Autologous Muscle Derived Cells for Treatment of Stress Urinary Incontinence in Women

Peters, Kenneth M.; Dmochowski, Roger R.; Carr, Lesley K.; Robert, Magali; Kaufman, Melissa R.; Sirls, Larry; Herschorn, Sender; Birch, Colin; Kultgen, Patricia L.; Chancellor, Michael B.

doi:10.1016/j.juro.2014.02.047

Cited by 112 publications

(90 citation statements)

References 11 publications

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“…They found that higher-dose groups (100 × 10 6 and 200 × 10 6 MDCs) were associated with greater response in terms of reduction in SUI frequency and pad weight. 26 Similarly, other clinical trials using myoblasts or MDSCs in treatment of female SUI were published by Blaganje et al, 27 Carr et al, 28 and Stangel-Wojcikiewicz. 29 All of them confirmed a high safety profile and encouraging short-term success rates in stem-cell-based therapy for SUI treatment.…”

Section: Future Sui Treatmentsmentioning

confidence: 89%

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Stress urinary incontinence in women: Current and emerging therapeutic options

Shamout

Campeau

2017

CUAJ

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Surgical management of stress urinary incontinence (SUI) is most commonly achieved by midurethral synthetic sling (MUS) insertion as a first-line surgical option. A great deal of research continues to evolve new management strategies to reach an optimal balance of high efficacy and minimal adverse events. This expert opinion review provides a brief and comprehensive discussion of recent advances and ongoing research in the management of SUI, with an emphasis on single-incision mini-slings, vaginal laser treatment, and cell-based therapy. It is based on data obtained from numerous published meta-analyses and original studies identified through literature search. Single-incision mini-slings appear equally effective initially compared with standard MUS (retropubic or transobturator) for the treatment of female SUI; however, this efficacy lacks durability evidence beyond one-year followup. There is a lack of sufficient clinical evidence to currently confirm long-term safety and effectiveness of cell-therapy and non-ablative vaginal laser therapy, besides suggestion of apparent initial safety. There are still significant challenges to overcome before widespread clinical practice of the latter two modalities. Future research should be aimed at identifying groups of patients who might benefit from these minimally invasive therapeutic options.

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Section: Future Sui Treatmentsmentioning

confidence: 89%

“…The data showed that injection of autologous muscle-derived cells did not lead to any adverse outcomes after 12 months of followup. 26 In the near future, tissue engineering strategies may increasingly be applied, as various bioengineered degradable scaffolds have been proposed and studied in animal models.…”

Section: Future Sui Treatmentsmentioning

confidence: 99%

Stress urinary incontinence in women: Current and emerging therapeutic options

Shamout

Campeau

2017

CUAJ

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“…A pooled mean was calculated from all three resulting in an estimated base case cure rate of 68%. Although there are other studies in the literature showing similar efficiency for IVM, they were not included here due to lack of definition the 'cured' patient population [34,35]. All patients not included in the group of 'cured' were added to the group 'not cured', despite having shown improvements.…”

Section: Probabilitiesmentioning

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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“…22 Trials have shown positive effects without serious adverse effects. In those studies, however, cells are administered a long time after the causal injury, in symptomatic patients.…”

Section: Clinical Scenario and Identification Of Potential Beneficiariesmentioning

confidence: 99%

The impact of vaginal delivery on pelvic floor function – delivery as a time point for secondary prevention

Callewaert

Albersen

Janssen

et al. 2015

BJOG

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Please cite this paper as: Callewaert G, Albersen M, Janssen K, Damaser MS, Van Mieghem T, van der Vaart CH, Deprest J. The impact of vaginal delivery on pelvic floor function -delivery as a time point for secondary prevention: a commentary. BJOG 2016;123:678-681. Pelvic floor disorders (PFD) cover a spectrum of conditions, including pelvic organ prolapse (POP), urinary (UI) and fecal incontinence (FI). Vaginal birth is considered the leading risk factor. Passage of the fetal head is associated with exceptional forces on and stretching of the pelvic floor. Since vaginal delivery occurs under medical supervision, it is the ideal moment for preventive action.1 Measures could be initiated promptly, restoring the damage caused by vaginal delivery to prevent PFD from developing. One of the experimental strategies currently being explored is the use of stem cells to boost the innate healing response. Though apparently futuristic, the experimental evidence of its efficacy is accumulating. The deleterious effects of childbirth on the pelvic floorAlthough PFD is a multifactorial disease there is ample evidence that vaginal delivery (VD) causes pelvic floor trauma. These mechanisms are believed to be essentially mechanical and ischaemic in nature. The impact of VD on the anal sphincter has been long recognised. The prevalence of anal sphincter injury following VD as visible on ultrasound is as high as 24.5% in prospective studies.2 VD makes the pubococcygeal muscles stretch to at least twice their initial length.3 In experimental conditions in non-pregnant rabbits, stretching a skeletal muscle by half its length is already sufficient to cause function loss. 4 Whether this threshold also applies to the levator and the peripartum is uncertain, but it should be no surprise that there is clinically demonstrable levator trauma following VD in one out of three women. 5VD also damages the innervation of the pelvic floor. The anal sphincter as well as the levator plate innervation may be injured by stretch, although for levator injury, compression and ischaemia may also contribute. 6 As a consequence, 40% of women display increased pudendal nerve terminal motor latency, although this recovers in two-thirds of women.7 Electromyography of the levator ani muscle has shown neuropathic injury in one quarter of women after a single VD, though that study did not correlate the observed changes to pelvic floor function. 8The urethral rhabdomyosphincter is too small for reliable electromyography; nonetheless, a reduction in urethral closure pressure after vaginal delivery has been shown, though not confirmed by other studies. 9There should be no doubt that VD leads to immediate measurable damage, but only in a minority of the cases does this lead to immediate loss of function or symptoms. Over time, however, up to half of women who delivered vaginally display PFD, as recently documented in several large studies. By a unique combination correlating obstetrical factors concerning first delivery and long-term anatomical and functional outc...

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Autologous Muscle Derived Cells for Treatment of Stress Urinary Incontinence in Women

Abstract: Autologous muscle derived cells for urinary sphincter repair at doses of 10, 50, 100 and 200×10(6) cells appears safe. Efficacy data suggest a potential dose response with a greater percentage of patients responsive to higher doses.

Cited by 112 publications

References 11 publications

Stress urinary incontinence in women: Current and emerging therapeutic options

Stress urinary incontinence in women: Current and emerging therapeutic options

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

The impact of vaginal delivery on pelvic floor function – delivery as a time point for secondary prevention

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