TY - JOUR
T1 - Hysteropexy in the treatment of uterine prolapse stage 2 or higher
T2 - laparoscopic sacrohysteropexy versus sacrospinous hysteropexy-a multicentre randomised controlled trial (LAVA trial)
AU - van IJsselmuiden, M. N.
AU - van Oudheusden, A. M. J.
AU - Veen, J.
AU - van de Pol, G.
AU - Vollebregt, A.
AU - Radder, C. M.
AU - Housmans, S.
AU - van Kuijk, S. M. J.
AU - Deprest, J.
AU - Bongers, M. Y.
AU - van Eijndhoven, H. W. F.
N1 - Funding Information:
The LAVA trial was an investigator‐driven non‐commercial trial. The study received a research grant from the Isala Research Foundation (Zwolle, the Netherlands). The funding source had no role in the design and conduct of the study; collection, management, analysis, or interpretation of the data; or preparation, review or approval of the manuscript.
Publisher Copyright:
© 2020 Royal College of Obstetricians and Gynaecologists
PY - 2020/9
Y1 - 2020/9
N2 - 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.
AB - 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.
KW - Apical prolapse
KW - hysteropexy
KW - laparoscopic
KW - mesh
KW - uterine prolapse
KW - uterine suspension
KW - PELVIC ORGAN PROLAPSE
KW - QUALITY-OF-LIFE
KW - VAGINAL HYSTERECTOMY
KW - UTEROVAGINAL PROLAPSE
KW - URODYNAMIC ASSESSMENT
KW - FOLLOW-UP
KW - WOMEN
KW - INCONTINENCE
KW - SACROCOLPOPEXY
KW - SUSPENSION
U2 - 10.1111/1471-0528.16242
DO - 10.1111/1471-0528.16242
M3 - Article
C2 - 32267624
SN - 1470-0328
VL - 127
SP - 1284
EP - 1293
JO - Bjog-an International Journal of Obstetrics and Gynaecology
JF - Bjog-an International Journal of Obstetrics and Gynaecology
IS - 10
ER -