A novel bilateral anterior sacrospinous hysteropexy technique for apical pelvic organ prolapse repair via the vaginal route: a cohort study

Abstract

Background Uterine-preserving techniques are becoming increasingly popular in the last decade. This investigation evaluates a novel hysteropexy technique using a mesh in sling-alike configuration [Splentis (Promedon, Argentina)] which is attached anteriorly to the cervix and suspended to the sacrospinous ligaments bilaterally via the vaginal route in women undergoing surgery for uterine prolapse. Methods This was a single-center cohort study, evaluating women who underwent transvaginal hysteropexy with Splentis for primary uterine descent. Data have been collected prospectively as part of the quality assurance system. Primary endpoint was treatment success, defined as a combined endpoint including the absence of a vaginal bulge symptom and no retreatment of apical prolapse. A validated questionnaire to evaluate quality-of-life and prolapse symptoms was utilized. Descriptive analysis was applied. Wilcoxon signed-rank test was performed to compare paired samples. The significance level was set at 5%. Results A total of 103 women with a median age of 68.0 [IQR 11.5] years with a median apical POP-Q stage of 3 were included. The median surgery time was 22 [IQR 12] minutes and no intraoperative complication occurred. After a median follow-up time of 17 months, treatment success was achieved in 91 (89.2%) patients and quality of life and patient report outcomes improved significantly (p < 0.001). Mesh exposure occurred in 3 (2.9%) patients. Of these, two patients required surgical revision, and one patient was treated conservatively. One patient required partial mesh removal due to dyspareunia. Conclusion Bilateral sacrospinous hysteropexy with Splentis offers an efficacious and safe alternative for apical compartment repair, incorporating the advantages of pelvic floor reconstruction via the vaginal route.

Trends in Urogynecology—Transvaginal Mesh Surgery in Germany

“…Consequently, the rates of apical prolapse repair through sacrocolpopexy have steadily increased over the last two decades [40,41]. However, despite this trend, the continuous evolution of corresponding products and the option of uterinepreserving surgery with transvaginal mesh, among other vaginal approaches showing over 85% success rates [13], positions the TVM procedure as an option for uterine preservation among women over 50 years.…”

“…However, in response to the escalating trend in transvaginal mesh surgery and the increasing complication rates linked to mesh implants, the FDA issued consecutive warnings in 2008 and 2011 [11,12]. In 2016, the FDA categorized vaginal mesh products as high-risk (class III) and eventually prohibited their sale in 2019 [13].…”

“…Over the past two decades, meshes for transvaginal repair of POP have become increasingly controversial. However, in contrast to the FDA, the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), European Urology Association (EAU), European Urogynaecological Association (EUGA), and American Urogynecologic Society have issued positive statements endorsing the use of transvaginal meshes for treating urinary incontinence and pelvic organ prolapse [13]. According to their statements, TVM repair remains a crucial treatment option for POP, and numerous mesh devices designed for POP treatment remain available worldwide.…”