Department of Obstetrics & Gynecology, University of British Columbia, Vancouver, Canada.
St Mary's Research Centre, Montreal, Quebec, Canada.
PLoS One. 2024 Oct 24;19(10):e0308926. doi: 10.1371/journal.pone.0308926. eCollection 2024.
Pelvic organ prolapse (POP) increases in incidence and severity with aging. At least 1 in 4 women seek pelvic floor care and many more suffer with concurrent symptoms of bowel, bladder and sexual dysfunction, which can have a large impact on quality of life. It is estimated that 1 in 5 women will undergo surgery for POP. POP is difficult to cure with existing surgeries and therefore treatment failure and reoperations are common. Surgical innovation in this area is urgently needed and we have developed a novel technique of bilateral sacrospinous vaginal vault fixation with synthetic mesh arms (BSSVF-M). Based on preliminary studies it may be more successful, durable and cost-effective than standard sacrospinous ligament suspension with sutures (SSLS). Preliminary development and exploration studies showed safety and efficacy of BSSVF-M. Following an established framework for research in surgical innovations, we now wish to conduct a randomized comparative effectiveness trial for assessment of this novel technique.
This is a multi-center randomized controlled trial in Canada comparing the surgical techniques of BSSVF-M vs. SSLS to address apical prolapse. In total, 358 women with symptomatic POP at five centers will be randomized with 80% power to detect a 15% difference in primary composite outcome and accounting for a 15% loss to follow-up over 2 years. The primary objective is to investigate BSSVF-M vs. SSLS using an established composite of 3 objective signs and 1 subjective symptom of POP measured 2 years postoperatively. Secondary objectives: 1) To determine changes in condition-specific pelvic symptoms, quality of life, pain and condition-specific body image post BSSVF-M vs. SSLS using validated questionnaires; 2) To determine changes in sexuality post BSSVF-M vs. SSLS; 3) To determine global impression of improvement, adverse events (validated classification scheme), reoperations and health utility post BSSVF-M vs. SSLS; 4) To determine the cost-effectiveness of BSSVF-M vs SSLS. Study Registration at clinicaltrials.gov (NCT02965313).
There is a need for innovation to improve the surgical approach to vaginal apical suspension. Despite controversies with mesh, it has been shown to be safe when used appropriately and to have higher durability when compared with sutures. As well, the importance of restoring anatomy and tension-free surgical approach in pelvic reconstructive surgery has led to better long-term outcomes and fewer side effects. These principles have been applied when developing the novel BSSVF-M technique. Anticipated challenges of this trial include recruitment, compliance problems and loss to follow up However, the robust methodology will provide evidence on the best surgical approach to correct POP, a common condition among aging women.
盆腔器官脱垂（POP）随着年龄的增长而发病率和严重程度增加。至少有 1/4 的女性寻求盆底护理，更多的女性同时患有肠、膀胱和性功能障碍的并发症状，这会对生活质量产生重大影响。据估计，1/5 的女性将接受 POP 手术。现有的手术很难治愈 POP，因此治疗失败和再次手术很常见。该领域急需手术创新，我们开发了一种带有合成网臂的双侧骶棘韧带阴道穹窿固定术（BSSVF-M）的新技术。基于初步研究，与缝线的标准骶棘韧带悬吊术（SSLS）相比，它可能更成功、更持久且更具成本效益。BSSVF-M 的初步开发和探索性研究显示了安全性和有效性。在既定的外科创新研究框架下，我们现在希望进行一项随机对照有效性试验，以评估该新技术。
这是在加拿大进行的一项多中心随机对照试验，比较了 BSSVF-M 与 SSLS 两种手术技术，以解决顶端脱垂问题。在五个中心，共有 358 名有症状的 POP 女性将以 80%的功效进行随机分组，以检测术后 2 年主要复合结局的 15%差异，并考虑到 15%的随访损失。主要目的是使用术后 2 年测量的 3 个客观 POP 体征和 1 个主观 POP 症状的既定综合标准，来研究 BSSVF-M 与 SSLS。次要目标：1）使用经过验证的问卷确定 BSSVF-M 与 SSLS 后特定于骨盆的症状、生活质量、疼痛和特定于骨盆的身体形象的变化；2）确定 BSSVF-M 与 SSLS 后性功能的变化；3）确定 BSSVF-M 与 SSLS 后总体改善印象、不良事件（经验证的分类方案）、再次手术和健康效用的变化；4）确定 BSSVF-M 与 SSLS 的成本效益。该研究已在 clinicaltrials.gov（NCT02965313）注册。
需要创新来改善阴道顶端悬吊的手术方法。尽管存在与网片相关的争议，但当网片使用得当时，它被证明是安全的，并且与缝线相比，其耐用性更高。此外，在盆腔重建手术中恢复解剖结构和无张力手术方法的重要性导致了更好的长期结局和更少的副作用。在开发新型 BSSVF-M 技术时，应用了这些原则。预计该试验将面临招募、依从性问题和随访丢失等挑战。然而，稳健的方法学将为纠正 POP 的最佳手术方法提供证据，POP 是老年女性的常见病症。
