Evaluation of Clinical Outcome and Risk Factors for Recurrence after Pelvic Reconstruction of Pelvic Organ Prolapse with Implanted Mesh or Biological Grafts: A Single-Blind Randomized Trial

Abstract

Background: There are few studies on the relative factors related to postoperative recurrence.

Objectives: To compare the outcomes of pelvic floor reconstruction involving Herniamesh mesh and biological grafts and to investigate the correlative factors of postoperative recurrence.

Method: Two hundred and thirty-two patients were randomly divided into 2 groups: Herniamesh mesh group (117) and biological graft group (115). Follow-ups for 6 months and 1 year after the surgery. The primary outcomes were recurrence, perioperative complications. Secondary outcome was a questionnaire about the life habits associated with relapse.

Results: The recurrence rate at 6 months or 1 year did not differ substantially between the 2 groups (p = 0.787 and 0.968, respectively). Adverse events occurred with significantly different frequencies over 1 year (p = 0.005). Twelve factors were investigated and analyzed by logistic regression analysis. It showed that recurrence had a strong association with a long-term vegetarian diet (OR 0.283, 95% CI 0.117-0.683), long-term soybean product diet (OR 8.010, 95% CI 2.514-25.523), and vaginal intercourse (OR 5.154, 95% CI 1.461-18.184).

Conclusions: The surgical recurrence rate for the mesh was similar to biological grafts at short-term follow-up. Eating soy products often and vaginal intercourse after surgery can reduce recurrence.

Keywords: Pelvic organ prolapse; Postoperative complications; Recurrence; Risk factors.