Milani Alfredo L, Damoiseaux Anne, IntHout Joanna, Kluivers Kirsten B, Withagen Mariella I J
Department of Obstetrics & Gynecology, Reinier de Graaf Hospital, P.O. Box 5011, 2600, GA, Delft, The Netherlands.
Department of Obstetrics & Gynecology, Catharina Hospital, P.O. Box 1350, 5602, ZA, Eindhoven, The Netherlands.
Int Urogynecol J. 2018 Jun;29(6):847-858. doi: 10.1007/s00192-017-3512-3. Epub 2017 Nov 22.
Our aim was to evaluate clinically relevant long-term outcomes of transvaginal mesh or native tissue repair in women with recurrent pelvic organ prolapse (POP).
We performed a 7-year follow-up of a randomized controlled trial on trocar-guided mesh placement or native tissue repair in women with recurrent POP. Primary outcome was composite success, defined as absence of POP beyond the hymen, absence of bulge symptoms, and absence of retreatment for POP. Secondary outcomes were adverse events, pain, and dyspareunia. Multiple imputation was used for missing data of composite success and pain; estimates are presented with 95% confidence intervals (CI).
Between August 2006 and July 2008, 194 women were randomized; 190 underwent surgery. At 7 years, 142 (75%) were available for analysis, of whom, the primary outcome could be calculated in 127. Composite success was 53% (95% CI 41, 66) for mesh and 54% (95% CI 42, 65) for native tissue. Repeat surgery for POP was 25% for mesh and 16% for native tissue (difference 9%; 95% CI -5, 23) and occurred in untreated compartments in the mesh group and treated compartments in the native tissue group. Mesh exposure rate was 42%; pain with mesh 39% and native tissue 50% (difference - 11%, 95% CI -27, 6); dyspareunia with mesh 20% and native tissue 17% (difference 3%, 95% CI -9, 17).
Seven-year composite success rates appeared similar for mesh and native tissue. Mesh did not reduce long-term repeat surgery rates due to de novo POP in nonmesh-treated vaginal compartments. Mesh exposure rates were high, though significant differences in pain and dyspareunia were not detected.
ClinicalTrials.gov , NCT00372190.
我们的目的是评估复发性盆腔器官脱垂（POP）女性经阴道植入网片或使用自体组织修复的临床相关长期结局。
我们对一项关于复发性POP女性的套管针引导下网片植入或自体组织修复的随机对照试验进行了7年随访。主要结局为综合成功，定义为处女膜外无POP、无膨出症状且无需再次治疗POP。次要结局为不良事件、疼痛和性交困难。对综合成功和疼痛的缺失数据采用多重填补法；结果以95%置信区间（CI）呈现。
2006年8月至2008年7月期间，194名女性被随机分组；190名接受了手术。7年时，142名（75%）可用于分析，其中127名可计算主要结局。网片组综合成功率为53%（95%CI 41，66），自体组织组为54%（95%CI 42，65）。网片组因POP再次手术率为25%，自体组织组为16%（差异9%；95%CI -5，23），网片组再次手术发生在未治疗的腔室，自体组织组发生在已治疗的腔室。网片暴露率为42%；使用网片疼痛发生率为39%，自体组织为50%（差异 -11%，95%CI -27，6）；使用网片性交困难发生率为20%，自体组织为17%（差异3%，95%CI -9，17）。
网片和自体组织的7年综合成功率似乎相似。网片并未降低非网片治疗阴道腔室因新发POP导致的长期再次手术率。网片暴露率较高，尽管在疼痛和性交困难方面未检测到显著差异。
ClinicalTrials.gov，NCT00372190
