OBJECTIVES: To estimate the costs and outcomes associated with the treatment of NASHA/Dx (Solesta®) for fecal incontinence (FI) compared with sacral nerve stimulation (InterStim®) and anal sphincteroplasty. METHODS: A five-year Markov model was developed to analyze the cost-utility associated with: 1) NASHA/Dx; 2) sacral nerve stimulation (SNS); and 3) anal sphincteroplasty (AS) after failure of conservative therapy.  Costs and outcomes were based on the published literature and other public sources.  Costs and QALYs were discounted at a rate of 3% annually.  Probability sensitivity analyses were used to estimate the robustness of the base case and scenarios.  The probability and utility variables were modeled as beta-distributions; costs were modeled as lognormal distributions.  One-way sensitivity analyses were used to evaluate the impact of variations related to key cost variables.  A willingness-to-pay (WTP) analysis was conducted for a threshold of twice the US GDP per capita; cost-effectiveness acceptability curves were constructed.  ICERs less than the specified threshold are considered cost-effective. RESULTS: The base case Markov model yielded an incremental cost-effectiveness ratio (ICER) for NASHA/Dx vs. conservative therapy (CT) of $30,123 / QALY (Quality Adjusted Life Year). The ICER for SNS vs. CT was $51,187 / QALY; the ICER for AS vs. CT was $56,564 / QALY.  A sensitivity analysis for the long-term effectiveness of NASHA/Dx resulted in an ICER of $40,327 for NASHA/Dx vs. CT.  Probabilistic sensitivity analysis demonstrated that NASHA/Dx was cost-effective for 78% of the simulations at a threshold of $70,654 / QALY gained. CONCLUSIONS: For FI patients, NASHA/Dx has demonstrated cost-effectiveness.  Due to higher acquisition costs, SNS and anal sphincteroplasty were associated with larger ICERs.  Sensitivity analyses indicated NASHA/Dx was cost-effective under all scenarios modeled.  WTP analyses demonstrated that NASHA/Dx was highly probable to be cost-effective in the US context.