Intrasphincteric autologous myoblast injections with electrical stimulation for stress urinary incontinence

Blaganje, Mija; Lukanović, Adolf

doi:10.1016/j.ijgo.2011.11.029

Cited by 54 publications

(61 citation statements)

References 21 publications

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“…This rate represents the average costs of a defined group in the healthcare system, in this case covering 25 different operations. For the IVM procedure, the costs associated with the DRG rate PG06B may increase if cell injection is accompanied by complementary therapies, such as transvaginal electrical stimulation [17].…”

Section: Limitations Of the Present Studymentioning

confidence: 99%

Cell-based Therapy for the Treatment of Female Stress Urinary Incontinence: An Early Cost–Effectiveness Analysis

et al. 2018

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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 ...

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Section: Limitations Of the Present Studymentioning

confidence: 99%

Cell-based Therapy for the Treatment of Female Stress Urinary Incontinence: An Early Cost–Effectiveness Analysis

et al. 2018

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“…All studies excluded urge incontinence or abnormal detrusor activity except for the study by Lee [5], which included 9 patients with mixed UI. However, in SUI, some only required that the patient had stress urinary incontinence (regardless of severity) [2,5,7,8] whereas others include only patients with SUI due to inherent sphincter weakness or at least exclude patients with urethral hypermobility > 45⁰ [1,3,9,10]. Nonetheless, it appears that the purpose of stem cells is to regenerate damaged sphincters, rather than to provide urethral support; in fact, some studies exclude patients with prolapse [2,4,9].…”

Section: Inclusion Criteria Of Patients In Studies For the Treatment mentioning

confidence: 99%

“…However, in SUI, some only required that the patient had stress urinary incontinence (regardless of severity) [2,5,7,8] whereas others include only patients with SUI due to inherent sphincter weakness or at least exclude patients with urethral hypermobility > 45⁰ [1,3,9,10]. Nonetheless, it appears that the purpose of stem cells is to regenerate damaged sphincters, rather than to provide urethral support; in fact, some studies exclude patients with prolapse [2,4,9]. In most studies, this treatment was tested in patients who had experienced previous failure of conservative treatment, including electrical stimulation [2,5,[7][8][9].…”

Section: Inclusion Criteria Of Patients In Studies For the Treatment mentioning

confidence: 99%

“…Nonetheless, it appears that the purpose of stem cells is to regenerate damaged sphincters, rather than to provide urethral support; in fact, some studies exclude patients with prolapse [2,4,9]. In most studies, this treatment was tested in patients who had experienced previous failure of conservative treatment, including electrical stimulation [2,5,[7][8][9]. One study [3] began with rehabilitation treatment, then performed stem-cell injection, and later performed electrical stimulation for 4 weeks; according to the author this favored stem-cell integration and regeneration.…”

Section: Inclusion Criteria Of Patients In Studies For the Treatment mentioning

confidence: 99%

“…One study [3] began with rehabilitation treatment, then performed stem-cell injection, and later performed electrical stimulation for 4 weeks; according to the author this favored stem-cell integration and regeneration. This was also combined with electrical stimulation in the study by Blaganje [9]. Only 1 study [2] considered prior treatment with bulking agents to be an exclusion criterion.…”

Section: Inclusion Criteria Of Patients In Studies For the Treatment mentioning

confidence: 99%

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Current Controversies in Stem-Cell Treatment of Urinary Incontinence in Women

Ferrer¹,

Machado-Linde²,

Prieto-Sánchez³

et al. 2014

Int J Gynecol Clin Pract

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Background: Urinary incontinence (UI) is a major cause of morbidity in the world and is believed to affect up to 46% of the female population Our objective was to analyze the papers that describe stem-cell treatments for UI in women. Methods: We performed a systematic review of the literature from 1946 to date that reports on clinical trials that use stem cells to treat women with urinary incontinence. Results: Nine articles (7 observational and 2 randomized studies) met the inclusion criteria. No major adverse effects were observed in any of the studies. However, the efficacy results differ widely, as the methodology used for studies was very different, as described below. Conclusion: Stem-cell therapy is promising but still experimental, and further study is needed to identify certain factors. These facts include the ideal type of patient eligible for treatment (apparently those in whom intrinsic urethral dysfunction predominates), and to determine if treatment should be isolated or combined with other cells or procedures, which are the optimal doses and if it is a cost effective procedure.

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A systematic review of stem cell therapy treatment for women suffering from stress urinary incontinence

Klapper-Goldstein

Tamam

Sade

et al. 2021

Intl J Gynecology & Obste

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Background Stem cell therapy (SCT) is used for regeneration of injured tissues. This seems a novel promising strategy for restoring urethral sphincter function in patients with stress urinary incontinence (SUI). Objective To summarize the clinical trials available to date on SCT for treatment of SUI in women. Search strategy PubMed, Cochrane Library, Scopus and Embase. Selection criteria Prospective interventional case series, randomized prospective interventional study and prospective cohort study assessing women aged 18 years and over diagnosed with SUI and treated by SCT were included. The quality of studies was finally assessed using the JBI Critical Appraisal Checklists according to the PRISMA guidelines. Data collection and analysis Nineteen studies (n = 773 patients) were selected for final analysis. These were conducted worldwide between the years 2005 and 2016. Although different cell types were used, general processing steps were similar. The follow‐up period ranged between 6 weeks and 6 years and included common subjective and objective evaluation tools. Results Overall, the studies imply that SCT for treatment of SUI is a safe and effective treatment. Conclusion In our opinion, the initial results of SCT for the treatment of SUI seem promising. Standardization and validation of this treatment modality is required before it can be recommended for routine use.

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Intrasphincteric autologous myoblast injections with electrical stimulation for stress urinary incontinence

Abstract: Intrasphincteric autologous myoblast injections followed by ES is minimally invasive and feasible, and safely produced promising initial results. EU Clinical Trials EudraCT No. 2009-012389-30 ClinicalTrials.gov identifier: NCT01355133.

Cited by 54 publications

References 21 publications

Cell-based Therapy for the Treatment of Female Stress Urinary Incontinence: An Early Cost–Effectiveness Analysis

Cell-based Therapy for the Treatment of Female Stress Urinary Incontinence: An Early Cost–Effectiveness Analysis

Current Controversies in Stem-Cell Treatment of Urinary Incontinence in Women

A systematic review of stem cell therapy treatment for women suffering from stress urinary incontinence

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