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

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

Study Overview

• Status: Unknown
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Biological: DermaPure®; Procedure: native tissue

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)

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: CATHERINE JAY; Phone Number: 3039558059; Email: cjay@surgone.com

Study Locations

• United States
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Colorado Pelvic Floor Consultants
      • Contact: CATHERINE JAY; Phone Number: 303-955-8059

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion criteria:

• Subject is female
• Subject is at least 18 years of age
• Subject has prolapse of the anterior compartment beyond the hymen
• Subject reports bulge symptoms as defined in question 3 of the PFDI-20 with a response of 2 or higher ("somewhat", "moderately" or "quite a bit")
• Subject is willing and able to provide informed consent
• Subject is willing and able to comply with the follow-up protocol through 36 months

Exclusion criteria:

• Subject is pregnant or intends to become pregnant during the study
• Subject has untreated severe urogenital atrophy
• Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI), or tissue necrosis
• Subject has a history of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical)
• Subject has had prior pelvic radiation therapy
• Subject has taken systemic steroids within the last month, or immunosuppressive or immunomodulatory treatment within the last 3 months (list attached)
• Subject has a history of poor wound healing with or without a diagnosis of connective tissue disease
• Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis
• Subject has uncontrolled diabetes mellitus (DM) as defined by a hemoglobin A1C < or = to 8% (Underwood, Ata)
• Subject has a known neurologic or medical condition that may effect of currently affects bladder function
• Subject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis)
• Subject is not able to conform to the modified dorsal lithotomy position
• Subject is currently participating in or plans to participate in another pelvic organ prolapse related study during this study
• Subject has had previous prolapse repair with synthetic mesh in the anterior compartment
• Subject is planning to undergo a concomitant prolapse repair in a non-target compartment with anything other than native tissue or DermaPure®
• Subject is unable to be treated in the anterior compartment with DermaPure®
• Subject is desirous of a concomitant hysteropexy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DermaPure	Biological: DermaPure®; Surgical intervention using DermaPure®
Active Comparator: Native Tissue	Procedure: native tissue; Surgical intervention using native tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety through AE and SAE assessments and percentage of incidences	The relative proportion of allograft, native tissue, and procedure-related SAE's is assessed at 12 months, 24 months, and 36 months. The relative proportion of allograft, native tissue, and procedure-related AE's of interest is assessed at 12 months, 24 months, and 36 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)	3 years
Quality of Life through the administration of questionnaires, analyzed at the end of the study as % of patients that are satisfied or above satisfied	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 ("Do you usually have a bulge or something falling out that you can see or feel in the vaginal area") answering "yes" and >= 2 (responses of "somewhat", "moderately", or "quite a bit"). (Barber) Change in quality of life in each group from baseline to 36 months as measured by the PFDI-20 and the PFIQ-7. (Barber)	3 years

Collaborators and Investigators

• Sponsor: Colorado Pelvic Floor Consultants
• Collaborators: Tissue Regenix Ltd
• Investigators: Principal Investigator: James Lukban, DO, Colorado Pelvic Floor Consultants

Study record dates

Study Major Dates

• Study Start (Anticipated): April 5, 2020
• Primary Completion (Anticipated): May 5, 2022
• Study Completion (Anticipated): May 5, 2022

Study Registration Dates

• First Submitted: April 30, 2019
• First Submitted That Met QC Criteria: May 3, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Actual): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 21, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: 1385925-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No