Clinical trial NCT03939715: Surgical Intervention With DermaPure vs Native Tissue in Pelvic Organ Prolapse
Official title: Anterior And Multi-Compartment Vaginal Prolapse Repair Augmented With Decellularized Human Dermal Allograft: A Prospactive, Randomized Controlled, Post Market Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pelvic Organ Prolapse
Lead sponsor: Colorado Pelvic Floor Consultants
Sponsor class: INDUSTRY
Collaborators: name: Tissue Regenix Ltd
First posted: 2019-05-07
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: Safety through AE and SAE assessments and percentage of incidences
timeFrame: 3 years
measure: Quality of Life through the administration of questionnaires, analyzed at the end of the study as % of patients that are satisfied or above satisfied
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Colorado Pelvic Floor Consultants
state: Colorado
Study officials:
affiliation: Colorado Pelvic Floor Consultants
name: James Lukban, DO
role: PRINCIPAL_INVESTIGATOR
References: