Modified single-port laparoscopic lateral suspension with bilateral 2-mm micropunctures for moderate-to-severe pelvic organ prolapse: a prospective single-arm feasibility study

Pelvic organ prolapse (POP) affects up to 40% of women over 50 years, with traditional surgical approaches carrying significant morbidity. We evaluated the feasibility and preliminary safety and efficacy of a modified single-port laparoscopic lateral suspension (LLS) technique using bilateral 2-mm micropunctures for moderate-to-severe POP. This prospective, single-arm feasibility study enrolled women aged 40–75 years with symptomatic POP-Q stage III–IV prolapse between January 2022 and December 2023. Note: this trial was retrospectively registered (ChiCTR2600118158, February 2, 2026). The primary endpoint was 12-month anatomical success rate (POP-Q ≤ stage I) among per-protocol completers. Sensitivity analyses addressed attrition bias. Sixty patients were enrolled; 51 underwent surgery (85%). Thirty-eight patients completed 12-month follow-up (74.5% retention rate; planned evaluable sample: 50 patients not achieved). In the per-protocol analysis, the primary endpoint was achieved in 36/38 patients (94.7%; 95% CI: 82.7%–99.0%). In a conservative worst-case sensitivity analysis (all 13 dropouts classified as failures), the success rate was 70.6% (95% CI: 57.3%–81.6%; 36/51), which did not exceed the pre-stated 80% threshold. Mean operative time was 141.6 ± 19.5 min with no conversions. PFDI-20 improved from 210.5 ± 14.2 at baseline to 51.2 ± 12.6 at 12 months. Patient-reported cosmetic scores (POSAS) were 17.0 ± 6.4 at 12 months. Mesh-related pain occurred in 7.8% and incisional hernia in 5.9% of operated patients, representing clinically important safety signals that require longer follow-up and comparative data for full evaluation. This single-arm feasibility study suggests that modified single-port LLS with bilateral 2-mm micropunctures is technically feasible and has a potentially favorable safety for moderate-to-severe POP with favorable cosmetic outcomes, warranting prospective comparative evaluation. However, the retrospective trial registration, failure to achieve the planned evaluable sample size, substantial attrition, and uncontrolled design substantially limit the strength of conclusions. These preliminary findings require confirmation in prospective randomized controlled trials. trial registration Chinese Clinical Trial Registry: ChiCTR2600118158 (retrospectively registered February 2, 2026). Note: registration occurred after completion of patient recruitment and primary follow-up.