The investigator is comparing FDA-approved DermaPure with patient's own native tissue for the repair of pelvic organ prolapse. Please see below for detailed objectives and endpoints for our measuring parameters:~Objectives~Specific Aim #1:~To determine the relative safety and efficacy of anterior and multi-compartment vaginal wall prolapse repair augmented with decellularized human dermal allograft (DermaPure®) versus anterior and multi-compartment repair employing native tissue.~Specific Aim #2:~To evaluate bulge symptoms, quality of life, sexual function, and patient satisfaction~Our hypothesis is that pelvic organ prolapse repair augmented with DermaPure® will provide superior anatomic outcomes as compared to native tissue controls with a non-inferior safety profile.~Endpoints~Safety Endpoint #1:~The relative proportion of allograft, native tissue, and procedure-related SAE's at 12 months.~Safety Endpoint #2:~The relative proportion of allograft, native tissue, and procedure-related AE's of interest at 12 months, which include:~Vaginal shortening~Vaginal scarring or banding~De novo vaginal bleeding~Atypical vaginal discharge~Fistula formation~De novo dyspareunia~Pelvic pain~Peri-operative infection~Vaginal infection~UTI~Neuromuscular disorder~SUI (worsening or de novo)~UUI (worsening or de novo)~Difficulty emptying bladder (worsening or de novo)~Graft exposure (into vagina)~Graft erosion (into viscus)~Efficacy Endpoint #1:~The proportion of patients in each group at 36 months with prolapse of the target compartment beyond the hymen.~Efficacy Endpoint #2:~The proportion of patients in each group at 36 months with bulge symptoms attributable to the target compartment as determined by PFDI-20 question number 3 (Does the participant usually have a bulge or something falling out that the participant can see or feel in the vaginal area) answering yes and >= 2 (responses of somewhat, moderately, or quite a bit). (Barber)~Efficacy Endpoint #3:~The proportion of patients in each group at 36 months requiring re-treatment for recurrent prolapse of the target compartment (to include surgery, physical therapy or pessary insertion).~Efficacy Endpoint #4:~Change in quality of life in each group from baseline to 36 months as measured by the PFDI-20 and the PFIQ-7. (Barber)~Efficacy Endpoint #5:~Change in sexual function in each group from baseline to 36 months as measured by the PISQ-IR. (Rogers)~Efficacy Endpoint #6:~Patient satisfaction in each group at 36 months as measured by the SSQ-8. (Haff)~Efficacy Endpoint #7:~Patient impression in each group at 36 months of postoperative improvement by the PGI-I (Srikrishna)
Comparing FDA-approved DermaPure with patient's own native tissue surgically for diagnosis of pelvic organ prolapse.