inter-finger compliance for non-cylindrical grasping, and characterized the output grasping force. Experiments with subjects explored the grasping performance of the soft exoskeleton with different hand sizes. A preliminary evaluation with Spinal Cord Injury patients was useful to highlight the strengths and limitations of the device when applied to the target scenario.

International spinal cord injury male sexual function and female sexual and reproductive function basic data sets-version 2.0.

STUDY DESIGN: Data set review and modification. OBJECTIVE: To describe modifications in the International Spinal Cord Injury (SCI) Male Sexual Function Basic Data Set Version 2.0 and the International SCI Female Sexual and Reproductive Function Basic Data Set Version 2.0. SETTING: International expert work group using on line communication. METHODS: An international team of experts was compiled to review and revise the International SCI Male Sexual Function and Female Sexual and Reproductive Function Basic Data Sets Version 1.0. The group adapted Version 1.0 based upon review of published research, suggestions from concerned individuals and on line work group consensus. The revised data sets were then posted on the International Spinal Cord Society (ISCoS) and American Spinal Injury Association (ASIA) websites for 2 months for review. Subsequently, the data sets were approved by the ISCoS Scientific and Executive Committees and ASIA board of directors. RESULTS: The data sets were modified to a self-report format. They were reviewed for appropriateness for the pediatric age group and adapted to include a new variable to address the issue of sexual orientation. A clarification of the difference between the data sets and the autonomic standards was also developed. CONCLUSION: Sexuality is a continuously evolving topic. Modifications were needed to address this topic in a comprehensive fashion. It is recommended that Version 2.0 of these data sets are used for ongoing documentation of sexual status in the medical record and for documentation of sexual concerns during on-going research.