title: Sacrospinous hysteropexy versus vaginal hysterectomy with suspension of the uterosacral ligaments in women with uterine prolapse stage 2 or higher: multicentre randomised non-inferiority trial.
abstract: OBJECTIVE
  To investigate whether uterus preserving vaginal sacrospinous hysteropexy is non-inferior to vaginal hysterectomy with suspension of the uterosacral ligaments in the surgical treatment of uterine prolapse.
  
  
  METHODS
  Multicentre randomised controlled non-blinded non-inferiority trial.
  
  
  METHODS
  4 non-university teaching hospitals, the Netherlands.
  
  
  METHODS
  208 healthy women with uterine prolapse stage 2 or higher requiring surgery and no history of pelvic floor surgery.
  
  
  METHODS
  Treatment with sacrospinous hysteropexy or vaginal hysterectomy with suspension of the uterosacral ligaments. The predefined non-inferiority margin was an increase in surgical failure rate of 7%.
  
  
  METHODS
  Primary outcome was recurrent prolapse stage 2 or higher of the uterus or vaginal vault (apical compartment) evaluated by the pelvic organ prolapse quantification system in combination with bothersome bulge symptoms or repeat surgery for recurrent apical prolapse at 12 months' follow-up. Secondary outcomes were overall anatomical recurrences, including recurrent anterior compartment (bladder) and/or posterior compartment (bowel) prolapse, functional outcome, complications, hospital stay, postoperative recovery, and sexual functioning.
  
  
  RESULTS
  Sacrospinous hysteropexy was non-inferior for anatomical recurrence of the apical compartment with bothersome bulge symptoms or repeat surgery (n=0, 0%) compared with vaginal hysterectomy with suspension of the uterosacral ligaments (n=4, 4.0%, difference -3.9%, 95% confidence interval for difference -8.6% to 0.7%). At 12 months, overall anatomical recurrences, functional outcome, quality of life, complications, hospital stay, measures on postoperative recovery, and sexual functioning did not differ between the two groups. Five serious adverse events were reported during hospital stay. None was considered to be related to the type of surgery.
  
  
  CONCLUSIONS
  Uterus preservation by sacrospinous hysteropexy was non-inferior to vaginal hysterectomy with suspension of the uterosacral ligaments for surgical failure of the apical compartment at 12 months' follow-up.
  
  
  BACKGROUND
  trialregister.nl NTR1866.
authors.affiliation: Department of Obstetrics and Gynaecology, Isala, PO Box 10400, 8000 GK Zwolle, Netherlands Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands r.j.detollenaere@isala.nl.
authors.forename: Renée J
authors.initials: RJ
authors.lastname: Detollenaere
authors.affiliation: Department of Obstetrics and Gynaecology, Isala, PO Box 10400, 8000 GK Zwolle, Netherlands.
authors.forename: Jan
authors.initials: J
authors.lastname: den Boon
authors.affiliation: Department of Obstetrics and Gynaecology, Medical Centre Leeuwarden, Leeuwarden, Netherlands.
authors.forename: Jelle
authors.initials: J
authors.lastname: Stekelenburg
authors.affiliation: Radboud Institute for Health Sciences, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands.
authors.forename: Joanna
authors.initials: J
authors.lastname: IntHout
authors.affiliation: Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands.
authors.forename: Mark E
authors.initials: ME
authors.lastname: Vierhout
authors.affiliation: Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands.
authors.forename: Kirsten B
authors.initials: KB
authors.lastname: Kluivers
authors.affiliation: Department of Obstetrics and Gynaecology, Isala, PO Box 10400, 8000 GK Zwolle, Netherlands.
authors.forename: Hugo W F
authors.initials: HW
authors.lastname: van Eijndhoven
mesh_terms: D001956:Broad Ligament / Q000601:surgery*; D005260:Female; D013509:Gynecologic Surgical Procedures / Q000379:methods*; D006801:Humans; D007044:Hysterectomy / Q000379:methods; D007902:Length of Stay / Q000706:statistics & numerical data; D008875:Middle Aged; D009426:Netherlands / Q000453:epidemiology; D059351:Organ Sparing Treatments / Q000379:methods*; D011788:Quality of Life; D012008:Recurrence; D012404:Round Ligament of Uterus / Q000601:surgery*; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014596:Uterine Prolapse / Q000473:pathology / Q000601:surgery*; D014599:Uterus / Q000473:pathology / Q000601:surgery*; D016387:Women's Health