NCT03939715

Surgical Intervention With DermaPure vs Native Tissue in Pelvic Organ Prolapse

Anterior And Multi-Compartment Vaginal Prolapse Repair Augmented With Decellularized Human Dermal Allograft: A Prospactive, Randomized Controlled, Post Market Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Colorado Pelvic Floor Consultants · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Comparing FDA-approved DermaPure with patient's own native tissue surgically for diagnosis of pelvic organ prolapse.

Detailed description

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)

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
BIOLOGICAL	DermaPure®	Surgical intervention using DermaPure®
PROCEDURE	native tissue	Surgical intervention using native tissue

Timeline

• Start date: 2020-04-05
• Primary completion: 2022-05-05
• Completion: 2022-05-05
• First posted: 2019-05-07
• Last updated: 2020-01-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study