title: Porcine skin collagen implants to prevent anterior vaginal wall prolapse recurrence: a multicenter, randomized study.
abstract: OBJECTIVE
  We evaluated the efficacy of the Pelvicol porcine collagen implant for preventing recurrent anterior vaginal wall prolapse in women undergoing primary surgery for pelvic organ prolapse.
  
  
  METHODS
  This was a prospective, randomized, multicenter trial in 206 women with stage II or greater anterior vaginal wall prolapse (point Ba -1 or greater) according to the pelvic organ prolapse quantification system. The patients were randomly assigned to undergo anterior vaginal repair or the same procedure with Pelvicol implant reinforcement. SPSS software was used for data analysis.
  
  
  RESULTS
  A total of 201 women were available for surgical outcome analysis, including 98 and 103 in the implant and no implant groups, respectively. All completed the 1-year followup visit. Most women were satisfied with the postoperative condition with a significant decrease in the visual analog scale score in each group (p <0.001). Anatomical anterior recurrence (point Ba greater than -1) was observed in 7 women (7%) in the implant group and in 20 (19%) in the other groups (OR 3.13, 95% CI 1.26-7.78, p = 0.019). Additionally, there were 11 women (3 and 8, respectively, or 5%) with posterior recurrence and 6 (3 per group or 3%) with unsatisfactory results at the upper vaginal segment. One patient who received a porcine implant had vaginal extrusion of the mesh 1 month after surgery.
  
  
  CONCLUSIONS
  Our data show that the Pelvicol implant can be easily and readily used to augment and reinforce anterior colporrhaphy. The prolapse recurrence rate was considerably lower in the implant group compared with outcomes in patients treated with simple anterior repair.
authors.affiliation: Department of Obstetrics and Gynecology, University of Milan, Milan, Italy. m.meschia@libero.it
authors.forename: Michele
authors.initials: M
authors.lastname: Meschia
authors.forename: Paola
authors.initials: P
authors.lastname: Pifarotti
authors.forename: Francesco
authors.initials: F
authors.lastname: Bernasconi
authors.forename: Fabio
authors.initials: F
authors.lastname: Magatti
authors.forename: Diego
authors.initials: D
authors.lastname: Riva
authors.forename: Erwin
authors.initials: E
authors.lastname: Kocjancic
mesh_terms: D000368:Aged; D000818:Animals; D003094:Collagen; D005260:Female; D006801:Humans; D011446:Prospective Studies; D019736:Prostheses and Implants; D012008:Recurrence; D016038:Skin Transplantation; D013552:Swine; D014183:Transplantation, Heterologous; D014596:Uterine Prolapse / Q000517:prevention & control* / Q000601:surgery*
chemical_list: D003094:Collagen