Bilateral Sacrospinous Fixation Using a Sling-Like Mesh: Real-World Data on Early Safety and Surgical Outcomes from a Large Cohort
Year: 2026
Type: article
Study design: Observational Study
Abstract: Introduction and Hypothesis To describe early safety and feasibility data of Anterior Bilateral Sacrospinous Ligament Fixation (ABSSLF) using Splentis® for apical Pelvic Organ Prolapse (POP). Methods Retrospective analysis of available data from 334 women treated with Splentis between 2016–2023 at a German referral hospital. Proportions of early complications and outcomes are reported with Clopper–Pearson 95% confidence intervals. Anatomical changes (POP-Q stages) and patient-reported outcomes (German Pelvic Floor Questionnaire, gPFQ) were explored with Wilcoxon test. Results The median operative time was 19 min (IQR 16–24). Perioperative complications include 0.3% intraoperative bleeding > 200 mL, 43.1% mild and 0.3% moderate gluteal pain (Clavien–Dindo grade I); 1.2% urinary retention (Clavien–Dindo grade II). At median follow-up of 11.3 weeks (IQR 8.9–13.8), 7.2% (95%CI 4.7–10.5%) reported mild and 0.6% (95%CI 0.1–2.1%) moderate gluteal pain (Clavien–Dindo grade I), and 0.9% de novo residual urine > 100 mL (Clavien–Dindo grade I). Early mesh-related complications included three cases requiring partial removal (0.9%, Clavien–Dindo grade IIIa), and one managed conservatively (0.3%, Clavien–Dindo grade I); 98.8% (95% CI 97.0–99.7%) showed apical POP-Q ≤ 1 (median improvement –3.0, 95%CI –3.0 to –2.5; p < 0.0001), with improvements in anterior and posterior compartments. Patient satisfaction was 97.9% (95% CI 95.7–99.1%). Moreover, 115/334 patients (34.4%) completed the gPFQ, and pelvic floor function improved by median 7.4 points (95%CI 6.5–8.3; p < 0.0001). Conclusions ABSSLF with Splentis demonstrated favourable perioperative safety and encouraging short-term outcomes, with a low rate of early complications, as a uterus-preserving option for apical POP. Long-term studies are needed to assess effectiveness and late complications.
Institutions: Düsseldorf University Hospital, Helios Klinikum Erfurt
Language: English
Subfield: Urology
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W4415902332