Abstract
BackgroundUterine-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.MethodsThis 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%.ResultsA 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.ConclusionBilateral 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.
Highlights
Uterine-preserving techniques are becoming increasingly popular in the last decade
The protocol was approved by the ethics committee of the medical association of Thuringia, Germany, informed consent was obtained by the patients and the trial has been registered at the German Clincial Trials Register prior to patient recruitment
Treatment success was defined as a combined endpoint [9] including the patient reported outcome of absence of a vaginal bulge symptom and no need for surgical or conservative retreatment for apical POP
Summary
Pelvic organ prolapse (POP) is defined as a downward descent of the pelvic organs that results in protrusion of the vagina, uterus, or both [1] It is a common condition, with a prevalence of approximately 30–40% [2] and a lifetime risk of undergoing surgery for POP of 10–20% [3]. Splentis (Promedon, Cordoba, Argentina) is a lightweight, type I polypropylene mesh used in uterine-preserving techniques via the vaginal route for women with apical POP. It is designed in a sling-alike configuration; the mesh is fixed anteriorly to the cervix and suspended to the sacrospinous ligaments (SSLs) bilaterally. The present study was performed to evaluate the efficacy and safety of vaginal sacrospinous hysteropexy using Splentis in women undergoing primary surgery for uterine descent
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