Study of Cytrix Use in Pelvic Floor Prolapse Treatment

Inclusion criteria

• Female >30 years of age
• Willing and able to comply w/ the study procedures and provide written informed consent to participate in the study.
• Diagnosed with pelvic organ prolapse with or without pelvis floor dysfunction
• Patient is willing to complete PFDI-SF20 and PISQ-12 questionnaires at 6 and 12 months post-operatively
• Patient is willing to answer phone questionnaires at 2 weeks, 6 weeks, and 3 months
• Patients with a history of pelvic surgery (cystocele/anterior repair, hysterectomy, vault suspension, etc) prior to this procedure are allowed to participate in the study except if the patient had a dermal graft implanted.

Exclusion criteria

• Patients who, in the clinical judgment of the investigator, are not suitable for this study
• Patients who are, in the Investigators opinion, mentally or legally incapacitated preventing informed consent or unable to read or understand written material.
• Patients who have participated in an investigational study within 30 days of study entry that may impact analysis of this device or have previously participated in the current trial
• Patient whose pelvic organ prolapse is Stage I
• Patient with Diabetes Mellitus type I or II
• Patient with morbid obesity (weight parameters determined by physician)
• Patient with undiagnosed pelvic mass outside of the uterus (not expected to be functional in nature)
• Patient with unexplained abnormal menstrual bleeding
• Patient with any acute or chronic infection (kidney, bladder, lung, etc)
• Patient with coagulopathy
• Patient participating in other investigational device or drug study
• Patients must not be pregnant
• Patients with life expectancy less than 2 years
• Patients with known or suspected hypersensitivity to collagen or bovine products
• Patients with preexisting local or systemic infection
• Patients with a history of soft tissue pathology where the implant is to be placed
• Patients with any pathology that would limit the blood supply and compromise healing
• Patient diagnosed with autoimmune connective tissue disease