Autologous myoblasts and fibroblasts versus collagen for treatment of stress urinary incontinence in women: a randomised controlled trial (Retracted Article. See vol 372, pg 789, 2008)
Autologous myoblasts and fibroblasts versus collagen for treatment of stress urinary incontinence in women: a randomised controlled trial (Retracted Article. See vol 372, pg 789, 2008)
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DOI：
10.1016/s0140-6736(07)61014-9
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发表时间：
2007-06-30
期刊：
影响因子：
168.9
通讯作者：
Bartsch, Georg
中科院分区：
文献类型：
--
作者：
Strasser, Hannes;Marksteiner, Rainer;Bartsch, Georg
背景：临床前研究表明，经尿路注射自体成肌细胞可以促进横纹括约肌的再生，成纤维细胞可以帮助重建尿路粘膜下层。我们的目的是比较超声引导下自体细胞注射和内窥镜下胶原注射治疗压力性尿失禁的有效性和耐受性。其中42名妇女被随机分配接受经尿路超声引导下的自体成肌细胞和成纤维细胞注射，21名接受常规内窥镜下的胶原蛋白注射。第一个主要结果是基于24小时排尿日记、24小时尿垫试验和患者问卷的大小便失禁评分(范围0-6)。其他主要的结果指标是横纹括约肌的收缩能力以及尿路和横纹括约肌的厚度。分析采用意向治疗。这项试验在Control-Trials.com上注册，编号CCTNAPN-16630。在12个月的随访中发现，42名注射自体细胞的女性中有38名完全可控，相比之下，接受常规胶原蛋白治疗的21名患者中有2名完全可控。中位尿失禁评分从基线的6.0(IQR6.0~6.0，其中6代表完全性尿失禁)降至0(0~0)，而接受胶原蛋白(P<；0.0001)治疗的患者为6.0(3.5~6.0)。超声测量显示横纹括约肌的平均厚度从基线的2.13 mm(SD0.39)增加到3.38 mm(0.26)和2.32 mm(0.44)(P<；0.0001)。横纹括约肌的收缩能力从基线的0.58 mm(SD0.32)增加到1.56 mm(0.28)，而对照组(P<；0.0001)则增加了0.67min(0.51)。治疗后各治疗组间的尿路厚度变化无明显差异。63名患者中没有任何一名患者出现不良反应。需要解释长期的术后结果和更多患者的多中心试验数据，以评估横纹括约肌和尿路内注射自体细胞是否可以成为治疗尿失禁的标准治疗方法。
Background Preclinical studies have suggested that transurethral injections of autologous myoblasts can aid in regeneration of the rhabdosphincter, and fibroblasts in reconstruction of the urethral submucosa. We aimed to compare the effectiveness and tolerability of ultrasonography-guided injections of aultologous cells with those of endoscopic injections of Collagen for stress incontinence.Methods Between 2002 and 2004, we recruited 63 eligible women with urinary stress incontinence. 42 of these women were randomly assigned to receive transurethral ultrasonography-guided injections of autologous myoblasts and fibroblasts, and 21 to receive conventional endoscopic injections of collagen. The first primary outcome measure was an incontinence score (range 0-6) based on a 24-hour voiding diary, a 24-hour pad test, and a patient questionnaire. The other primary outcome measures were contractility of the rhabdosphincter and thickness of both the urethra and rhabdosphincter. Analysis was by intention to treat. This trial is registered with Controlled-Trials.com, number CCTNAPN-16630.Findings At 12-months' follow-tip, 38 of the 42 women injected with autologous cells were completely continent, compared with two of the 21 patients given conventional treatment with Collagen. The median incontinence score decreased from a baseline of 6.0 (IQR 6.0-6.0; where 6 represents complete incontinence), to 0 (0-0) for patients treated with autologous cells, and 6.0 (3.5-6.0) for patients treated with Collagen (p < 0.0001). Ultrasonographic measurements showed that the mean thickness of the rhabdosphincter increased from a baseline of 2.13 mm (SD 0.39) for all patients to 3.38 mm (0.26) for patients treated with autologous cells and 2.32 mm (0.44) for patients treated with Collagen (p < 0.0001). Contractility of the rhabdosphincter increased from a baseline of 0.58 mm (SD 0.32) to 1.56 mm (0.28) for patients treated with autologous cells and 0.67 min (0.51) for controls (p < 0.0001). The change in the thickness of the urethra after treatment was not significantly different between treatment groups. No adverse effects were recorded in any of the 63 patients.Interpretation Long-term postoperative results and data from multicentre trials with larger numbers of patients are needed to assess whether injection of autologous cells into the rhabdosphincter and the urethra could become a standard treatment for urinary incontinence.