Mariotti Gianna, Salciccia Stefano, Viscuso Pietro, Bevilacqua Giulio, Casale Paolo, Frisenda Marco, Di Pierro Giovanni Battista, Cattarino Susanna, Gentilucci Alessandro, Rosati Davide, Sciarra Beatrice, Sciarra Alessandro
Department of Maternal-Infant and Urologic Sciences, 'Sapienza' University of Rome, Policlinico Umberto I Hospital, Rome, Italy.
Department of Urology, Humanitas Clinical and Research Center IRCCS, Humanitas, Milan, Italy.
Curr Stem Cell Res Ther. 2023;18(3):429-437. doi: 10.2174/1574888X17666220616100621.
The aim of this systematic review and meta-analysis is to analyze clinical trials on the use of autologous stem cell [SC] injection for the treatment of stress urinary incontinence [SUI] in humans.
We analyzed the effect in terms of UI improvement and continence recovery after treatment. A literature search was performed following the PRISMA guidelines. Entry into the analysis was restricted to data collected from clinical prospective trials on humans, including female and male patients with SUI. We performed a cumulative meta-analysis to explore the trend in the effect size across different groups at follow-up. Available data were compared in terms of Event Rate [ER] for the percentage of pad-free patients.
12 trials were enclosed in the analysis. The sample size of patients with SUI ranged from 5 to 123 cases, mainly female cases. Autologous muscle-derived stem cells [MDSCs] were used in 9 and adipocyte- derived SCs [ADSC] in 3 trials. Considering a random effect model, ER of continence recovery was 0.41 [95%CI 0.29 - 0.54], with similar results between the ADSC [ER, 0.40;95%CI 0.12 - 0.69] and the MDSC group [ER 0.41; 95%CI 0.27-0.55] [I2 84.69%; Q 104.69 - p<0.01] [Test of group differences p=0.96].
Autologous MDSC or ADSC injection to treat SUI is demonstrated to be a safe procedure and a 41% mean rate of continence recovery is described. A higher effort should be produced to design better clinical trials, objectively evaluating either modifications inside the urethral sphincter or long-term functional results in terms of pad test and UI questionnaires.
本系统评价和荟萃分析旨在分析自体干细胞注射治疗人类压力性尿失禁(SUI)的临床试验。
我们从治疗后尿失禁改善和控尿恢复方面分析效果。按照PRISMA指南进行文献检索。纳入分析的数据仅限于从人类临床前瞻性试验收集的数据,包括患有SUI的女性和男性患者。我们进行累积荟萃分析以探索随访时不同组效应大小的趋势。根据无尿垫患者百分比的事件发生率(ER)比较可用数据。
12项试验纳入分析。SUI患者样本量为5至123例,主要为女性病例。9项试验使用自体肌肉来源干细胞(MDSCs),3项试验使用脂肪来源干细胞(ADSCs)。考虑随机效应模型,控尿恢复的ER为0.41(95%CI 0.29 - 0.54),ADSC组(ER,0.40;95%CI 0.12 - 0.69)和MDSC组(ER 0.41;95%CI 0.27 - 0.55)结果相似(I² 84.69%;Q 104.69 - p<0.01)(组间差异检验p = 0.96)。
自体MDSC或ADSC注射治疗SUI被证明是一种安全的方法,控尿恢复平均率为41%。应做出更大努力设计更好的临床试验,客观评估尿道括约肌内部的改变或尿垫试验和尿失禁问卷方面的长期功能结果。