Obstetrics and Gynecology Department, CHU Nîmes, University of Montpellier, Place du Pr Robert Debré, 30900, Nîmes, France.
Gynecology Department, Jeanne de Flandre Hospital, University of Lille, Lille, France.
Int Urogynecol J. 2022 Jul;33(7):2021-2030. doi: 10.1007/s00192-021-05071-8. Epub 2022 Jan 19.
The main objective of the study was to evaluate the rates of de novo stress urinary (SUI) and postoperative dyspareunia after both sacrocolpopexy/hysteropexy (SCP) and vaginal mesh surgery.
A prospective, multicenter, randomized, open-label study with two parallel groups treated by either SCP or Uphold Lite vaginal mesh was carried out. Study participants were ≥ 50 and < 80 years old patients with Pelvic Organ Prolapse Quantification (POP-Q) stage ≥2 who were considered eligible for reconstructive surgery and who were sexually active with no dyspareunia and free from bothersome SUI at presentation. Women were assessed before surgery and at 4-8 weeks and 11-13 months after using validated measures including POP-Q, Pelvic Floor Disability Index (PFDI-20), Pelvic Floor Impact Questionnaire (PFIQ-7), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR), and Patient Global Impression of Improvement (PGI-I). Data were also collected for health economics evaluation.
Of the required sample of 156 women, 42 women (19 SCP and 23 vaginal mesh) were only recruited owing to the discontinuation of vaginal mesh worldwide. The median follow-up was 376 days. The rates of bothersome de novo SUI were similar in the SCP and Uphold vaginal mesh groups (15.79 vs 15.00%, OR 0.95 [95% CI 0.22-4.14]). Among 30 sexually active patients at follow-up, the rates of women reporting de novo dyspareunia "usually or always" were 6.7% after SCP vs 13.3% after vaginal mesh (p = 1). Health economics evaluation showed a cost saving of 280€ in favor of the Uphold vaginal mesh technique, but no significant difference in the total cost (2,934.97€ for SCP vs 3,053.26€ for Uphold vaginal mesh).
Bothersome de novo SUI and de novo dyspareunia occurred in approximately 15% and 23% of our study cohorts, with no significant difference between sacrocolpopexy/hysteropexy and anterior/apical vaginal mesh surgery. However, these results should be interpreted with caution owing to the small sample size.
本研究的主要目的是评估骶骨阴道固定术/子宫固定术（SCP）和阴道网片手术治疗后新发压力性尿失禁（SUI）和术后性交痛的发生率。
进行了一项前瞻性、多中心、随机、开放标签的研究，将两组患者分别采用 SCP 或 Uphold Lite 阴道网片治疗。研究参与者为年龄≥50 岁且<80 岁、盆腔器官脱垂定量（POP-Q）≥2 期、有重建手术适应证且性生活活跃、无性交痛且术前无明显 SUI 症状的患者。采用经验证的测量方法（包括 POP-Q、盆腔器官脱垂/尿失禁性功能问卷（PISQ-IR））在术前、术后 4-8 周和 11-13 个月对患者进行评估，并在术后 4-8 周和 11-13 个月使用盆腔器官脱垂/尿失禁性功能问卷（PISQ-IR）和患者整体改善印象（PGI-I）。还收集了卫生经济学评估的数据。
由于全球范围内阴道网片的停用，仅招募了所需的 156 名女性中的 42 名（19 名 SCP 和 23 名阴道网片）。中位随访时间为 376 天。SCP 和 Uphold 阴道网片组新发烦扰性 SUI 的发生率相似（15.79% vs 15.00%，OR 0.95[95%CI 0.22-4.14]）。在 30 名随访时仍有性生活的患者中，SCP 后报告新发性交痛“通常或总是”的女性比例为 6.7%，阴道网片后为 13.3%（p=1）。卫生经济学评估显示，Uphold 阴道网片技术具有 280 欧元的成本节约，但总成本无显著差异（SCP 为 2934.97 欧元，Uphold 阴道网片为 3053.26 欧元）。
本研究队列中，约有 15%和 23%的新发烦扰性 SUI 和新发性交痛发生率无显著差异，骶骨阴道固定术/子宫固定术和前/顶阴道网片手术之间无显著差异。然而，由于样本量小，这些结果应谨慎解释。
