Abstract
BACKGROUND: Native tissue repair surgery for pelvic organ prolapse is associated with a high recurrence rate, and accumulating evidence has highlighted adverse events related to mesh use. This study aimed to assess the efficacy and safety of a modified paravaginal repair technique combined with sacrospinous ligament suspension for treating pelvic organ prolapse. METHODS: This randomized, non-inferiority, endpoint assessor-blinded study included patients with pelvic organ prolapse. Participants were assigned to either the intervention group, who underwent the modified paravaginal repair with sacrospinous ligament suspension (MPVR-SSL), or the control group, who received laparoscopic sacrocolpopexy (LSC). Postoperative follow-up continued for 1 year. RESULTS: Among the 173 patients evaluated for eligibility, 160 were enrolled, while 13 were excluded. Of those enrolled, 80 were randomized to each group. At the 12-month follow-up, five patients in the MPVR-SSL group and four in the LSC group were lost to follow-up. Success rates at 12 months were 98.7% (75/76) in the LSC group and 97.3% (73/75) in the MPVR-SSL group, and no significant difference was found between them ( P = 0.552). No cases of ureteral injury, cystotomy/urethral injury, bowel injury, vascular injury, nerve injury, deep vein thrombosis, or pulmonary embolism were identified in the MPVR-SSL group. A few cases of vaginal bleeding, granulation, or fallopian tube prolapse occurred. Neuromuscular pain was more frequent in the MPVR-SSL group than in the LSC group (13 vs. 3, P = 0.008). However, all patients experienced symptom resolution within 3 months. CONCLUSION: The MPVR-SSL proved to be an effective and safe approach for treating pelvic organ prolapse.