[Efficacy and safety of Pelvicol in the vaginal treatment of prolapse].

OBJECTIVES

To evaluate the efficacy and safety of a porcine biomaterial (Pelvicol) in the transvaginal surgical treatment of urogenital prolapse.

MATERIAL AND METHOD

Prospective study from June 2001 to February 2004 based on 132 patients with a mean age of 67.6 +/- 9.89 years presenting major urogenital prolapse: 132 cystoceles and 84 rectoceles with 100% and 63.4% of grade 2 or 3, respectively. Patients were evaluated by questionnaire and clinical examination at 1 month, 6 months, 12 months and 24 months after the operation. Two hundred and sixteen Pelvicol implants were inserted via a vaginal approach: 132 anterior implants and 84 posterior implants.

RESULTS

The mean follow-up was 21 months [range: 6-24]. No intraoperative complication was observed. The postoperative complication rate was 11.3% (15/132) including 1 prosthetic exposure with a favourable outcome. After 6 months, 1 recurrence of cystoceles and 1 recurrence of rectoceles were found in 132 patients. Out of the 117 patients followed up for 12 months, 6 presented with grade 2 cystoceles and 1 grade 2 rectoceles. After 24 months, out of the 107 patients evaluated, 18 cystoceles and 9 rectoceles of grade 2 or 3 were found. Globally, 83.1% of patients did not present with grade 2 or 3 recurrences after 24 months. Safety was considered to be good with 10% of moderate pelvic pain and 6% of de novo dyspareunia at 12 months. The overall satisfaction rate was 94%.

CONCLUSION

These preliminary results demonstrate an efficacy of 83.1% at 24 months and the good safety of Pelvicol in the transvaginal surgical treatment of urogenital prolapse.