A Retrospective Cohort Study of Bilateral Sacrospinous Ligament Fixation Over a Decade of Clinical Experience.

Abstract

<h4>Introduction and hypothesis</h4>Bilateral sacrospinous ligament fixation (BSSLF) is a well-established procedure for apical prolapse repair, yet surgical approaches and outcomes vary. This study presents the first large-cohort, long-term retrospective evaluation of BSSLF using the sling-like mesh Splentis®. We analyse anterior BSSLF (ABSSLF) outcomes without total hysterectomy and compare them with other surgical approaches used in clinical practice.<h4>Methods</h4>A total of 391 patients treated with Splentis between 2012 and 2023 at two referral centres were stratified into group A (ABSSLF without total hysterectomy, n = 248) and group B (other approaches including posterior fixation and/or total hysterectomy, n = 143). Outcomes were evaluated at intermediate (1-3 years, n = 256) and long-term follow-up (> 3 years, n = 135). Primary endpoint was composite cure: Pelvic Organ Prolapse Quantification (POP-Q) point C < 0, absence of bulge symptoms and no retreatment. Secondary endpoints included POP-Q changes, patient-reported symptoms and complications.<h4>Results</h4>Overall cure was 90.3% (95% CI 86.9-93.0%): group A, 94.3% (95% CI 90.7-96.9%); group B, 83.2% (95% CI 76.1-88.9%). Group A remained stable at long-term follow-up, whereas group B declined by 16.2 percentage points. Omission of concomitant anterior colporrhaphy was associated with higher odds of treatment failure (OR 3.0, 95% CI 1.3-6.8; p = 0.010). Most complications were Clavien-Dindo ≤ II. Mesh-related complications were 4.8% (95% CI 2.5-8.3%) in group A and 5.6% (95% CI 2.4-10.7%) in group B.<h4>Conclusions</h4>The ABSSLF procedure using Splentis showed high long-term effectiveness when used for hysteropexy or cervicopexy, that is, without prior/concomitant total hysterectomy. Other approaches showed lower yet favourable outcomes, highlighting the versatility of the device and the importance of patient selection.