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

Abstract

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 Five 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 recurrence of uterine prolapse (POP‐Q ≥ 2) with bothersome bulging/protrusion symptoms and/or repeat surgery or pessary at 12 months postoperatively. Secondary outcomes were anatomical recurrence (any compartment), functional outcome and quality of life. Results Laparoscopic sacrohysteropexy 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 Laparoscopic sacrohysteropexy 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, but dyspareunia was less frequent. Tweetable abstract Laparoscopic sacrohysteropexy and vaginal sacrospinous hysteropexy have equally good short‐term outcomes.

Comparison of the effectiveness of sacrospinous ligament fixation and sacrocolpopexy: a meta-analysis

“…Fifteen studies including 4,120 cases (2,409 cases for SSLF, 1,439 cases for ASC, and 272 cases for LSC) fulfilled the inclusion criteria and were included in the final analysis (Fig. 1) [14][15][16][17][18][19][20][21][22][23][24][25][26][27][28]. All publications were full-text articles.…”

“…The characteristics of the studies included are shown in Table 1. There were 5 RCTs [14,20,21,25,28] (level of evidence: 2b) [29]; 8 retrospective studies [15,16,18,19,22,24,26,27] and 2 prospective studies (level of evidence: 2b-3b) [17,23]. As for surgical procedures, 10 studies compared SSLF with ASC [15,16,18,[20][21][22][23][24][25]28] [14,17,19,26], and 1 compared ASC, LSC, and SSLF [27].…”

“…The characteristics of the studies included are shown in Table 1 . There were 5 RCTs [ 14 , 20 , 21 , 25 , 28 ] (level of evidence: 2b) [ 29 ]; 8 retrospective studies [ 15 , 16 , 18 , 19 , 22 , 24 , 26 , 27 ] and 2 prospective studies (level of evidence: 2b–3b) [ 17 , 23 ]. As for surgical procedures, 10 studies compared SSLF with ASC [ 15 , 16 , 18 , 20 – 25 , 28 ], 4 compared SSLF with LSC [ 14 , 17 , 19 , 26 ], and 1 compared ASC, LSC, and SSLF [ 27 ].…”

Prospective analysis of transvaginal mesh hysteropexy in the treatment of uterine prolapse

“…In the LAVA trial [23], laparoscopic sacrohysteropexy was found to be non-inferior for surgical failure compared with sacrospinous hysteropexy. The 5-year follow-up of the original SAVE-U study by Schulten et al [24] showed that treatment of uterine prolapse with sacrospinous hysteropexy is effective and has lower risk of recurrent bothersome uterine prolapse or retreatment of the apical compartment compared with vaginal hysterectomy with uterosacral ligament suspension.…”

Authors' reply re: Hysteropexy in the treatment of uterine prolapse stage 2 or higher: laparoscopic sacrohysteropexy versus sacrospinous hysteropexy—a multicentre randomised controlled trial (LAVA trial)

“…We thank Huang et al for their interest and for taking the time to raise some questions regarding our study 1,2 …”