Aim:To perform an early cost-effectiveness analysis of in vitro expanded myoblasts (IVM) and minced myofibers versus midurethral slings (MUS) for surgical treatment of female stress urinary incontinence. Methods: Cost-effectiveness and sensitivity analyses were performed using a decision tree comprising previously published data and expert opinions. Results & conclusion: In the base case scenario, MUS was the cost-effective strategy with a negative incremental cost-effectiveness ratio compared with IVM and a positive incremental cost-effectiveness ratio compared with minced myofibers. However, the sensitivity analysis indicates that IVM may become an alternative providing greater effect at a higher cost. With the possibility of becoming more effective, IVM treatment would be advantageous over MUS given its reduced invasiveness and lower risks of complications. Urinary incontinence (UI) is a common medical condition that has a negative impact on the quality of life of individuals of all ages, racial and ethnic groups. The prevalence of UI is about two-to-four-times higher in women than in men, ranging from 11 to 57% [1]. The most common subtype is stress urinary incontinence (SUI), affecting roughly 50% of any women with UI [2]. SUI describes a condition where there is an involuntary leak of urine when intra-abdominal pressure rises, for example, when coughing, sneezing, laughing or during other physical activity. SUI has not only a severe impact on quality of life but it also places a substantial economic burden on the healthcare system and society [3][4][5]. In the USA, for example, it has been estimated that in 1998, the average direct medical cost of SUI amounted US$5642 per patient, while the indirect workplace expenses were US$4208 [3]. Evidence suggests that these costs have experienced an age-related increase over the last years [5].The clinical management of SUI is complex and may involve conservative treatments, such as pelvic floor muscle training and pharmacotherapy, as well as surgical procedures. Currently, the gold standard for surgical management of SUI in women is the midurethral sling (MUS), which displays a cure rate of 80-95% [6][7][8]. While MUS has a high success rate, 5-20% of the patients will have persisting incontinence thus needing to undergo sling removal and subsequent treatment [9]. The postoperative complications reach as high as 7.2% for erosion and the risk of getting a perioperative urinary tract infection is 17.2% [10]. As an alternative to MUS implantation, with the goal of targeting the underlying etiology rather than relieving the symptoms, cell-based therapies (CBTs) have recently emerged [11]. Among the different modalities of CBT, intraurethral injection of autologous skeletal myoblasts appears as one of the most promising regenerative therapies for SUI [12]. While various large-scale clinical trials are still ongoing, results from the initial clinical studies have shown that these approaches appear to be safe and moderately effective. Remarkably, a recent study has shown ...