The Efficacy of Laparoscopic Sacrocolpopexy in the Treatment of Pelvic Organ Prolapse in Women With or Without Avulsion of the Levator Ani Muscle

Introduction Pelvic organ prolapse (POP), is a common health problem affecting up to 40% of women. The life time risk for undergoing at least one session of pelvic organ prolapse surgery has been estimated at approximately 13%. The prevalence of reoperation after primary pelvic reconstructive surgery is high, around 30%, while some articles report the figure as up to 58%. From the beginning of the 1990s the view of pelvic floor defects and urinary incontinence in women started to change significantly. The diagnostics and management of these defects became an independent uro-gynecological sub-specialization within gynecology and obstetrics, and it has been included among 4 basic sub-specializations recognized by the European Board and College of Obstetrics and Gynecology. Surgical treatment is indicated in women with symptomatic POP when conservative management has failed or has been declined. There is no indication for repair of asymptomatic POP as an isolated procedure where surgical correction is of uncertain benefit and adds peri- and post-operative risks. The objective of our treatment should always aim to restore quality of life and comfort. Very little is known of the factors associated with surgical failure. Studies have identified a variety of risk factors: younger age, high body mass index and advanced preoperative prolapse (grade III-IV) were associated with an increased risk of reoperation in some studies, while other studies did not prove these hypotheses. One factor which significantly influences the result of the pelvic organ surgery is the presence of pelvic floor injury. Injury of the levator ani muscle mainly affects the results of traditional vaginal wall repair, with 60% risk of recurrence. In the last few years, in an attempt to reduce recurrence and improve the outcome of reconstructive surgery in the treatment of pelvic organ prolapse, surgeons have started to use transvaginally introduced prosthetic material (mesh). This type of surgery significantly increases the efficacy of the procedure (anatomic cure rate over 90%), but its use is associated with a risk of some complications (vaginal erosions and potential consecutive infections, granulomas, dyspareunia, vesico-vaginal fistulas, chronic pain) thereby potentially reducing the patients' quality of life and leading to additional surgery. If the mesh is introduced during the sacrocolpopexy and the vaginal wall is not open, there is a significant decrease of mesh-related complications. Laparoscopic sacrocolpopexy is considered the gold standard for the management of apical prolapse with high long-term efficacy. Based on the retrospective data available, it seems that the status of the pelvic floor may also influence the results of this procedure, but at present investigators have no data to confirm this hypothesis. Therefore investigators plan to obtain these data from a prospective analysis of the results of laparoscopic sacrocolpopexy.

For the prospective longitudinal study, the investigators plan to include all patients for whom surgical treatment of pelvic organ prolapse and laparoscopic sacrocolpopexy are indicated. Based on pre-study power analysis enrollment of 120 patients is planned (after preliminary evaluation of the results this could be increased to 160 patients), which is the minimal number to prove or disprove the null hypothesis: The pelvic floor does not influence the result of laparoscopic sacrocolpopexy in women with symptomatic pelvic organ prolapse stage II or higher. Based on previous studies it can be anticipated that the failure rate in patients with a defect of the pelvic floor will be higher. To enroll an adequate number of patients the study will be conducted in two university centers with long experience of this type of surgery (the number of enrolled patients in each workplace should be identical). Based on pre-study statistical calculations (power analysis) it is indicated that the required sample size for final statistical analysis in each group is 54 patients (allocation ratio 1:1). Investigators estimate a drop-out rate of 10%, therefore it is planned to enroll 60 patients into each group.

Aim of the study Based on a prospective study, to evaluate how pre-operative pelvic floor status - the presence of injury to the musculus levator ani - may influence the results of laparoscopic sacrocolpopexy. The investigators hope to confirm or disprove the hypothesis that the presence of such injury increases the risk of post-operative prolapse recurrence.

Inclusion criteria are:

Age over 18, signed informed consent, symptomatic pelvic organ prolapse stage II or higher (according to the International Continence Society Pelvic Organ Prolapse quantification system - POPQ) in anterior and apical (central) compartment, and agreement with postoperative follow-up.