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

Abstract

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.

Figure 1.. Illustration of Sacrospinous Hysteropexy and Manchester Procedure Techniques

Figure 2.. Participant Flow

POP-Q indicates Pelvic Organ Prolapse Quantification. ^aPatients aged 18 years or older with symptomatic pelvic organ prolapse planning to undergo a vaginal uterus-preserving operation were screened for inclusion. There were no screening logs of eligible patients maintained at the 26 participating centers. For privacy reasons, the ethics committee did not permit collection of any anonymized data of screened nonparticipants. This made collection of the number of eligible patients prone to missing and double counts. ^bOther procedures included vaginal hysterectomy (n = 1), anterior colporrhaphy and midurethral sling (n = 1), anterior and posterior colporrhaphy and perineal repair (n = 1), and posterior colporrhaphy (n = 1). ^cTwo patients in the Manchester procedure group did not complete 2-years follow-up but were analyzed as having not met the composite outcome of surgical success. The patients underwent retreatment for recurrent pelvic organ prolapse before loss to follow-up and therefore did meet the criterion for the composite outcome.