Sexual function after the manchester procedure versus sacrospinous hysteropexy in women treated for uterine prolapse: a planned analysis of a randomized clinical trial.

Abstract

While sexual function typically improves after pelvic organ prolapse surgery, there are still general concerns about the risk of developing de novo dyspareunia. A recent randomized clinical trial showed inferiority of the sacrospinous hysteropexy compared to the Manchester procedure regarding surgical success at 2-year follow-up. In this study, we present the data regarding postoperative sexual function from this randomized clinical trial. This study compares the effect of sacrospinous hysteropexy and the Manchester procedure on sexual function and (de novo) dyspareunia at 24-month follow-up and tests whether both procedures are equivalent within predefined margins. Analysis of the data on sexual function from a multicenter randomized clinical trial evaluating Manchester procedure vs sacrospinous hysteropexy in the treatment of primary mild to moderate uterine prolapse. The primary outcome was the change in score on the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-IUGA-Revised between baseline and 24-month follow-up. An equivalence design was applied with a predefined margin of ±0.31 points, corresponding to the minimally clinically important difference for the total Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-IUGA-Revised score. Sexually active and inactive women completed different questionnaires, and therefore patients who crossed over to the other activity status were analyzed separately. Secondary outcomes were the incidence of dyspareunia and de novo dyspareunia. A total of 393 women (Manchester procedure=197, sacrospinous hysteropexy=196) completed the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-IUGA-Revised questionnaire at baseline and after 24 months of follow-up. In sexually active patients (Manchester procedure=101, sacrospinous hysteropexy=99), the mean Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-IUGA-Revised score improved within the groups: 0.27 points (95% confidence interval, 0.19-0.34) after Manchester procedure and 0.20 points (95% confidence interval, 0.11-0.29) after sacrospinous hysteropexy. The mean difference between Manchester procedure and sacrospinous hysteropexy was 0.09 (95% confidence interval, 0.01-0.17), which lies entirely within the predefined equivalence margin of ±0.31, indicating equivalence regarding improvement in sexual function. This difference favored Manchester procedure, but was below the minimally clinically important difference. De novo dyspareunia in sexually active patients did not differ significantly between groups (Manchester procedure 5%, sacrospinous hysteropexy 13%; 95% confidence interval, 0.1% to 16.5%). After incorporating outcomes from women who became nonsexually active postsurgery, de novo dyspareunia was 6% (n=7) in the Manchester procedure group and 11% (n=12) in the sacrospinous hysteropexy group (95% confidence interval, 1.5% to 13.9%). In nonsexually active patients (Manchester procedure=59, sacrospinous hysteropexy=64), the condition-impact score decreased after both Manchester procedure (-0.25 [95% confidence interval, -0.43 to 0.08]) and sacrospinous hysteropexy (-0.21 [95% confidence interval, -0.41 to 0.00]), indicating a lesser impact of the condition on sexual activity status. No differences were observed between the procedures in condition-impact score. Twenty-four percent of patients (Manchester procedure, n=20; sacrospinous hysteropexy, n=19) who had not been sexually active preoperatively transitioned to a sexually active status at 24 months postoperatively. Manchester procedure and sacrospinous hysteropexy lead to a similar improvement in sexual function, and there are no relevant differences in questionnaire scores and de novo dyspareunia rates between groups. Manchester procedure has previously shown to be more effective with regards to the pelvic organ prolapse-related outcomes, and in the present study, a similar positive impact on sexual function was found.