Long-term outcome of porcine skin graft in surgical treatment of recurrent pelvic organ prolapse. An open randomized controlled multicenter study.

OBJECTIVE To determine the long-term objective and subjective outcomes of use of a porcine skin graft (Pelvicol) compared with conventional colporrhaphy in recurrent pelvic organ prolapse surgery and to analyze risk factors and safety. DESIGN Open randomized controlled multicenter study. SETTING Eight Swedish hospitals. POPULATION 135 consecutive women with recurrent cystocele and/or rectocele admitted for vaginal prolapse surgery; 132 completed the study, 64 were randomly allocated to receive conventional colporrhaphy and 68 to Pelvicol. METHODS Conventional anterior and posterior colporrhaphy and colporrhaphy with use of Pelvicol mesh reinforcement. Clinical evaluation by means of pelvic organ prolapse quantification (POP-Q) and symptom questionnaire preoperatively, three months and three years postoperatively. MAIN OUTCOME MEASURES Anatomical and subjective outcome. Recurrence was defined as POP-Q ≥ stage 2. RESULTS At three-month follow-up, early recurrence/surgical failures occurred significantly more often in the Pelvicol group, but at the three-year follow-up the recurrence rates were similar. The recurrence rates in the anterior compartment were 57-62% and 44-23% in the posterior compartment for the colporrhaphy and Pelvicol groups, respectively. Symptoms were substantially and equally reduced in the two groups after surgery. Sexual activity and function did not seem to be affected adversely in any group. The complication rate was low. Risk factors for anatomical recurrence were age, body mass index and preoperative stage of the prolapse. CONCLUSIONS With the surgical technique used in this study, Pelvicol did not provide advantages over conventional colporrhaphy in recurrent pelvic organ prolapse concerning anatomical and subjective outcomes.