A multicenter prospective trial evaluating fetal bovine dermal graft (Xenform® Matrix) for pelvic reconstructive surgery.

ABSTRACT:

Background

A prospective multicenter clinical study was performed to evaluate the safety and efficacy of a bovine dermal graft (Xenform® Matrix, Boston Scientific, Natick, MA, USA) during vaginal reconstructive surgery.

Methods

Forty-five women with ICS stage 2 or higher pelvic organ prolapse (POP) were enrolled at 4 centers. POP-Q, pelvic floor function (PFDI-20), sexual function (PISQ-12), and patient satisfaction tools were used to assess subjects at baseline, and at 2 and 6 weeks, and 3, 6 and 12 months post surgery. The significance of symptom score changes at 6 months and 1 year were determined by the t-test for paired data. Forty-three of the 45 patients completed the 12 month study.

Results

The majority of the subjects had cystocele (98%) and/or rectocele (84%

SUBMITTER: Goldstein HB 

PROVIDER: S-EPMC3017018 | biostudies-literature | 2010 Dec

REPOSITORIES: biostudies-literature