The purpose of this study is to compare transvaginal mesh repair to traditional native
tissue repair in women surgically treated for anterior/apical pelvic organ prolapse with or
without concurrent cystocele.
1. Subject is female
2. Subject is ≥18 years of age
3. Subject has pelvic organ prolapse with the leading edge at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Ba≥0 or C≥0 (for prolapse of the apical compartment alone) or C≥-1/2 TVL (for a multi-compartment prolapse that includes the apical compartment).
4. Subject reports of a bothersome bulge they can see or feel per PFDI-20, question 3 response of 2 or higher (i.e. responses of "somewhat", "moderately" or "quite a bit")
5. Subject or subject's legally authorized representative must be willing to provide written informed consent
6. Subject is willing and able to comply with the follow-up regimen
7. Subject has had a total hysterectomy
1. Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI) or tissue necrosis
2. Subject has history of pelvic organ cancer (e.g. uterine, ovarian, bladder, colo-rectal or cervical)
3. Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area
4. Subject has taken systemic steroids (within the last month) or immunosuppressive or immunomodulatory treatment (within the last 3 months)