Surgical Intervention With DermaPure vs Native Tissue in Pelvic Organ Prolapse

Summary

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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 an...

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)

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