Cooper University Hospital, University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, Camden, New Jersey, USA.
BMC Urol. 2010 Dec 13;10:21. doi: 10.1186/1471-2490-10-21.
A prospective multicenter clinical study was performed to evaluate the safety and efficacy of a bovine dermal graft (Xenform® Matrix, Boston Scientific, Natick, MA, USA) during vaginal reconstructive surgery.
Forty-five women with ICS stage 2 or higher pelvic organ prolapse (POP) were enrolled at 4 centers. POP-Q, pelvic floor function (PFDI-20), sexual function (PISQ-12), and patient satisfaction tools were used to assess subjects at baseline, and at 2 and 6 weeks, and 3, 6 and 12 months post surgery. The significance of symptom score changes at 6 months and 1 year were determined by the t-test for paired data. Forty-three of the 45 patients completed the 12 month study.
The majority of the subjects had cystocele (98%) and/or rectocele (84%) defects at study entry. At 12 months, 74% of the defects had improved to a stage 0 or 1. Mean PFDI-20 scores improved by 72% (p < 0.001) at 12 months, and PISQ-12 scores were maintained during the follow-up period indicating no decline in sexual function. Three subjects experienced one serious adverse event each; one of the adverse events (constipation) was deemed by the study physician to be unrelated to Xenform®. One subject had severe pyelonephritis resulting in dialysis. This subject had a previous history of pyelonephritis, sepsis and acute renal failure. The third subject had a reported recurrent cystocele of moderate severity, possibly related to the device. No graft related erosions or pain lasting more than 30 days were reported. No subjects withdrew due to an adverse event.
This study is the first to investigate the use of Xenform® Matrix in vaginal reconstructive surgery among patients with POP. Significant improvement was maintained at 12 months utilizing both objective and subjective assessment tools, confirming the safety and efficacy of this material in vaginal surgery.
ClinicalTrials.gov NCT01244165.
一项前瞻性多中心临床研究评估了牛真皮基质移植物（Xenform® Matrix，波士顿科学，马萨诸塞州纳提克）在阴道重建手术中的安全性和有效性。
4 个中心共纳入 45 例 ICS 2 期及以上盆腔器官脱垂（POP）患者。POP-Q、盆底功能（PFDI-20）、性功能（PISQ-12）和患者满意度工具用于评估受试者基线、术后 2 周、6 周、3 个月、6 个月和 12 个月时的情况。采用配对 t 检验比较 6 个月和 1 年时症状评分的变化。45 例患者中有 43 例完成了 12 个月的研究。
大多数患者在研究入组时存在阴道前壁膨出（98%）和/或阴道后壁膨出（84%）缺陷。12 个月时，74%的缺陷改善至 0 期或 1 期。PFDI-20 评分在 12 个月时改善 72%（p < 0.001），PISQ-12 评分在随访期间保持稳定，表明性功能无下降。3 例患者各发生 1 例严重不良事件；1 例不良事件（便秘）被研究医生认为与 Xenform®无关。1 例患者发生严重肾盂肾炎，需行透析。该患者既往有肾盂肾炎、脓毒症和急性肾衰竭病史。第 3 例患者报告有中度复发的阴道前壁膨出，可能与该装置有关。无移植物相关侵蚀或持续 30 天以上的疼痛报告。无患者因不良事件退出。
这项研究首次调查了 Xenform® Matrix 在 POP 患者阴道重建手术中的应用。使用客观和主观评估工具均证实 12 个月时保持了显著改善，证实了该材料在阴道手术中的安全性和有效性。
ClinicalTrials.gov NCT01244165。
