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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 ...
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 ...
Urinary incontinence symptoms are highly prevalent among women, have a substantial effect on health-related quality of life and are associated with considerable personal and societal expenditure. Two main types are described: stress urinary incontinence, in which urine leaks in association with physical exertion, and urgency urinary incontinence, in which urine leaks in association with a sudden compelling desire to void. Women who experience both symptoms are considered as having mixed urinary incontinence. Research has revealed overlapping potential causes of incontinence, including dysfunction of the detrusor muscle or muscles of the pelvic floor, dysfunction of the neural controls of storage and voiding, and perturbation of the local environment within the bladder. A full diagnostic evaluation of urinary incontinence requires a medical history, physical examination, urinalysis, assessment of quality of life and, when initial treatments fail, invasive urodynamics. Interventions can include non-surgical options (such as lifestyle modifications, pelvic floor muscle training and drugs) and surgical options to support the urethra or increase bladder capacity. Future directions in research may increasingly target primary prevention through understanding of environmental and genetic risks for incontinence.
ObjectiveThe objective of this study is to describe a standardised technique of full TOT removal with groin dissection and to report clinical improvement, satisfaction, safety and long‐term functional, quality of life (QoL) and sexual QoL outcomes.Materials and methodsA retrospective review enrolling all women who had full TOT removal, in a tertiary referral centre from May 2017 to November 2020. Functional outcomes, satisfaction and QoL were assessed using a bespoke composite questionnaire (UDI‐6, EQ‐5D‐5L and ICIQ‐S) with additional questions on sexual QoL. Secondary outcomes were post‐operative recurrent stress urinary incontinence (SUI) and complication rate according to the Clavien‐Dindo classification.ResultsFull TOT removal using a vaginal approach and bilateral groin/para‐labial incisions was performed in 67 patients. Chronic pelvic pain was the main indication for mesh removal (51% of cases, n = 34). QoL questionnaires were answered by 43 patients. The satisfaction rate was high 86% (n = 37), and 81% (n = 35) of the patients considered the surgery successful. Seventy per cent (n = 30) of patients returned to having a sexual life after surgery. Recurrent SUI was reported in 32% (n = 14) of cases. The complication rate was 10% (7/67), all of them Clavien–Dindo ≤2.ConclusionDespite a high rate of postoperative bothersome SUI, full TOT removal with bilateral groin dissection improves pain and QoL. It is associated with a high overall satisfaction rate and an acceptable rate of complications.
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