Department of Urology, Lukas Hospital, Neuss, Germany.
University Hospital for Urology, Klinikum Oldenburg, School of Medicine and Health Sciences, Carl von Ossietzky University Oldenburg, Germany.
Int J Surg. 2017 Mar;39:249-254. doi: 10.1016/j.ijsu.2017.02.006. Epub 2017 Feb 10.
Optimized biocompatibility of new materials is a major requirement for transvaginal meshes for pelvic organ prolapse (POP) repair. Polyvinylidene fluoride (PVDF) presented good characteristics in prior animal experiments and clinical use in humans.
Between 01/2012 and 04/2016 37 women underwent transvaginal repair of symptomatic prolapse of the anterior vaginal wall (cystocele) with PVDF-mesh in a single institution. A chart review for recurrence, continence, peri- and early postoperative complications was performed. Referring practitioners were interviewed by telephone and mail. Additionally patient reported outcome and satisfaction were measured by Patient Global Improvement Inventory (PGI-I) scale.
34 women were eligible for a mean follow up of 19 months. The functional outcome improved significantly. One symptomatic vault prolapse (2.9%) and two reoperations for incontinence (5.9%) occurred. Two mesh exposures (5.9%) occurred and were treated conservatively. No other severe complications were registered. 87.5% of treated women felt very much better or much better and would undergo the surgery again. A cohort study including development steps in accordance with the IDEAL system is presented.
For the first time we report on effectivity and safety of transvaginal application of PVDF-mesh in real-life practice. A prospective long-term evaluation in a registry is justified.
优化新材料的生物相容性是用于治疗盆腔器官脱垂（POP）修复的经阴道网片的主要要求。聚偏二氟乙烯（PVDF）在先前的动物实验和人体临床应用中表现出良好的特性。
在 2012 年 1 月至 2016 年 4 月期间，在一家机构中，37 名女性接受了经阴道修补术，以治疗前阴道壁（膀胱膨出）的症状性脱垂。对复发、控尿、围手术期和早期术后并发症进行了图表回顾。通过电话和邮件对转诊医生进行了访谈。此外，通过患者整体改善量表（PGI-I）测量了患者报告的结果和满意度。
34 名女性符合平均随访 19 个月的条件。功能结果显著改善。发生 1 例有症状的穹窿脱垂（2.9%）和 2 例因失禁再次手术（5.9%）。发生 2 例网片暴露（5.9%），并保守治疗。未登记其他严重并发症。87.5%的治疗女性感觉非常好或好很多，并会再次接受手术。介绍了一个包括根据 IDEAL 系统进行的发展步骤的队列研究。
我们首次报告了经阴道应用 PVDF 网片在真实实践中的有效性和安全性。在注册处进行前瞻性长期评估是合理的。
