• Rosa A Enklaar, Sascha F M Schulten, van EijndhovenHugo W FHWFDepartment of Obstetrics and Gynecology, Isala, Zwolle, the Netherlands., Mirjam Weemhoff, Sanne A L van Leijsen, Marijke C van der Weide, Jeroen van Bavel, Anna C Verkleij-Hagoort, AdangEddy M MEMMDepartment for Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands., Kirsten B Kluivers, and SAM Study Group.
• Department of Obstetrics and Gynecology, Radboud University Medical Center, Nijmegen, the Netherlands.
• JAMA. 2023 Aug 15; 330 (7): 626635626-635.

ImportanceIn many countries, sacrospinous hysteropexy is the most commonly practiced uterus-preserving technique in women undergoing a first operation for pelvic organ prolapse. However, there are no direct comparisons of outcomes after sacrospinous hysteropexy vs an older technique, the Manchester procedure.ObjectiveTo compare success of sacrospinous hysteropexy vs the Manchester procedure for the surgical treatment of uterine descent.Design, Setting, And ParticipantsMulticenter, noninferiority randomized clinical trial conducted in 26 hospitals in the Netherlands among 434 adult patients undergoing a first surgical treatment for uterine descent that did not protrude beyond the hymen.InterventionsParticipants were randomly assigned to undergo sacrospinous hysteropexy (n = 217) or Manchester procedure (n = 217).Main Outcomes And MeasuresThe primary outcome was a composite outcome of success, defined as absence of pelvic organ prolapse beyond the hymen in any compartment evaluated by a standardized vaginal support quantification system, absence of bothersome bulge symptoms, and absence of prolapse retreatment (pessary or surgery) within 2 years after the operation. The predefined noninferiority margin was 9%. Secondary outcomes were anatomical and patient-reported outcomes, perioperative parameters, and surgery-related complications.ResultsAmong 393 participants included in the as-randomized analysis (mean age, 61.7 years [SD, 9.1 years]), 151 of 196 (77.0%) in the sacrospinous hysteropexy group and 172 of 197 (87.3%) in the Manchester procedure group achieved the composite outcome of success. Sacrospinous hysteropexy did not meet the noninferiority criterion of -9% for the lower limit of the CI (risk difference, -10.3%; 95% CI, -17.8% to -2.8%; P = .63 for noninferiority). At 2-year follow-up, perioperative outcomes and patient-reported outcomes did not differ between the 2 groups.ConclusionsBased on the composite outcome of surgical success 2 years after primary uterus-sparing pelvic organ prolapse surgery for uterine descent, these results support a finding that sacrospinous hysteropexy is inferior to the Manchester procedure.Trial RegistrationTrialRegister.nl Identifier: NTR 6978.

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