Comparing Laparoscopic Sacrocolpopexy with Vaginal Sacrospinous Ligament Fixation in the Treatment of Vaginal Apical Prolapse; the First Randomized Clinical Trial: A pilot study.

Abstract

To compare two methods of laparoscopic sacrocolpopexy (LSCP) and sacrospinous ligament fixation (SSLF) in terms of efficacy and safety in the treatment of vaginal apical prolapse. This prospective, randomized controlled clinical trial was conducted on 32 patients with symptomatic vaginal apical prolapse, referred to the female urology clinic of Kerman University, Iran, during 2018-2019. The patients were re-examined at 12 months after surgery. Objective success was recorded using Pelvic Organ Prolapse Quantification (POP-Q) classification as primary outcome. The subjective success of the methods was determined by the quality-of-life parameters, based on Pelvic Floor Impact Questionnaire (PFIQ-7), Pelvic Floor Distress Inventory (PFDI-20), and Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) scores as secondary outcomes. Moreover, complications were recorded in both groups. The amount of intraoperative bleeding was significantly higher in the SSLF group, compared to the LSCP group (P = 0.01). Persistent pain was observed in two (12%) patients in the LSCP group and five (31%) patients in the SSLF group (P = 0.2). The decrease in the total PFIQ-7 score was in favor of the LSCP group but not statistically significant (p = 0.06). The LSCP group showed bigger improvement in vaginal (p = 0.04) and bowel (p = 0.03) scores. The results of the PISQ-12 and PFDI-20 questionnaires as well as POP-Q examination were not different in two groups. Although the surgical methods of LSCP and SSLF can be equally effective in the treatment of apical prolapse, LSCP appears to be superior to SSLF regarding less bleeding.