Department of Urology, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, Ohio, USA.
Department of Urology, Menoufia University, Shebeen El-Kom, Egypt.
J Biomed Mater Res B Appl Biomater. 2022 Dec;110(12):2676-2685. doi: 10.1002/jbm.b.35120. Epub 2022 Jul 2.
Stress urinary incontinence (SUI) impacts ~1/3 of women over age 50. Negative publicity around PP meshes used in pelvic prolapse repair drives the need for identifying alternative biomaterials for SUI repair. Our study evaluated in vivo response to collagen sling implanted in an ovine model. Electrocompacted collagen threads were filament wound as slings and crosslinked in genipin. Collagen slings were implanted suburethrally mimicking the transvaginal tape technique. Main study groups were: Collagen sling (n = 3, 6 months) and PP sling (n = 3, 6 months). Collagen sling was also tested at 3-weeks (n = 1) to observe early-stage tissue response and 1-year (n = 2) to assess biomaterial longevity in a preliminary capacity. Collagen slings healed to a fibrous ligament texture at 6 months and maintained such texture to 1 year. Histological scoring indicated biocompatible responses to collagen slings with no adverse events. All study groups exhibited complete tissue ingrowth and interstitial de novo collagen deposition at all time points. Collagen threads induced orderly de novo collagen deposition that was aligned along long axes of threads. Tissue infiltrated collagen slings that were explanted at 6 and 12 months presented similar structural strength with native tissues such as vagina and fascia, and PP (Lynx) slings (p > .05). With the limitation of low number of animals per time point in hindsight, this preliminary study justifies evaluation of collagen slings in a larger sample size of animals, particularly to assess persistence of ligamentous tissue response over longer durations than 1-year.
压力性尿失禁（SUI）影响约 1/3 的 50 岁以上女性。用于治疗盆腔脱垂的聚丙烯网片的负面宣传推动了寻找替代生物材料治疗 SUI 的需求。我们的研究评估了胶原蛋白吊带在绵羊模型中的体内反应。电压实胶原线被制成吊带并通过京尼平交联。胶原蛋白吊带被植入尿道下以模拟经阴道吊带技术。主要研究组为：胶原蛋白吊带（n=3，6 个月）和聚丙烯吊带（n=3，6 个月）。还在 3 周时（n=1）测试了胶原蛋白吊带，以观察早期组织反应，在 1 年时（n=2）初步评估生物材料的耐久性。胶原蛋白吊带在 6 个月时愈合为纤维状韧带组织，并在 1 年内保持这种结构。组织学评分表明胶原蛋白吊带具有生物相容性，无不良反应。所有研究组在所有时间点均表现出完全的组织内生长和间质新生胶原沉积。胶原蛋白线诱导有序的新生胶原沉积，沿线的长轴排列。在 6 个月和 12 个月时取出的组织浸润的胶原蛋白吊带与阴道和筋膜等天然组织以及聚丙烯（Lynx）吊带（p＞.05）具有相似的结构强度。回顾性地考虑到每个时间点动物数量较少的局限性，这项初步研究证明了在更大样本量的动物中评估胶原蛋白吊带的合理性，特别是要评估韧带组织反应在 1 年以上的持续时间。
