Surgical Intervention With DermaPure vs Native Tissue in Pelvic Organ Prolapse

Pelvic Organ Prolapse Clinical Trial

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

Status Not yet recruiting

Clinical Trial Summary

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

Clinical Trial 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) ;

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

• NCT number: NCT03939715
• Study type: Interventional
• Source: Colorado Pelvic Floor Consultants
• Contact: CATHERINE JAY
• Phone: 3039558059
• Email: cjay@surgone.com
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 5, 2020
• Completion date: May 5, 2022