Surgical Intervention With DermaPure vs Native Tissue in Pelvic Organ Prolapse

Colorado Pelvic Floor Consultants

Status and phase

Unknown

Phase 4

Conditions

Pelvic Organ Prolapse

Treatments

Biological: DermaPure®

Procedure: native tissue

Study type

Interventional

Funder types

Industry

Identifiers

NCT03939715

1385925-1

Details and patient eligibility

About

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

Full 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)

Enrollment

50 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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