Hysteropexy in the treatment of uterine prolapse stage 2 or higher: laparoscopic sacrohysteropexy versus sacrospinous hysteropexy. A multicentre randomised controlled trial (LAVA trial).

OBJECTIVE: To investigate whether laparoscopic sacrohysteropexy (LSH) is non-inferior to vaginal sacrospinous hysteropexy (SSHP) in the surgical treatment of uterine prolapse. DESIGN: Multicentre randomised controlled non-blinded non-inferiority trial. SETTING: 5 non-university teaching hospitals in the Netherlands, one university hospital in Belgium. POPULATION: 126 women with uterine prolapse stage 2 or higher undergoing surgery without previous pelvic floor surgery. METHODS: Randomisation in a 1:1 ratio to LSH or SSHP, stratified per centre and severity of the uterine prolapse. The predefined inferiority margin was an increase in surgical failure rate of 10%. MAIN OUTCOME MEASURES: Primary outcome was surgical failure, defined as reoccurrence of uterine prolapse (POP-Q >/= 2) with bothersome bulging/protrusion symptoms and/or repeat surgery or pessary at 12 months postoperative. Secondary outcomes were anatomical recurrence (any compartment), functional outcome and quality of life. RESULTS: LSH was non-inferior for surgical failure (n=1, 1.6%) compared with SSHP (n=2, 3.3%, difference -1.7%, 95% CI -7.1 to 3.7) 12 months postoperatively. Overall anatomical recurrences and quality of life did not differ. More bothersome symptoms of overactive bladder (OAB) and faecal incontinence were reported after LSH. Dyspareunia was more frequently reported after SSHP. CONCLUSION: LSH was non-inferior to SSHP for surgical failure of the apical compartment at 12 months' follow-up. Following LSH, bothersome OAB and faecal incontinence were more frequent, yet dyspareunia was less frequent.