Miller Dennis, Lucente Vincent, Babin Elizabeth, Beach Patricia, Jones Peter, Robinson David
From the *Milwaukee Urogynecology; Wheaton Medical Group; †Institute for Female Pelvic Medicine and Reproductive Surgery; ‡Lincoln Center OB/GYN Wauwatosa, WI; and §Ethicon, Inc, Somerville, NJ.
Female Pelvic Med Reconstr Surg. 2011 May;17(3):139-43. doi: 10.1097/SPV.0b013e3182175da6.
: The objective of the study was to assess the effectiveness and complication rates for the transvaginal (TVM) technique in the treatment of pelvic organ prolapse (POP).
: Women with symptomatic POP (POP-Q stage II-IV) were invited to participate in this institutional review board-approved 5-year study at 3 US centers. All enrolled patients underwent prolapse repair surgery with GYNEMESH PS Prolene Nonabsorbable Soft Mesh using the TVM technique. Success was defined as International Continence Society (ICS) POP-Q stage I or less. The Prolapse-Specific Inventory and quality-of-life questionnaire was used as a subjective outcome measure.
: Eighty-five women were included. Sixty-six patients were available for follow-up at 5 years. Overall anatomic success rates were 88% (90% confidence interval [CI], 80%-93%), 69% (90% CI, 59%-78%), and 67% (95% CI, 56%-76%) at 1, 3, and 5 years, respectively. Anatomic success rates in treated compartments were 89% (90% CI, 82%-94%), 76% (90% CI, 66%-84%), and 77% (90% CI, 67%-85%) at 1, 3, and 5 years, respectively. When defined as treated side leading edge above the hymen, success rates were 89% at 5 years. Five patients required reoperation for prolapse by 5 years. Statistically significant improvements in quality-of-life and Prolapse-Specific Inventory scores were sustained over 5 years. Mesh exposure was observed in 16 of 85 patients over the 5 years. Nine required partial mesh excision. There were 3 patients with some degree of dyspareunia, reported between 3 and 5 years, whereas in 8, preexisting dyspareunia resolved. There was 1 rectovaginal fistula reported and 2 reported ureteral injuries, one of which resulted in a ureteral-vaginal fistula; all resolved after repair.
: Five-year results indicated that TVM provided a stable anatomic repair. Improvements in quality of life and associated improvements in specific prolapse symptoms were sustained over the 5-year period. Mesh exposure was the most common complication.
本研究的目的是评估经阴道（TVM）技术治疗盆腔器官脱垂（POP）的有效性和并发症发生率。
有症状的POP（POP-Q分期II-IV期）女性受邀参加美国3个中心的这项经机构审查委员会批准的5年研究。所有入组患者均采用TVM技术使用GYNEMESH PS普理灵不可吸收软质补片进行脱垂修复手术。成功定义为国际尿控协会（ICS）POP-Q分期为I期或更低。脱垂特异性量表和生活质量问卷用作主观结局指标。
纳入85名女性。66例患者可进行5年随访。1年、3年和5年时的总体解剖学成功率分别为88%（90%置信区间[CI]，80%-93%）、69%（90%CI，59%-78%）和67%（95%CI，56%-76%）。治疗部位的解剖学成功率在1年、3年和5年时分别为89%（90%CI，82%-94%）、76%（90%CI，66%-84%）和77%（90%CI，67%-85%）。当定义为治疗侧前缘位于处女膜上方时，5年时成功率为89%。5名患者在5年时因脱垂需要再次手术。生活质量和脱垂特异性量表评分在5年期间持续有统计学意义的改善。5年期间85例患者中有16例观察到补片暴露。9例需要部分补片切除。3例患者在3至5年期间报告有某种程度的性交困难，而8例既往存在的性交困难得到缓解。报告有1例直肠阴道瘘和2例输尿管损伤，其中1例导致输尿管阴道瘘；所有病例修复后均痊愈。
5年结果表明TVM提供了稳定的解剖学修复。生活质量的改善以及相关脱垂症状的改善在5年期间持续存在。补片暴露是最常见的并发症。
