Manchester Procedure vs Sacrospinous Hysteropexy for Treatment of Uterine Descent: A Randomized Clinical Trial

Question  Is sacrospinous hysteropexy noninferior to the Manchester procedure for treatment of uterine descent that is not beyond the hymen?

Findings  This noninferiority randomized clinical trial included 434 patients with uterine descent that did not protrude beyond the hymen. The composite outcome of success after 2 years was lower for sacrospinous hysteropexy compared with the Manchester procedure (ie, did not meet noninferiority criteria).

Meaning  In patients with uterine descent that did not protrude beyond the hymen, the lower composite 2-year outcomes are consistent with inferiority of sacrospinous hysteropexy compared with the Manchester procedure.

Importance  In 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.

Objective  To compare success of sacrospinous hysteropexy vs the Manchester procedure for the surgical treatment of uterine descent.

Design, Setting, and Participants  Multicenter, 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.

Interventions  Participants were randomly assigned to undergo sacrospinous hysteropexy (n = 217) or Manchester procedure (n = 217).

Main Outcomes and Measures  The 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.

Results  Among 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.

Conclusions  Based 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 Registration  TrialRegister.nl Identifier: NTR 6978