Manchester Procedure vs Sacrospinous Hysteropexy for Treatment of Uterine Descent

Abstract

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

Manchester Procedure vs Sacrospinous Hysteropexy for Pelvic Organ Prolapse

“…Therefore, while this trial reported higher success rates with the Manchester procedure, the SAVE U trial’s 5-year follow-up indicated sacrospinous hysteropexy’s effectiveness. We speculate that the improved outcome of the Manchester procedure, as seen in this study, could be a result of the added steps similar to the uterosacral ligament suspension. Given the contrasting conclusions, we would like to understand the underlying factors that the authors believe contributed to the divergent findings in these studies.…”

“…To the Editor A recent study compared the outcomes of 2 surgeries for pelvic organ prolapse: the Manchester procedure and sacrospinous hysteropexy. Two years after surgery, the Manchester procedure, which preserved the uterus, showed a higher success rate (87.3% vs 77.0%).…”

Patient Impression of Improvement 1 year After Sacrospinous Hysteropexy Versus Vaginal Hysterectomy in Women with Pelvic Organ Prolapse Stage 2 or Higher

“…The secondary outcome was a composite outcome of surgical success, defined as the absence of recurrent POP beyond the hymen with bothersome bulge symptoms and/or repeat surgery at the 1-year follow-up. This definition of POP assessment after treatment was recommended by Barber et al [ 11 ] and was used in other large RCTs such as Detollenaere et al [ 7 ] and Enklaar et al [ 18 ]. The three components of the composite outcome are reported separately.…”

Manchester Procedure vs Sacrospinous Hysteropexy for Pelvic Organ Prolapse—Reply

“…In Reply We appreciate the thoughtful comments of Dr Ye and colleagues and respond on behalf of the entire SAM Study Group . In the SAM study, we proved inferiority of sacrospinous hysteropexy compared with the Manchester procedure for the techniques as applied in the SAM study.…”