Purpose of trial: Perigee System study is a research study to assess the treatment outcomes for women undergoing anterior vaginal wall prolapse repair utilizing the Perigee system with porcine dermis.

Anterior vaginal prolapse (also known as cystocele) involves the "herniation" of the bladder base into the vagina. It is estimated that 70-80% of these cases are a result of the detachment of the supporting fascia from their anchorage points along the pelvic wall. This study involves a new procedure to treat the anterior vaginal wall prolapse to allow the suspension of a graft (porcine dermis) via the obturator membranes without the need for extensive pelvic sidewall dissection.

Participation in this study will last 24 months and will involve up to 7 office visits. All patients will be evaluated at baseline (pre-operation), and at 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months post-procedure.

Trial Sponsor: American Medical System

Enrollment status: Open

Contact for participation consideration: Robbin Clark, RN;
704-355-7466; robbin.clark@carolinashealthcare.org