Surgical Intervention With DermaPure vs Native Tissue in Pelvic Organ Prolapse

NCT ID: NCT03939715

Last Updated: 2020-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-05
• Study Completion Date: 2022-05-05

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DermaPure

Group Type: ACTIVE_COMPARATOR

DermaPure®

Intervention Type: BIOLOGICAL

Surgical intervention using DermaPure®

Native Tissue

Group Type: ACTIVE_COMPARATOR

native tissue

Intervention Type: PROCEDURE

Surgical intervention using native tissue

Interventions

DermaPure®

Surgical intervention using DermaPure®

Intervention Type: BIOLOGICAL

native tissue

Surgical intervention using native tissue

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tissue Regenix Ltd

INDUSTRY

Sponsor Role: collaborator

Colorado Pelvic Floor Consultants

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Lukban, DO

Role: PRINCIPAL_INVESTIGATOR

Colorado Pelvic Floor Consultants

Locations

Colorado Pelvic Floor Consultants

Englewood, Colorado, United States

Countries

United States

Central Contacts

CATHERINE JAY

Role: CONTACT

cjay@surgone.com

3039558059

Facility Contacts

CATHERINE JAY

Role: primary

303-955-8059

Other Identifiers

1385925-1

Identifier Type: -

Identifier Source: org_study_id