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Assessment of the effects of autologous muscle-derived cell injections on urethral sphincter morphometry using 3D/4D ultrasound.
World Journal of Urology ( IF 3.4 ) Pub Date : 2020-01-14 , DOI: 10.1007/s00345-020-03076-4
Salima Ismail 1 , Mélanie Morin 2 , Le Mai Tu 1
Affiliation  

PURPOSE The primary objective was to evaluate the effect of autologous muscle-derived cell (AMDC) injections on the urethral sphincter morphometry compared to placebo injections. Secondary aims were to explore the reduction of stress incontinence episode frequency (IEF) and factors associated with the efficacy of AMDC. METHODS This prospective randomized-controlled study compared the urethral sphincter volumes of participants who had received either an intra-sphincteric injection of 4 cc AMDC in injection media or 4 cc placebo solution, using a transperineal 3D/4D ultrasound at baseline and at 12 months. The reduction of stress IEF on 3-day bladder diary and potential predictors at baseline for response to AMDC were assessed. RESULTS Fifty-eight participants were included in the study. Compared to baseline, the mean total and external sphincter volumes increased significantly in both groups (respectively, p = 0.001 and p < 0.001 in the AMDC group, p < 0.001 and p = 0.005 in the placebo group) at 12 months. Both groups showed a significant reduction of stress IEF compared to baseline (p = 0.03 and p ≤ 0.001 for AMDC and placebo groups, respectively). There were no between-group differences regarding total and external sphincter volumes and reduction of stress IEF. A longer urethral length (p ≤ 0.001) and a larger external sphincter volume (p ≤ 0.05) were significantly associated with lower stress IEF. CONCLUSION Significant increases of sphincter volumes as well as reduction of stress IEF occurred among the AMDC and placebo injection groups with no between-group differences at 12 months. A longer urethral length and a larger external sphincter volume at baseline were identified as potential predictors of AMDC injection response.

中文翻译:

使用3D / 4D超声评估自体肌肉来源的细胞注射对尿道括约肌形态测量的影响。

目的主要目的是评估自体肌肉衍生细胞(AMDC)注射液与安慰剂注射液相比对尿道括约肌形态的影响。次要目的是探索减少压力性尿失禁发作频率(IEF)和与AMDC疗效相关的因素。方法这项前瞻性随机对照研究比较了基线和第12个月使用会阴3D / 4D超声在注射介质中或在4cc安慰剂溶液中接受括约肌内注射4 cc AMDC或4 cc安慰剂的参与者的尿道括约肌容量。评估了3天膀胱日记中的应激IEF的降低以及基线对AMDC的潜在预测因素。结果本研究纳入了58名参与者。与基线相比,两组在12个月时的平均总括约肌和外部括约肌体积均显着增加(AMDC组分别为p = 0.001和p <0.001,安慰剂组为p <0.001和p = 0.005)。与基线相比,两组均显示压力IEF显着降低(AMDC组和安慰剂组分别为p = 0.03和p≤0.001)。关于总括约肌和外部括约肌的体积以及压力IEF的降低,组间没有差异。较长的尿道长度(p≤0.001)和较大的外部括约肌体积(p≤0.05)与较低的应力IEF显着相关。结论在AMDC和安慰剂注射组之间,括约肌容量显着增加,而IEF降低,在12个月时组间无差异。
更新日期:2020-01-14
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