Virginia Urology Center for Incontinence and Pelvic Floor Reconstruction, Richmond, Virginia.
Virginia Commonwealth University School of Medicine, Richmond, Virginia.
J Urol. 2014 Feb;191(2):389-94. doi: 10.1016/j.juro.2013.08.023. Epub 2013 Aug 20.
The Elevate® Anterior and Apical Prolapse Repair System is a polypropylene mesh that is anchored through sacrospinous ligament and obturator fascia fixation points. We present a comprehensive evaluation of this prolapse repair system through 2 years with a focus on safety, operative characteristics, and anatomical, subjective and quality of life outcomes.
A total of 42 women underwent repair of stage II or greater anterior/apical compartment prolapse using the repair system, of whom 2 were lost to followup. Anatomical outcomes were assessed using POP-Q (Pelvic Organ Prolapse Quantification) staging. Subjective and quality of life outcomes were assessed by the validated ICIQ (International Consultation on Incontinence Questionnaire)-VS (Vaginal Symptoms), ICIQ-FLUTS (Female Lower Urinary Tract Symptoms) and IIQ-7 (Incontinence Impact Questionnaire-7). Additional outcomes included a 3-day bladder diary and cough test with outcomes assessed preoperatively, at 6 weeks, and at 1 and 2 years.
Mean ± SD blood loss was 93 ± 55 cc and mean operative time was 58 ± 27 minutes. POP-Q points Aa, Ba and C improved from 0.9, 0.8 and -1.3 preoperatively to -2.1, -2.7 and -6.1 cm at 2 years, respectively (each p <0.05). Four patients experienced anatomical recurrence, which was associated in 2 with symptomatic recurrence on the ICIQ-VS. Statistically significant improvements in the ICIQ-VS, ICIQ-FLUTS and IIQ-7 were seen throughout followup. Adverse events included leg pain, vaginal exposure and urinary retention in 1, 2 and 5 patients, respectively.
The Elevate Anterior and Apical Prolapse Repair System was associated with good anatomical restoration and significant improvements in validated symptom and quality of life indexes through 2 years of assessments. Our experience suggests that the system is a safe, effective surgical procedure in appropriately selected patients. Long-term followup is important, given the FDA (Food and Drug Administration) warning regarding the use of surgical mesh in the repair of pelvic organ prolapse.
Elevate® 前壁和顶部脱垂修复系统是一种聚丙烯网片，通过骶棘韧带和闭孔筋膜固定点固定。我们通过 2 年的时间对该脱垂修复系统进行了全面评估，重点关注安全性、手术特点以及解剖学、主观和生活质量结果。
共有 42 名女性接受了该修复系统治疗 II 期或更高级别的前壁/顶部间隔脱垂，其中 2 名失访。使用 POP-Q（盆腔器官脱垂定量）分期评估解剖学结果。通过经过验证的 ICIQ（国际尿失禁咨询问卷）-VS（阴道症状）、ICIQ-FLUTS（女性下尿路症状）和 IIQ-7（尿失禁影响问卷-7）评估主观和生活质量结果。其他结果包括术前、术后 6 周、1 年和 2 年的 3 天膀胱日记和咳嗽试验，并评估其结果。
平均±标准差失血量为 93±55cc，平均手术时间为 58±27 分钟。POP-Q 点 Aa、Ba 和 C 分别从术前的 0.9、0.8 和-1.3 改善至 2 年时的-2.1、-2.7 和-6.1cm（均<0.05）。4 名患者发生解剖学复发，其中 2 名在 ICIQ-VS 上出现症状性复发。在整个随访期间，ICIQ-VS、ICIQ-FLUTS 和 IIQ-7 均显著改善。不良事件包括 1 例腿部疼痛、2 例阴道暴露和 5 例尿潴留。
Elevate 前壁和顶部脱垂修复系统与良好的解剖学恢复以及经过验证的症状和生活质量指标的显著改善相关，这些改善在 2 年的评估中得到了证实。我们的经验表明，该系统在适当选择的患者中是一种安全、有效的手术方法。鉴于 FDA（美国食品和药物管理局）关于在盆腔器官脱垂修复中使用手术网片的警告，长期随访很重要。
