NOTES sacrocolpopexy versus sacrospinous ligament fixation for apical pelvic organ prolapse: a pilot, hypothesis-generating, single-centre retrospective comparative cohort study.

BACKGROUND: To compare anatomical, functional, and safety outcomes of vaginal natural orifice transluminal endoscopic surgery (vNOTES) sacrocolpopexy (SCP) and vNOTES sacrospinous ligament fixation (SSLF) for apical pelvic organ prolapse (POP). METHODS: Single-centre, single-surgeon, retrospective comparative cohort study conducted in accordance with the STROBE statement. Allocation to vNOTES SSLF (n = 24) or vNOTES SCP with a lightweight polypropylene Y-mesh (n = 32) was based on prespecified intra-operative feasibility criteria rather than randomisation. The primary outcome was composite apical anatomical success at 12 months (point C ≤ -5 cm and absence of apical POP-Q stage ≥ II). Secondary outcomes included perioperative parameters, visual analogue scale (VAS) pain scores, Quality-of-Recovery-40 (QoR-40), Prolapse Quality-of-Life (P-QOL), ICIQ-UI SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form) and PGI-I scores, and complications classified with the Clavien-Dindo and IUGA/ICS Category-Time-Site systems. RESULTS: Baseline characteristics were balanced. Composite apical success at 12 months was achieved in 22/24 (91.7%) SSLF patients and 30/32 (93.8%) SCP patients (risk difference -2.1 percentage points; 95% CI, -17.6 to +13.5); this interval is compatible with clinically meaningful differences in either direction and does not support an inference of equivalence. Suspension time was shorter with SSLF (40.2 ± 11.8 vs 54.6 ± 12.7 min; p < 0.001), as was total operative time (89.7 ± 15.2 vs 104.9 ± 17.6 min; p = 0.001). Estimated blood loss, VAS pain, QoR-40, P-QOL, ICIQ-UI SF and PGI-I showed no statistically detectable difference. No intra-operative injuries, conversions to laparotomy, or mesh-related events (IUGA/ICS classification) were detected during a median follow-up of 21 months (range 6-36) for SSLF and 20 months (8-35) for SCP. CONCLUSIONS: In this hypothesis-generating single-surgeon cohort, vNOTES SSLF and vNOTES SCP showed no statistically detectable difference in short- to mid-term anatomical and patient-reported outcomes, with shorter suspension time favouring SSLF.