Altman Daniel, Väyrynen Tapio, Engh Marie Ellström, Axelsen Susanne, Falconer Christian
Division of Obstetrics and Gynecology, Department of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, 182 88 Stockholm, Sweden.
Int Urogynecol J Pelvic Floor Dysfunct. 2008 Jun;19(6):787-93. doi: 10.1007/s00192-007-0526-2.
The objective of this study is to report on shortterm outcomes after pelvic organ prolapse repair using Prolift transvaginal mesh. A 3-year multicenter prospective cohort study was performed in 28 centers. Assessment preoperatively and at 2 months postoperatively included the condition-specific pelvic organ prolapse quantification system (POP-Q) and a macroscopic inflammatory scale. Subjective outcome was measured using the urogenital distress inventory (UDI) and the incontinence impact questionnaire (IIQ-7). Surgical characteristics and adverse events during follow-up were registered in a separate protocol. The evaluation is based on the interim safety analysis and includes 2-month evaluations of 123 cases. Pelvic organ perforation occurred in four cases (3.2%), three bladder injuries and one case of rectal perforation. At the 2-month follow-up, there were two cases of mesh exposure, an increase of mild-moderate granuloma formation in the operated areas (P < 0.003) but no cases of serious adverse tissue reactions related to the polypropylene mesh. Postoperative anatomical cure (defined as POP-Q stage 0-1) was 87% after anterior repair, 91% after posterior repair and 88% after total repair. All quality of life aspects measured by the IIQ-7 improved 2 months after surgery. Pelvic heaviness, vaginal bulging, and vaginal protrusion all decreased considerably (P < 0.001). There was also a significant improvement in several lower urinary tract symptoms and a decreased need for manually assisted defecation. This first report from an ongoing multicenter study suggests that transvaginal mesh surgery with the Prolift system is associated with satisfactory outcomes 2 months after surgery. There were no severe adverse events attributed to the polypropylene mesh.
本研究的目的是报告使用Prolift经阴道网片进行盆腔器官脱垂修复后的短期结局。在28个中心开展了一项为期3年的多中心前瞻性队列研究。术前及术后2个月的评估包括特定病情的盆腔器官脱垂量化系统（POP-Q）和宏观炎症量表。使用泌尿生殖系统困扰量表（UDI）和尿失禁影响问卷（IIQ-7）来衡量主观结局。随访期间的手术特征和不良事件记录在单独的方案中。该评估基于中期安全性分析，包括对123例患者的2个月评估。发生4例盆腔器官穿孔（3.2%），其中3例膀胱损伤，1例直肠穿孔。在2个月的随访中，有2例网片暴露，手术区域轻度至中度肉芽肿形成有所增加（P<0.003），但未出现与聚丙烯网片相关的严重不良组织反应病例。前壁修复术后解剖学治愈（定义为POP-Q 0-1期）为87%，后壁修复术后为91%，全盆底修复术后为88%。IIQ-7所衡量的所有生活质量方面在术后2个月均有所改善。盆腔坠胀感、阴道膨出和阴道脱垂均显著减轻（P<0.001）。几种下尿路症状也有显著改善，人工辅助排便的需求减少。这项正在进行的多中心研究的首份报告表明，使用Prolift系统的经阴道网片手术在术后2个月时结局令人满意。未出现归因于聚丙烯网片的严重不良事件。
