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Randomized Controlled Trial
. 2020 Sep;127(10):1284-1293.
doi: 10.1111/1471-0528.16242. Epub 2020 May 10.

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

M N van IJsselmuiden  1   2 , Amj van Oudheusden  2 , J Veen  3 , G van de Pol  4 , A Vollebregt  5 , C M Radder  6 , S Housmans  7 , Smj van Kuijk  2 , J Deprest  7 , M Y Bongers  2   3 , Hwf van Eijndhoven  1
Affiliations
Randomized Controlled Trial

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

M N van IJsselmuiden et al. BJOG. 2020 Sep.

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.

Keywords: Apical prolapse; hysteropexy; laparoscopic; mesh; uterine prolapse; uterine suspension.

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References

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