Introduction and hypothesis: We compared vaginal hysterectomy with bilateral sacrospinous fixation plus an anterior polyvinylidene fluoride mesh versus abdominal sacrocolpopexy for the treatment of primary apical prolapse in postmenopausal women.
Methods: A prospective, randomized, single-blind, parallel study [Registro Brasileiro de Ensaios Clinicos (REBEC) trial register code RBR-7t6rg2] was performed from October 2015 to May 2016. A total of 71 postmenopausal women with advanced pelvic organ prolapse (POP) and undergoing surgery were randomized to the abdominal sacrocolpopexy (ASC) (n = 36) or the vaginal sacrospinous fixation with anterior mesh (VSF-AM) (n = 35) groups. Pelvic Organ Prolapse Quantification (POP-Q) system classification was performed for objective assessment, and the International Consultation on Incontinence Questionnaire-Vaginal Symptoms (ICIQ-VS), International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), and International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB) questionnaires were filled out for subjective evaluation by women before and 1 year after surgery. All procedures were performed by a single surgeon.
Results: Both groups had improvement in almost POP-Q points (except for vaginal length in the VSF-AM group) and all ICIQ scores. The ASC group had a longer operative time (129 versus 117 min, p = 0.0038) and duration for return to activities (103 versus 57 days, p < .05). Four women (11%) in the VSF-AM group were reoperated versus none from the ASC group (p = .05).
Conclusions: Although the study did not achieve the planned recruitment, after 12 months of follow-up, ASC did not differ from VSF-AM in objective and subjective scores (ICIQ questionnaires; POP-Q measurements). Recovery time was longer after open abdominal surgery.
Keywords: Pelvic organ prolapse; Polyvinylidene; Randomized controlled trial; Sacrocervicopexy; Synthetic mesh; Vaginal sacrospinous fixation.